Our latest COVID-19 information/status - including self-paced online learning from our training partner Falconbury

Calendar

September 2020 training courses

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

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

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

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.

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

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

This specialist five-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.

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

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.

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.

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

Strategic IP Planning

22-24 Sep 2020

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

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.

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.

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

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

Practical guidance on borderline Issues and combination products

This prestigious annual ‘must-attend’ event has been designed specifically for senior patent administrators. It provides an ideal opportunity to learn about any developments that affect you and your role and make sure you are up to date on best practice and are working as efficiently as possible.

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.

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

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

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.

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

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.

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

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.

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

October 2020 training courses

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

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

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.

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

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.

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.

A practical guide to understanding the role of pharmacovigilance.

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

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

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

NEW EVENT!

Biosimilars

6-7 Oct 2020

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

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.

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.

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

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.

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

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

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

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.

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

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

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

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

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.

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

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

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

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.

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.

This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.

November 2020 training courses

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

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

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.

An essential annual update for inhalation professionals.

Inhaled Drug Delivery

3-4 Nov 2020

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

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

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

NEW EVENT!

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.

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.

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

This practical and interactive two-day programme will ensure you understand where your organisation is exposed and how you can successfully protect against risk.

This annual update, specifically designed for senior trade mark and design administrators, includes the latest updates from WIPO with discussion on the Madrid and Hague systems and a review of the differences between US, EU and UK practice and what to do about them.

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

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

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

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

FULLY UPDATED PROGRAMME

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

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

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.

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

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 Pharma Mini MBA

11-13 Nov 2020

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

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

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

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

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

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.

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

NEW COURSE!

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.

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

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

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

This two-day programme will give you a detailed understanding of the PCT mechanism beyond the basics with practical tips and advice on how to make the most efficient use of ePCT.

Advanced PCT Formalities

19-20 Nov 2020

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

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

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

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

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

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!

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

December 2020 training courses

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

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

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.

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

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

US Patent Practice

3-4 Dec 2020

Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China – now in its tenth successful year.

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.

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.

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.

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

Pharmacovigilance

7-9 Dec 2020

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

This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them

January 2021 training courses

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.

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

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.

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.

February 2021 training courses

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

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

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

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.

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

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

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.

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

March 2021 training courses

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.

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

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

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

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.

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

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.

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

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

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

Injectable Drug Delivery

10-11 Mar 2021

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.

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

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

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.

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.

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.

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

Strategic IP Planning

16-18 Mar 2021

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

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.

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.

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.

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.

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

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.

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

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.

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

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

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.

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

NEW EVENT!

Biosimilars

23-24 Mar 2021

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

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

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.

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.

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)

April 2021 training courses

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

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

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

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

Nasal Drug Delivery

15-16 Apr 2021

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

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

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

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

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

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

A practical guide to understanding the role of pharmacovigilance.

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

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.

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

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

May 2021 training courses

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

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

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

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.

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

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

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

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.

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

NEW EVENT!

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.

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

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 Pharma Mini MBA

12-14 May 2021

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

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.

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

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.

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

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

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.

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

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

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.

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

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

June 2021 training courses

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

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

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

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

FULLY UPDATED PROGRAMME

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

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.

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

NEW COURSE!

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

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.

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

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

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

US Patent Practice

10-11 Jun 2021

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.

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

Business and Contract Law

15-16 Jun 2021

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

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

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

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!

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

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

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.

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

Pharmacovigilance

21-23 Jun 2021

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

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

FULLY UPDATED PROGRAMME

Dry Powder Inhalers

23-24 Jun 2021

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

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

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

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

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.

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.

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.

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

July 2021 training courses

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.

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.

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.

September 2021 training courses

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

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.

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.

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

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

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

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

Strategic IP Planning

21-23 Sep 2021

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.

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

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

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.

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.

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.

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

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

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.

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

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.

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

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.

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

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

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

October 2021 training courses

This specialist five-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.

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

A practical guide to understanding the role of pharmacovigilance.

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 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.

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

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

NEW EVENT!

Biosimilars

5-6 Oct 2021

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

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

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

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.

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.

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

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

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.

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

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

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.

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

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

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

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.

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

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

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

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

NEW EVENT!

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

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

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.

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.

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

This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.

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

November 2021 training courses

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

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.

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

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.

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.

This practical and interactive two-day programme will ensure you understand where your organisation is exposed and how you can successfully protect against risk.

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

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

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

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

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

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

FULLY UPDATED PROGRAMME

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

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.

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

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 Pharma Mini MBA

10-12 Nov 2021

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

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

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

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

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

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

NEW COURSE!

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

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

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

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

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

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.

A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.

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

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

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.

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!

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

December 2021 training courses

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

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.

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

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

US Patent Practice

1-2 Dec 2021

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

Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China – now in its tenth successful year.

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.

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.

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.

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

Pharmacovigilance

6-8 Dec 2021

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.

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

This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them