The end of the Brexit Transition Period – Impact on Pharmaceutical Industry

30 Nov 2020 - Online webinar

90 minute live webinar
13:00 (UK/London Time Zone)

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

1-2 Dec 2020 - Online webinar

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

Business and Contract Law

3-4 Dec 2020 - Online webinar

*A two-day no-nonsense plain English practical course* to get to grips with business and contract law for busy business executives.

US Patent Practice

3-4 Dec 2020 - Online webinar

What all European patent attorneys need to know - an intensive and highly interactive two-day seminar including discussions on US patent law and strategies and tactics for patent prosecution at the US Patent Office

IP Due Diligence & Freedom to Operate in Practice

3 Dec 2020 - Online webinar

This intensive one-day course will give you many insights into the best practice of organising and conducting an efficient and thorough IP due diligence project.

How to Write Effective SOPs

3 Dec 2020 - Online webinar

An essential course for ensuring compliance with regulatory requirements which will be of particular relevance for pharmacovigilance, regulatory affairs, clinical research/operations, GMP, QA and document management functions.

Improving Processes and CAPA (Corrective and Preventative Action)

4 Dec 2020 - Online webinar

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.

Project Management for Pharma Professionals

10-11 Dec 2020 - Online webinar

The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health

*Includes:* Interactive workshop sessions

EC Medical Devices Vigilance System and Post Marketing Surveillance

26-27 Jan 2021 - Online webinar

This conference provides a unique opportunity to meet competent authorities, notified bodies, lawyers, consultants and manufacturers to understand and discuss the regulatory and legal requirements with respect to post-marketing surveillance including vigilance.

Clinical Trial Regulatory Requirements

26-27 Jan 2021 - London

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements.

A Practical Guide to Writing Risk Management Plans (RMPs)

28 Jan 2021 - Online webinar

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

Clinical Trial Regulatory Requirements

28-29 Jan 2021 - Online webinar

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements.

EC Medical Devices Vigilance System and Post Marketing Surveillance

28-29 Jan 2021 - London

This conference provides a unique opportunity to meet competent authorities, notified bodies, lawyers, consultants and manufacturers to understand and discuss the regulatory and legal requirements with respect to post-marketing surveillance including vigilance.

A Practical Guide to Producing and Maintaining the PSMF

29 Jan 2021 - Online webinar

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union

2-3 Feb 2021 - London
Also on: 4 Feb 2021

This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.

A Practical Guide to Writing Risk Management Plans (RMPs)

4 Feb 2021 - London

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

A Practical Guide to Producing and Maintaining the PSMF

5 Feb 2021 - London

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

Effective Technical Writing & Editing

11 Feb 2021 - Online webinar
Also on: 12 Feb 2021

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

Drafting Commercial Contracts

15-16 Feb 2021 - London

A practical and interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training of the key drafting skills.

Metered Dose Inhaler (MDI) Technology

16-17 Feb 2021 - Online webinar
Also on: 18 Feb 2021

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

Drafting Commercial Contracts

22-23 Feb 2021 - Online webinar

A practical and interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training of the key drafting skills.

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

23-24 Feb 2021 - Online webinar

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

Patentability and State-of-the-Art Searching

23-24 Feb 2021 - Online webinar

A comprehensive and practical two-day seminar covering the key aspects of patentability and state-of-the-art searching.

Human Factors and Usability Engineering in the Development of Drug Delivery Products

23-24 Feb 2021 - Online webinar

Applying HF and usability to comply with the MDR.

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

Re-energising your Business and Financial Resilience out of the Covid 19 Crisis

24-25 Feb 2021 - Online webinar

Navigating out of the storm - this intensive course aimed at team leaders of all levels will guide you through a review of the impact of the crisis on your whole business - or key areas - and successfully emerging from it.

Freedom-to-Operate Searching

25 Feb 2021 - Online webinar

Get to grips with the fundamentals of FTO searching, understand the scope of a search and analyse the types of rights you will encounter.

Human Factors and Usability Engineering in the Development of Drug Delivery Products

25-26 Feb 2021 - London

Applying HF and usability to comply with the MDR.

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

25-26 Feb 2021 - London

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

Drafting and Negotiating Clinical Trial Agreements

26 Feb 2021 - Online webinar

This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted

Medical Writing for Medical Devices

1-2 Mar 2021 - London

How to produce quality regulatory documents including the clinical evaluation report (CER)

Process Validation with Qualification

2-3 Mar 2021 - Online webinar

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

Patentability and State-of-the-Art Searching

2-3 Mar 2021 - London

A comprehensive and practical two-day seminar covering the key aspects of patentability and state-of-the-art searching.

Drafting International R&D Collaboration and Joint Venture Agreements

3 Mar 2021 - Online webinar

Ensure clear, structured, risk-free collaborative R&D and joint venture agreements for maximum commercial success in one intensive day.

Medical Writing for Medical Devices

3-4 Mar 2021 - Online webinar

How to produce quality regulatory documents including the clinical evaluation report (CER)

Ownership and Control of Intellectual Property Rights

3 Mar 2021 - London
Also on: 4 Mar 2021

In one intensive day learn how to protect and exploit your intellectual property rights for maximum commercial benefit

Managing Remote Teams

4 Mar 2021 - Online webinar

During this programme you will learn how to adapt your management style for remote team working. You will explore ways to communicate and better understand how to monitor and evaluate your team as well as explore the recruitment implications of managing a remote team.

This is a one day interactive online course consisting of 4 x 90 minute sessions.

Freedom-to-Operate Searching

4 Mar 2021 - London

Get to grips with the fundamentals of FTO searching, understand the scope of a search and analyse the types of rights you will encounter.

Process Validation with Qualification

4-5 Mar 2021 - London

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

Drafting International R&D Collaboration and Joint Venture Agreements

4 Mar 2021 - London

Ensure clear, structured, risk-free collaborative R&D and joint venture agreements for maximum commercial success in one intensive day.

Data Integrity and Document Management

4 Mar 2021 - London
Also on: 5 Mar 2021

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

Running Virtual Meetings

5 Mar 2021 - Online webinar

This programme has been designed to help you learn how to prepare and construct a virtual meeting. You will explore the advantages and disadvantages of the various available platforms, understand how to ensure your virtual meeting is engaging and interactive, and practise delivering elements of a virtual meeting in an engaging and interactive manner.

This is an interactive online course consisting of 2 x 90 minutes sessions.

Presenting Virtually

8 Mar 2021 - Online webinar

During this seminar you will learn how to prepare and construct a virtual presentation. You will explore the visual supports available, understand how to use the camera and other tools effectively and acquire tips and hints in terms of dealing with technical issues.

This is an interactive online course consisting of 2 x 90 minutes sessions.

Technical Documentation to Comply with the MDR and IVDR

8-9 Mar 2021 - London

This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.

Negotiating and Drafting IT Contracts

9-10 Mar 2021 - London

A two-day seminar designed to explain what IT contracts are, how and why they work and how to put them in place.

A Practical Approach to Veterinary Vaccine Development and Registration in the EU

9-10 Mar 2021 - Online webinar

This event has been designed to give practical advice and guidance on how to successfully develop market approval in the EU. The programme will take participants through a step-by-step approach to the process and will also provide key guidance on how to maintain MA once achieved.

Business and Contract Law

9-10 Mar 2021 - Online webinar

*A two-day no-nonsense plain English practical course* to get to grips with business and contract law for busy business executives.

Regulatory Strategies for Orphan Drugs

10 Mar 2021 - Online webinar

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

Injectable Drug Delivery

10-11 Mar 2021 - London

Advances in technology for pens, auto-injectors, large volume pumps, patch pumps, needle-free, pre-filled syringes and other parenteral methods.

Technical Documentation to Comply with the MDR and IVDR

10-11 Mar 2021 - Online webinar

This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.

The FDA Drug Approval Process

11-12 Mar 2021 - Online webinar

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

Liabilities, Damages and other Contentious Issues in International Commercial Agreements

11-12 Mar 2021 - Online webinar

Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English law.

Registration of Veterinary Vaccines in the USA and Canada

11 Mar 2021 - Online webinar

This course will cover some of the most complex yet fundamental aspects of veterinary vaccines licensing by USDA and CFIA including the phased submission process as well as the format and content specifications for the required dossier components.

A Practical Approach to Veterinary Vaccine Development and Registration in the EU

11-12 Mar 2021 - London

This event has been designed to give practical advice and guidance on how to successfully develop market approval in the EU. The programme will take participants through a step-by-step approach to the process and will also provide key guidance on how to maintain MA once achieved.

Negotiating and Drafting IT Contracts

11-12 Mar 2021 - Online webinar

A two-day seminar designed to explain what IT contracts are, how and why they work and how to put them in place.

Patent Protection for Software-Related Inventions in Europe and the USA

12 Mar 2021 - Online webinar

An intensive update on patent protection for software-related inventions covering all the major developments in European patent law in particular GUI inventions and 'mixed' inventions with both patentable and non-patentable subject matter.

Registration of Veterinary Vaccines in the USA and Canada

12 Mar 2021 - London

This course will cover some of the most complex yet fundamental aspects of veterinary vaccines licensing by USDA and CFIA including the phased submission process as well as the format and content specifications for the required dossier components.

4-day International Commercial Contracts School, Dubai

15-18 Mar 2021 - London

This specially designed four-day seminar running in *Dubai* has been expressly developed to focus exclusively on the law and regulations governing business and contract law for cross-border contracts.

An Introduction to Pharmaceutical Packaging

15-16 Mar 2021 - London

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

New Medical Device Regulation

15-16 Mar 2021 - London

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

Strategic IP Planning

16-18 Mar 2021 - Online webinar

A step-by-step practical guide to strategic IP planning

Understanding and Managing Competition Law Compliance

16 Mar 2021 - Online webinar

Learn how to navigate competition law and ensure compliance while maximising opportunities for your business

Veterinary Pharmaceutical Submissions in the EU

16-17 Mar 2021 - Online webinar

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.

Business and Contract Law

16-17 Mar 2021 - London

*A two-day no-nonsense plain English practical course* to get to grips with business and contract law for busy business executives.

Regulatory Affairs for Support Staff

16-17 Mar 2021 - London

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

New Medical Device Regulation

17-18 Mar 2021 - Online webinar

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

Advanced Pharmacovigilance

17-19 Mar 2021 - Online webinar

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

An Introduction to Pharmaceutical Packaging

17-18 Mar 2021 - Online webinar

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

Regulatory Strategies for Orphan Drugs

17 Mar 2021 - London

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

Understanding and Managing Competition Law Compliance

17 Mar 2021 - London

Learn how to navigate competition law and ensure compliance while maximising opportunities for your business

Managing and Leading an Effective In-House Legal Department

18-19 Mar 2021 - London

Two practical days to understand current best practice and generate creative, value-added solutions to your management challenges.

Regulatory Affairs for Support Staff

18-19 Mar 2021 - Online webinar

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

Liabilities, Damages and other Contentious Issues in International Commercial Agreements

18-19 Mar 2021 - London

Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English law.

The FDA Drug Approval Process

18-19 Mar 2021 - London

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

Veterinary Pharmaceutical Submissions in the EU

18-19 Mar 2021 - London

Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.

Patent Protection for Software-Related Inventions in Europe and the USA

19 Mar 2021 - London

An intensive update on patent protection for software-related inventions covering all the major developments in European patent law in particular GUI inventions and 'mixed' inventions with both patentable and non-patentable subject matter.

Pharmaceutical Development of ATMPs

22-23 Mar 2021 - Online webinar

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

EPO Oppositions and Appeals - the Case Law and Workshop

22-23 Mar 2021 - Online webinar

*New for 2020!*
Drawing on case law and the experience of the faculty, this seminar considers the present workings of the opposition and appeal procedures at the European Patent Office. It provides an in-depth summary of both background and recent developments at the EPO and explains how these will impact on your day-to-day practice. It will give you the knowledge and skills to navigate this highly technical area.

Pharmaceutical Regulatory Affairs in Africa

22-23 Mar 2021 - Online webinar

Covering the key regions of Algeria, Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Namibia, Nigeria, South Africa, Tanzania, Tunisia, Uganda, Zambia and Zimbabwe.

Risk Management for Clinical Research

22 Mar 2021 - Online webinar

Ensure your clinical trials comply with the latest focus on GCP inspections and develop your own quality risk management principles and procedures

FDA Approval Process for Medical Devices

22-23 Mar 2021 - London

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

Pre-Filled Syringes: End-to-End Processing

23-24 Mar 2021 - Online webinar

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

Biosimilars

23-24 Mar 2021 - Online webinar

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

NEW EVENT!

GCP and Clinical Research Update - Hot Inspection Topics

23 Mar 2021 - Online webinar

This course provides an update on recent changes to ICH GCP R2, EU Clinical Trial Regulation and guidance and will discuss how these changes have been implemented

Strategic IP Planning

23-25 Mar 2021 - London

A step-by-step practical guide to strategic IP planning

Drafting International Commercial Agreements in English

24-26 Mar 2021 - London

The complete guide to drafting and negotiating clear and concise commercial agreements in English. Presented by expert linguists with extensive experience in commercial law.

FDA Approval Process for Medical Devices

24-25 Mar 2021 - Online webinar

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

Advanced Pharmacovigilance

24-26 Mar 2021 - London

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

EPO Oppositions and Appeals - the Case Law and Workshop

24-25 Mar 2021 - London

*New for 2020!*
Drawing on case law and the experience of the faculty, this seminar considers the present workings of the opposition and appeal procedures at the European Patent Office. It provides an in-depth summary of both background and recent developments at the EPO and explains how these will impact on your day-to-day practice. It will give you the knowledge and skills to navigate this highly technical area.

Pharmaceutical Regulatory Affairs in Africa

24-25 Mar 2021 - London

Covering the key regions of Algeria, Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Namibia, Nigeria, South Africa, Tanzania, Tunisia, Uganda, Zambia and Zimbabwe.

Risk Management for Clinical Research

24 Mar 2021 - London

Ensure your clinical trials comply with the latest focus on GCP inspections and develop your own quality risk management principles and procedures

Variations to Marketing Authorisations

25-26 Mar 2021 - Online webinar

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

GCP and Clinical Research Update - Hot Inspection Topics

25 Mar 2021 - London

This course provides an update on recent changes to ICH GCP R2, EU Clinical Trial Regulation and guidance and will discuss how these changes have been implemented

Pre-Filled Syringes: End-to-End Processing

25-26 Mar 2021 - London

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

Pharmaceutical Development of ATMPs

29-30 Mar 2021 - London

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

30 Mar 2021 - Online webinar

This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD)

Biosimilars

30-31 Mar 2021 - London

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

NEW EVENT!

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

31 Mar 2021 - London

This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD)

Pharmaceutical Regulatory Affairs in Asia

7-9 Apr 2021 - Online webinar

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

Variations to Marketing Authorisations

7-8 Apr 2021 - London

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

Filing eCTD Submissions

12 Apr 2021 - London

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

Leadership Skills for Pharmaceutical Professionals

12-13 Apr 2021 - Online webinar

This comprehensive two-day course will introduce you to the core concepts of what makes an excellent leader - in the context of the pharmaceutical industry - and how to apply the different skills of leading your staff and team to maximise results

Filing eCTD Submissions

13 Apr 2021 - Online webinar

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

Biotechnology for the Non-Biotechnologist

14-16 Apr 2021 - Online webinar

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

Pharmaceutical Regulatory Affairs in Asia

14-16 Apr 2021 - London

This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan

Leadership Skills for Pharmaceutical Professionals

14-15 Apr 2021 - London

This comprehensive two-day course will introduce you to the core concepts of what makes an excellent leader - in the context of the pharmaceutical industry - and how to apply the different skills of leading your staff and team to maximise results

Nasal Drug Delivery

15-16 Apr 2021 - London

A comprehensive review of the latest scientific developments, technology advances and regulatory guidance in the field of nasal drug delivery.

Pharmacovigilance Aspects of Licensing Agreements

15 Apr 2021 - Online webinar

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

Dealing With Difficult People

16 Apr 2021 - Online webinar

During this event you will discover why people are difficult, learn to recognise classic profiles of difficult people, pre-empt challenging situations and avoid escalation, enhance your own attributes and develop coping strategies.

This is a one day interactive online course consisting of 4 x 90 minutes sessions.

Pharmacovigilance Aspects of Licensing Agreements

16 Apr 2021 - London

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

EU Pharmaceutical Regulations & Strategy

19-20 Apr 2021 - Online webinar

This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations

Cyber Security for Medical Devices

19-20 Apr 2021 - London

Advanced Regulatory Affairs for Medical Devices

20-21 Apr 2021 - Online webinar

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

Effective Technology Transfer

20-21 Apr 2021 - Online webinar

The ‘how to’ of technology transfer across the product lifecycle

Introduction to Veterinary Pharmacovigilance

20-21 Apr 2021 - Online webinar

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.

*INCLUDES: Interactive workshop and discussion sessions*

EU Clinical Trial Regulation: Overview and Implementation

20-21 Apr 2021 - London

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU

Cyber Security for Medical Devices

21-22 Apr 2021 - Online webinar

Biotechnology for the Non-Biotechnologist

21-23 Apr 2021 - London

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

EU Pharmaceutical Regulations & Strategy

21-22 Apr 2021 - London

This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations

EU Clinical Trial Regulation: Overview and Implementation

22-23 Apr 2021 - Online webinar

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU

Advanced Regulatory Affairs for Medical Devices

22-23 Apr 2021 - London

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

Effective Technology Transfer

22-23 Apr 2021 - London

The ‘how to’ of technology transfer across the product lifecycle

Introduction to Veterinary Pharmacovigilance

22-23 Apr 2021 - London

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.

*INCLUDES: Interactive workshop and discussion sessions*

An Essential Overview of Pharmacovigilance

26 Apr 2021 - Online webinar

A practical guide to understanding the role of pharmacovigilance.

Managing Vendor/CRO/CMO Oversight

26-27 Apr 2021 - Online webinar

Learn how to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource

Drug/Device and Device/Drug Combinations in the EU and USA

26-27 Apr 2021 - London

Practical guidance on borderline Issues and combination products

Practical Implementation of GCP in Veterinary Field Studies

27-28 Apr 2021 - Online webinar

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

An Essential Overview of Pharmacovigilance

27 Apr 2021 - London

A practical guide to understanding the role of pharmacovigilance.

The Role and Skills of a Valuable HR Assistant

28 Apr 2021 - Online webinar

Practical applied learning for HR professionals – a one-day intensive briefing on best practice and employment law requirements for the effective HR assistant .

Medical Device Software: Complying with the MDR & FDA Regulations

28-30 Apr 2021 - Online webinar

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

Drug/Device and Device/Drug Combinations in the EU and USA

28-29 Apr 2021 - Online webinar

Practical guidance on borderline Issues and combination products

Managing Vendor/CRO/CMO Oversight

28-29 Apr 2021 - London

Learn how to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource

Practical Implementation of GCP in Veterinary Field Studies

29-30 Apr 2021 - London

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

The Role and Skills of a Valuable HR Assistant

29 Apr 2021 - London

Practical applied learning for HR professionals – a one-day intensive briefing on best practice and employment law requirements for the effective HR assistant .

Signal Detection and Regulatory Expectations

4-5 May 2021 - Online webinar

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

Development of Combination Products: Critical Interactions

5-6 May 2021 - Online webinar

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

The New EU Animal Health Legislation for Veterinary Medicinal Products

5-6 May 2021 - Online webinar

The programme will offer a comprehensive introduction to the new EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.

*INCLUDES: Interactive discussion sessions*

Medical Device Software: Complying with the MDR & FDA Regulations

5-7 May 2021 - London

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

Signal Detection and Regulatory Expectations

6-7 May 2021 - London

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

Drafting Effective Pharmaceutical Patents

6-7 May 2021 - London

*New for 2020!*
Drafting successful pharmaceutical patents is complex and there are many pitfalls and risks to be aware of. You need to ensure you’re maximising the protection for your, and your client’s, pharmaceutical inventions thorough both primary and secondary pharmaceutical patents.

An Essential Overview of the Pharmaceutical and Biotech Industries

6 May 2021 - London
Also on: 7 May 2021

This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.

Medical Device Studies: Clinical Evidence

10-11 May 2021 - Online webinar

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

Influencing, Persuading and Negotiating Skills for International Lawyers

10-11 May 2021 - Online webinar

A two-day workshop for those who need to achieve results through personal influence.
*BOOK EARLY – limited places available!*

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

11-12 May 2021 - Online webinar

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

Periodic Safety Update Reports for Veterinary Medicinal Products

11-12 May 2021 - Online webinar

Including requirements for regions including the EEA, USA, Canada and Australia and an update on the implications of Brexit

*NEW EVENT!*

Development of Combination Products: Critical Interactions

11-12 May 2021 - London

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

The New EU Animal Health Legislation for Veterinary Medicinal Products

11-12 May 2021 - London

The programme will offer a comprehensive introduction to the new EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.

*INCLUDES: Interactive discussion sessions*

Pharmacovigilance QMS & Inspection Preparation

11-12 May 2021 - London

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

An Introduction to the Medical Device Regulation

12-14 May 2021 - Online webinar

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

Litigation-Proofing and Proving your Patent Claims

12 May 2021 - Online webinar

This seminar provides a comprehensive overview of the principles of patent claim interpretation in the USA, UK and Germany.

The Pharma Mini MBA

12-14 May 2021 - Online webinar

A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries

Influencing, Persuading and Negotiating Skills for International Lawyers

12-13 May 2021 - London

A two-day workshop for those who need to achieve results through personal influence.
*BOOK EARLY – limited places available!*

Developing High Performance HR Business Partner and Consulting Skills

13-14 May 2021 - Online webinar

Achieve excellence as an HR business partner and enhance your ability to deliver a positive impact and support across the whole business.

How to Avoid Common Pitfalls in Combined EU/US Patent Applications

13-14 May 2021 - Online webinar

This seminar addresses the parallel, but substantially different, rules for drafting and prosecuting patents required by the Examiners and Appeal Boards of the EPO and USPTO.

Pharmacovigilance QMS & Inspection Preparation

13-14 May 2021 - Online webinar

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

An Essential Overview of the Medical Device Industry

13 May 2021 - Online webinar

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

Clean Communication

13 May 2021 - Online webinar

Throughout this programme you will learn how to use clean communication to convey your meaning and enhance your relationships, explore how to build rapport with others and understand how to clarify what others want of you. You'll acquire tips and hints for motivating others and practise your use of language to inspire action in others.

This is an interactive online course consisting of 2 x 90 minutes sessions.

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

13-14 May 2021 - London

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

Periodic Safety Update Reports for Veterinary Medicinal Products

13-14 May 2021 - London

Including requirements for regions including the EEA, USA, Canada and Australia and an update on the implications of Brexit

*NEW EVENT!*

Mental Resilience in a Home-working Environment

14 May 2021 - Online webinar

This programme will help you consider why a positive attitude is the key to home working and encourage you to develop disciplines for maximising the effectiveness of home working. You'll learn how to overcome issues of loneliness and isolation, develop coping strategies for maintaining self-confidence and self-worth and learn how to achieve and maintain a work/life balance when working remotely.

This is an interactive online course consisting of 2 x 90 minutes sessions.

An Essential Overview of the Medical Device Industry

14 May 2021 - London

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

Clinical Quality Management Systems

17-18 May 2021 - Online webinar

A two-day course that will ensure you comply with new regulatory requirements.

Medical Device Studies: Clinical Evidence

17-18 May 2021 - London

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

Successful Medical Writing

17-19 May 2021 - London

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

Biological Evaluation of Medical Devices

18-19 May 2021 - London

Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.

*Includes:* Interactive workshops and discussion sessions

The Art of European Claim Drafting

18-19 May 2021 - London

This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.

The Role of an Effective HR Advisor

18-19 May 2021 - London

This practical two-day programme is a must-attend event for any newly promoted or aspiring HR advisors, as well as those looking for a refresher.

An Introduction to the Medical Device Regulation

19-21 May 2021 - London

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

Litigation-Proofing and Proving your Patent Claims

19 May 2021 - London

This seminar provides a comprehensive overview of the principles of patent claim interpretation in the USA, UK and Germany.

The Pharma Mini MBA

19-21 May 2021 - London

A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries

The Role of an Effective HR Advisor

20-21 May 2021 - Online webinar

This practical two-day programme is a must-attend event for any newly promoted or aspiring HR advisors, as well as those looking for a refresher.

Drafting International Intellectual Property Agreements

20 May 2021 - Online webinar

Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements.

The Art of European Claim Drafting

20-21 May 2021 - Online webinar

This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.

How to Avoid Common Pitfalls in Combined EU/US Patent Applications

20-21 May 2021 - London

This seminar addresses the parallel, but substantially different, rules for drafting and prosecuting patents required by the Examiners and Appeal Boards of the EPO and USPTO.

Drafting International Intellectual Property Agreements

21 May 2021 - London

Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements.

Successful Medical Writing

24-26 May 2021 - Online webinar

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

Clinical Quality Management Systems

24-25 May 2021 - London

A two-day course that will ensure you comply with new regulatory requirements.

An Introduction to the Design and Development of Medical Devices

24-25 May 2021 - Online webinar

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

Re-energising your Business and Financial Resilience out of the Covid 19 Crisis

24-25 May 2021 - Online webinar

Navigating out of the storm - this intensive course aimed at team leaders of all levels will guide you through a review of the impact of the crisis on your whole business - or key areas - and successfully emerging from it.

Employment Law in Practice from Recruitment to Termination

25-26 May 2021 - Online webinar

Raise your knowledge of the latest employment law and legislation and learn how to deal practically with the numerous issues an employer regularly faces.

An Introduction to the Design and Development of Medical Devices

26-27 May 2021 - London

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

Employment Law in Practice from Recruitment to Termination

27-28 May 2021 - London

Raise your knowledge of the latest employment law and legislation and learn how to deal practically with the numerous issues an employer regularly faces.

Common Technical Document

2-3 Jun 2021 - Online webinar

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

Working Through Veterinary Drug Development in the EU and USA

7-10 Jun 2021 - London

This practical four-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.

Positive Persuading and Influencing Skills for Pharma Professionals

7-8 Jun 2021 - London

This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

8-9 Jun 2021 - Online webinar

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

Reviewing and Negotiating Technology Transfer and Licensing Agreements

8-9 Jun 2021 - Online webinar

Providing key legal and commercial skills essential to secure a successful agreement.

*FULLY UPDATED PROGRAMME*

How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace

8 Jun 2021 - Online webinar

Raise your knowledge of the latest laws and best practice for avoiding and, where necessary, managing these sensitive issues within the workplace.

*NEW EVENT for 2020*

Recruiting a High Performance Global Workforce Within the Law

8-9 Jun 2021 - London

*New for 2020!*
An intensive and practical two-day programme for HR professionals and line managers.

Raise your knowledge of the latest laws and best practice for recruiting overseas nationals and learn how to integrate them effectively into your current workforce.

Drafting Commercial Contracts for the Pharmaceutical Industry

9-11 Jun 2021 - London

A three-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors.

Positive Persuading and Influencing Skills for Pharma Professionals

9-10 Jun 2021 - Online webinar

This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business

The Patent Administrator

9 Jun 2021 - Online webinar

This course will give you a comprehensive introduction to the role of the patent administrator

Common Technical Document

9-10 Jun 2021 - London

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace

9 Jun 2021 - London

Raise your knowledge of the latest laws and best practice for avoiding and, where necessary, managing these sensitive issues within the workplace.

*NEW EVENT for 2020*

Recruiting a High Performance Global Workforce Within the Law

10-11 Jun 2021 - Online webinar

*New for 2020!*
An intensive and practical two-day programme for HR professionals and line managers.

Raise your knowledge of the latest laws and best practice for recruiting overseas nationals and learn how to integrate them effectively into your current workforce.

The Role and Responsibilities of the Contracts Manager

10-11 Jun 2021 - Online webinar

Getting from contract agreement to successful contract completion.

Proactively manage your contracts by applying a logical and systematic approach to enable you to anticipate risks and resolve problems before they become critical.

*NEW EVENT!*

Drafting and Negotiating Clinical Trial Agreements

10 Jun 2021 - Online webinar

This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted

Drafting and Negotiating International Agency and Distribution Agreements

10-11 Jun 2021 - Online webinar

Proactively manage the legal and commercial considerations essential for securing a successful international agreement.
*INCLUDES: Practical and interactive exercises*

US Patent Practice

10-11 Jun 2021 - Online webinar

What all European patent attorneys need to know - an intensive and highly interactive two-day seminar including discussions on US patent law and strategies and tactics for patent prosecution at the US Patent Office

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

10-11 Jun 2021 - London

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

The Patent Administrator

10 Jun 2021 - London

This course will give you a comprehensive introduction to the role of the patent administrator

Drafting and Negotiating Clinical Trial Agreements

11 Jun 2021 - London

This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted

Business and Contract Law

14-15 Jun 2021 - Online webinar

*A two-day no-nonsense plain English practical course* to get to grips with business and contract law for busy business executives.

Registration of Animal Feed Additives in the EU

14-15 Jun 2021 - London

This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.

The Role of the Senior HR Manager

14-15 Jun 2021 - London

This programme has been specifically designed for those HR professionals who operate at, or aspire to operate at, a senior level within their businesses.

3-day Drafting Commercial Contracts

15-17 Jun 2021 - Online webinar

A practical, interactive three-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training in the key drafting skills.

Reviewing and Negotiating Technology Transfer and Licensing Agreements

15-16 Jun 2021 - London

Providing key legal and commercial skills essential to secure a successful agreement.

*FULLY UPDATED PROGRAMME*

Project Management for Pharma Professionals

15-16 Jun 2021 - London

The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health

*Includes:* Interactive workshop sessions

The Role and Responsibilities of the Contracts Manager

15-16 Jun 2021 - London

Getting from contract agreement to successful contract completion.

Proactively manage your contracts by applying a logical and systematic approach to enable you to anticipate risks and resolve problems before they become critical.

*NEW EVENT!*

The Role of the Senior HR Manager

16-17 Jun 2021 - Online webinar

This programme has been specifically designed for those HR professionals who operate at, or aspire to operate at, a senior level within their businesses.

Registration of Animal Feed Additives in the EU

16-17 Jun 2021 - Online webinar

This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.

Advanced Drafting Techniques for Successful EPO Patent Applications

16 Jun 2021 - Online webinar

Many patent applications and patents are lost before the EPO, either before Opposition Divisions or before Appeal due to incorrect original drafting, and added subject matter is a recurrent problem. Learn advanced drafting techniques for successful EPO patent applications.

*INCLUDES: Interactive workshop sessions and details of the latest case law and its implications*

Effective Defence of EPO Patent Applications

17 Jun 2021 - Online webinar

Clarity in drafting patent applications has always been a serious issue. The purpose of the seminar is to teach delegates the essentials of clarity, and the most effective use of the problem-solution approach, giving delegates an edge over other parties.

*INCLUDES: Interactive workshop sessions and details of the latest case law and its implications*

Project Management for Pharma Professionals

17-18 Jun 2021 - Online webinar

The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health

*Includes:* Interactive workshop sessions

IP Due Diligence & Freedom to Operate in Practice

17 Jun 2021 - Online webinar

This intensive one-day course will give you many insights into the best practice of organising and conducting an efficient and thorough IP due diligence project.

Drafting and Negotiating International Agency and Distribution Agreements

17-18 Jun 2021 - London

Proactively manage the legal and commercial considerations essential for securing a successful international agreement.
*INCLUDES: Practical and interactive exercises*

US Patent Practice

17-18 Jun 2021 - London

What all European patent attorneys need to know - an intensive and highly interactive two-day seminar including discussions on US patent law and strategies and tactics for patent prosecution at the US Patent Office

Business and Contract Law

17-18 Jun 2021 - London

*A two-day no-nonsense plain English practical course* to get to grips with business and contract law for busy business executives.

Pharmacovigilance

21-23 Jun 2021 - London

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

Advanced Veterinary Pharmacovigilance

21-22 Jun 2021 - London

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

The Mini MBA for In-house Lawyers

22-25 Jun 2021 - London

Business, commercial, financial and leadership skills to manage and develop a sound and strategically effective in-house legal department

3-day Drafting Commercial Contracts

22-24 Jun 2021 - London

A practical, interactive three-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training in the key drafting skills.

Formal Requirements of the European Patent System

22-23 Jun 2021 - London

A two-day seminar for administrative staff in the patent profession on how to competently prepare an application for filing before the EPO.

*INCLUDES: Practical and interactive exercises*

Dry Powder Inhalers

23-24 Jun 2021 - London

A comprehensive overview of DPIs including market trends, treatments formulation, regulation and device design

*FULLY UPDATED PROGRAMME*

Advanced Veterinary Pharmacovigilance

23-24 Jun 2021 - Online webinar

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

Advanced Drafting Techniques for Successful EPO Patent Applications

23 Jun 2021 - London

Many patent applications and patents are lost before the EPO, either before Opposition Divisions or before Appeal due to incorrect original drafting, and added subject matter is a recurrent problem. Learn advanced drafting techniques for successful EPO patent applications.

*INCLUDES: Interactive workshop sessions and details of the latest case law and its implications*

Formal Requirements of the European Patent System

24-25 Jun 2021 - Online webinar

A two-day seminar for administrative staff in the patent profession on how to competently prepare an application for filing before the EPO.

*INCLUDES: Practical and interactive exercises*

Effective Defence of EPO Patent Applications

24 Jun 2021 - London

Clarity in drafting patent applications has always been a serious issue. The purpose of the seminar is to teach delegates the essentials of clarity, and the most effective use of the problem-solution approach, giving delegates an edge over other parties.

*INCLUDES: Interactive workshop sessions and details of the latest case law and its implications*

IP Due Diligence & Freedom to Operate in Practice

24 Jun 2021 - London

This intensive one-day course will give you many insights into the best practice of organising and conducting an efficient and thorough IP due diligence project.

Pharmaceutical Regulatory Affairs in the Middle East

28-29 Jun 2021 - Online webinar

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

A Practical Guide to Writing Risk Management Plans (RMPs)

28 Jun 2021 - Online webinar

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

How to Write Effective SOPs

28 Jun 2021 - Online webinar

An essential course for ensuring compliance with regulatory requirements which will be of particular relevance for pharmacovigilance, regulatory affairs, clinical research/operations, GMP, QA and document management functions.

A Practical Guide to Producing and Maintaining the PSMF

29 Jun 2021 - Online webinar

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

Improving Processes and CAPA (Corrective and Preventative Action)

29 Jun 2021 - Online webinar

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.

Medical Device Regulations in the Middle East and North Africa

30 Jun-1 Jul 2021 - Online webinar

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.

*Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen*

A Practical Guide to Writing Risk Management Plans (RMPs)

30 Jun 2021 - London

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

How to Write Effective SOPs

30 Jun 2021 - London

An essential course for ensuring compliance with regulatory requirements which will be of particular relevance for pharmacovigilance, regulatory affairs, clinical research/operations, GMP, QA and document management functions.

A Practical Guide to Producing and Maintaining the PSMF

1 Jul 2021 - London

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

Improving Processes and CAPA (Corrective and Preventative Action)

1 Jul 2021 - London

This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.

The Medical Device Summer School - From Concept to CE Marking

5-9 Jul 2021 - London

*A practical five-day course with interactive workshops - now in its 17th successful year!*

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

Clinical Trial Regulatory Requirements

5-6 Jul 2021 - Online webinar

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements.

Pharmaceutical Regulatory Affairs in the Middle East

5-6 Jul 2021 - London

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

Stability Testing of Pharmaceuticals and Biopharmaceuticals

6-7 Jul 2021 - Online webinar

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

Medical Device Regulations in the Middle East and North Africa

7-8 Jul 2021 - London

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.

*Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen*

Clinical Trial Regulatory Requirements

7-8 Jul 2021 - London

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements.

Stability Testing of Pharmaceuticals and Biopharmaceuticals

8-9 Jul 2021 - London

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

Re-energising your Business and Financial Resilience out of the Covid 19 Crisis

24-25 Aug 2021 - Online webinar

Navigating out of the storm - this intensive course aimed at team leaders of all levels will guide you through a review of the impact of the crisis on your whole business - or key areas - and successfully emerging from it.

Liabilities, Damages and other Contentious Issues in International Commercial Agreements

13-14 Sep 2021 - Online webinar

Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English law.

Managing Remote Teams

13 Sep 2021 - Online webinar

During this programme you will learn how to adapt your management style for remote team working. You will explore ways to communicate and better understand how to monitor and evaluate your team as well as explore the recruitment implications of managing a remote team.

This is a one day interactive online course consisting of 4 x 90 minute sessions.

EPO Oppositions and Appeals - the Case Law and Workshop

13-14 Sep 2021 - London

*New for 2020!*
Drawing on case law and the experience of the faculty, this seminar considers the present workings of the opposition and appeal procedures at the European Patent Office. It provides an in-depth summary of both background and recent developments at the EPO and explains how these will impact on your day-to-day practice. It will give you the knowledge and skills to navigate this highly technical area.

FDA Approval Process for Medical Devices

13-14 Sep 2021 - London

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

Metered Dose Inhaler (MDI) Technology

13-14 Sep 2021 - London

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

Running Virtual Meetings

14 Sep 2021 - Online webinar

This programme has been designed to help you learn how to prepare and construct a virtual meeting. You will explore the advantages and disadvantages of the various available platforms, understand how to ensure your virtual meeting is engaging and interactive, and practise delivering elements of a virtual meeting in an engaging and interactive manner.

This is an interactive online course consisting of 2 x 90 minutes sessions.

EPO Oppositions and Appeals - the Case Law and Workshop

15-16 Sep 2021 - Online webinar

*New for 2020!*
Drawing on case law and the experience of the faculty, this seminar considers the present workings of the opposition and appeal procedures at the European Patent Office. It provides an in-depth summary of both background and recent developments at the EPO and explains how these will impact on your day-to-day practice. It will give you the knowledge and skills to navigate this highly technical area.

FDA Approval Process for Medical Devices

15-16 Sep 2021 - Online webinar

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

Metered Dose Inhaler (MDI) Technology

15-16 Sep 2021 - Online webinar

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

Presenting Virtually

15 Sep 2021 - Online webinar

During this seminar you will learn how to prepare and construct a virtual presentation. You will explore the visual supports available, understand how to use the camera and other tools effectively and acquire tips and hints in terms of dealing with technical issues.

This is an interactive online course consisting of 2 x 90 minutes sessions.

Liabilities, Damages and other Contentious Issues in International Commercial Agreements

15-16 Sep 2021 - London

Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English law.

Drafting International R&D Collaboration and Joint Venture Agreements

16 Sep 2021 - Online webinar
Also on: 17 Sep 2021

Ensure clear, structured, risk-free collaborative R&D and joint venture agreements for maximum commercial success in one intensive day.

The FDA Drug Approval Process

20-21 Sep 2021 - Online webinar

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

Human Factors and Usability Engineering in the Development of Drug Delivery Products

20-21 Sep 2021 - London

Applying HF and usability to comply with the MDR.

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

20-21 Sep 2021 - London

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

Strategic IP Planning

21-23 Sep 2021 - Online webinar

A step-by-step practical guide to strategic IP planning

Process Validation with Qualification

21-22 Sep 2021 - Online webinar

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

Risk Management for Clinical Research

21 Sep 2021 - London

Ensure your clinical trials comply with the latest focus on GCP inspections and develop your own quality risk management principles and procedures

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

22-23 Sep 2021 - Online webinar

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

Advanced Pharmacovigilance

22-24 Sep 2021 - Online webinar

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

Regulatory Strategies for Orphan Drugs

22 Sep 2021 - Online webinar

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

Human Factors and Usability Engineering in the Development of Drug Delivery Products

22-23 Sep 2021 - Online webinar

Applying HF and usability to comply with the MDR.

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

Avoiding Pitfalls in Patent/Know-How Licences and R&D Collaborations

22 Sep 2021 - Online webinar

Analyse and discuss the key aspects of patent/know-how licences and R&D collaborations, assessing the areas where things can and do go wrong.

GCP and Clinical Research Update - Hot Inspection Topics

22 Sep 2021 - London

This course provides an update on recent changes to ICH GCP R2, EU Clinical Trial Regulation and guidance and will discuss how these changes have been implemented

Risk Management for Clinical Research

23 Sep 2021 - Online webinar

Ensure your clinical trials comply with the latest focus on GCP inspections and develop your own quality risk management principles and procedures

Process Validation with Qualification

23-24 Sep 2021 - London

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

Avoiding Pitfalls in Patent/Know-How Licences and R&D Collaborations

23 Sep 2021 - London

Analyse and discuss the key aspects of patent/know-how licences and R&D collaborations, assessing the areas where things can and do go wrong.

Effective Technical Writing & Editing

23 Sep 2021 - London
Also on: 24 Sep 2021

Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.

Patent Protection for Software-Related Inventions in Europe and the USA

24 Sep 2021 - Online webinar

An intensive update on patent protection for software-related inventions covering all the major developments in European patent law in particular GUI inventions and 'mixed' inventions with both patentable and non-patentable subject matter.

GCP and Clinical Research Update - Hot Inspection Topics

24 Sep 2021 - Online webinar

This course provides an update on recent changes to ICH GCP R2, EU Clinical Trial Regulation and guidance and will discuss how these changes have been implemented

Regulatory Affairs for Support Staff

27-28 Sep 2021 - Online webinar

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

The FDA Drug Approval Process

27-28 Sep 2021 - London

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

Advanced Regulatory Affairs for Medical Devices

28-29 Sep 2021 - Online webinar

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

An Introduction to Pharmaceutical Packaging

28-29 Sep 2021 - Online webinar

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

Strategic IP Planning

28-30 Sep 2021 - London

A step-by-step practical guide to strategic IP planning

Leadership Skills for Pharmaceutical Professionals

28-29 Sep 2021 - London

This comprehensive two-day course will introduce you to the core concepts of what makes an excellent leader - in the context of the pharmaceutical industry - and how to apply the different skills of leading your staff and team to maximise results

Biotechnology for the Non-Biotechnologist

29 Sep-1 Oct 2021 - Online webinar

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

Regulatory Strategies for Orphan Drugs

29 Sep 2021 - London

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

Advanced Pharmacovigilance

29 Sep-1 Oct 2021 - London

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

Regulatory Affairs for Support Staff

29-30 Sep 2021 - London

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

Understanding and Managing Competition Law Compliance

30 Sep 2021 - Online webinar

Learn how to navigate competition law and ensure compliance while maximising opportunities for your business

Leadership Skills for Pharmaceutical Professionals

30 Sep-1 Oct 2021 - Online webinar

This comprehensive two-day course will introduce you to the core concepts of what makes an excellent leader - in the context of the pharmaceutical industry - and how to apply the different skills of leading your staff and team to maximise results

An Introduction to Pharmaceutical Packaging

30 Sep-1 Oct 2021 - London

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

Advanced Regulatory Affairs for Medical Devices

30 Sep-1 Oct 2021 - London

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

Patent Protection for Software-Related Inventions in Europe and the USA

1 Oct 2021 - London

An intensive update on patent protection for software-related inventions covering all the major developments in European patent law in particular GUI inventions and 'mixed' inventions with both patentable and non-patentable subject matter.

Understanding and Managing Competition Law Compliance

1 Oct 2021 - London

Learn how to navigate competition law and ensure compliance while maximising opportunities for your business

5-day International Commercial Contracts School

3-7 Oct 2021 - London

This specialist five-day seminar has been expressly developed to focus exclusively on the law and regulations governing business and contract law for cross-border contracts.

Pharmaceutical Development of ATMPs

4-5 Oct 2021 - Online webinar

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

An Essential Overview of Pharmacovigilance

4 Oct 2021 - Online webinar

A practical guide to understanding the role of pharmacovigilance.

Successful Medical Writing

4-6 Oct 2021 - Online webinar

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

Data Integrity and Document Management

4 Oct 2021 - Online webinar

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

Effective Technology Transfer

5-6 Oct 2021 - Online webinar

The ‘how to’ of technology transfer across the product lifecycle

Biosimilars

5-6 Oct 2021 - Online webinar

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

NEW EVENT!

Patentability and State-of-the-Art Searching

5-6 Oct 2021 - Online webinar

A comprehensive and practical two-day seminar covering the key aspects of patentability and state-of-the-art searching.

An Essential Overview of Pharmacovigilance

5 Oct 2021 - London

A practical guide to understanding the role of pharmacovigilance.

Data Integrity and Document Management

5 Oct 2021 - London

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

Negotiating and Drafting IT Contracts

6-7 Oct 2021 - Online webinar

A two-day seminar designed to explain what IT contracts are, how and why they work and how to put them in place.

The Role and Skills of a Valuable HR Assistant

6 Oct 2021 - Online webinar

Practical applied learning for HR professionals – a one-day intensive briefing on best practice and employment law requirements for the effective HR assistant .

Medical Device Regulation in the Eurasian Union, Russia and the CIS

6-7 Oct 2021 - Online webinar

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

Biotechnology for the Non-Biotechnologist

6-8 Oct 2021 - London

An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.

The Role of an Effective HR Advisor

7-8 Oct 2021 - Online webinar

This practical two-day programme is a must-attend event for any newly promoted or aspiring HR advisors, as well as those looking for a refresher.

Managing and Leading an Effective In-House Legal Department

7-8 Oct 2021 - London

Two practical days to understand current best practice and generate creative, value-added solutions to your management challenges.

Freedom-to-Operate Searching

7 Oct 2021 - Online webinar

Get to grips with the fundamentals of FTO searching, understand the scope of a search and analyse the types of rights you will encounter.

Variations to Marketing Authorisations

7-8 Oct 2021 - Online webinar

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

Managing Vendor/CRO/CMO Oversight

7-8 Oct 2021 - Online webinar

Learn how to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource

Effective Technology Transfer

7-8 Oct 2021 - London

The ‘how to’ of technology transfer across the product lifecycle

Pharmacovigilance Aspects of Licensing Agreements

7 Oct 2021 - London
Also on: 8 Oct 2021

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

5-day International Commercial Contracts School

10-14 Oct 2021 - Online webinar

This specialist five-day seminar has been expressly developed to focus exclusively on the law and regulations governing business and contract law for cross-border contracts.

Pharmaceutical Development of ATMPs

11-12 Oct 2021 - London

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

Successful Medical Writing

11-13 Oct 2021 - London

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

Managing Vendor/CRO/CMO Oversight

11-12 Oct 2021 - London

Learn how to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource

An Introduction to the Design and Development of Medical Devices

11-12 Oct 2021 - London

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

New Medical Device Regulation

12-13 Oct 2021 - Online webinar

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

Introduction to Veterinary Pharmacovigilance

12-13 Oct 2021 - Online webinar

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.

*INCLUDES: Interactive workshop and discussion sessions*

Biosimilars

12-13 Oct 2021 - London

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

NEW EVENT!

Patentability and State-of-the-Art Searching

12-13 Oct 2021 - London

A comprehensive and practical two-day seminar covering the key aspects of patentability and state-of-the-art searching.

Employment Law in Practice from Recruitment to Termination

12-13 Oct 2021 - London

Raise your knowledge of the latest employment law and legislation and learn how to deal practically with the numerous issues an employer regularly faces.

An Introduction to the Design and Development of Medical Devices

13-14 Oct 2021 - Online webinar

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

Medical Device Regulation in the Eurasian Union, Russia and the CIS

13-14 Oct 2021 - London

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

Negotiating and Drafting IT Contracts

13-14 Oct 2021 - London

A two-day seminar designed to explain what IT contracts are, how and why they work and how to put them in place.

The Role and Skills of a Valuable HR Assistant

13 Oct 2021 - London

Practical applied learning for HR professionals – a one-day intensive briefing on best practice and employment law requirements for the effective HR assistant .

Employment Law in Practice from Recruitment to Termination

14-15 Oct 2021 - Online webinar

Raise your knowledge of the latest employment law and legislation and learn how to deal practically with the numerous issues an employer regularly faces.

Freedom-to-Operate Searching

14 Oct 2021 - London

Get to grips with the fundamentals of FTO searching, understand the scope of a search and analyse the types of rights you will encounter.

The Role of an Effective HR Advisor

14-15 Oct 2021 - London

This practical two-day programme is a must-attend event for any newly promoted or aspiring HR advisors, as well as those looking for a refresher.

Variations to Marketing Authorisations

14-15 Oct 2021 - London

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

Introduction to Veterinary Pharmacovigilance

14-15 Oct 2021 - London

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.

*INCLUDES: Interactive workshop and discussion sessions*

New Medical Device Regulation

14-15 Oct 2021 - London

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

An Essential Overview of the Medical Device Industry

18 Oct 2021 - Online webinar

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

Filing eCTD Submissions

18 Oct 2021 - London

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.

EU Clinical Trial Regulation: Overview and Implementation

18-19 Oct 2021 - Online webinar

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU

EU Pharmaceutical Regulations & Strategy

18-19 Oct 2021 - London

This course will provide an up-to-date overview of the European pharmaceutical regulatory environment, procedures and obligations

Medical Writing for Medical Devices

19-20 Oct 2021 - Online webinar

How to produce quality regulatory documents including the clinical evaluation report (CER)

Periodic Safety Update Reports for Veterinary Medicinal Products

19-20 Oct 2021 - Online webinar

Including requirements for regions including the EEA, USA, Canada and Australia and an update on the implications of Brexit

*NEW EVENT!*

An Essential Overview of the Medical Device Industry

19 Oct 2021 - London

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

Filing eCTD Submissions

19 Oct 2021 - Online webinar

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.