Calendar

June 2018

Hear the latest information from our expert speaker panel to help you understand the changes that are required and ensure you are up to date with Brexit!

Brand new course for 2018

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 meeting 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

July 2018

This leading project management course will provide you with a thorough understanding of project management skills, including both technical and interpersonal skills

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.

Gain a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Global roll out of the dossier to ROW regions including LATAM, ASEAN, MENA and CIS territories also covered.

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

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

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the 2017 update.

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.

September 2018

General introduction and important information on FDA Procedures requirements for marketing authorizations and recent developments affecting the drug approval process in the US

Book by 26 Jul to save
£200 / €280 / $312

This course will provide examples of common issues/pitfalls and will enable you to improve your audit report writing skills, and therefore, give you more confidence in creating effective reports via which your audit outputs can be communicated to your stakeholders.

Book by 26 Jul to save
£100 / €140 / $156

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

Book by 23 Jul to save
£200 / €280 / $312

Contract Law 2018 – this is an ideal seminar for those wishing to increase their understanding of the fundamentals of contract law, and understand and improve the contracts they negotiate and manage

Contract Law Update

19 Sep 2018

Book by 23 Jul to save
£100 / €140 / $156

Compare the requirements of ISO 13485 and ISO 9001, understand the role and responsibilities of quality management. Consider the relationship between ISO 13485 and ISO 14971, Application to Risk Management to Medical Devices

Book by 15 Aug to save
£200 / €280 / $312

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.

Book by 10 Aug to save
£100 / €140 / $156

This programme highlight the different perspectives of academic parties, commercial parties and institutional funding bodies and explain some of the legal issues affecting R&D agreements.

Book by 23 Jul to save
£100 / €140 / $156

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

Book by 10 Aug to save
£100 / €140 / $156

This two day course which has been designed specifically for those working in a support staff role provides an introduction to Pharmaceutical Regulatory Affairs and the basics of drug development.

Book by 26 Jul to save
£200 / €280 / $312

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

Book by 26 Jul to save
£100 / €140 / $156

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

Book by 26 Jul to save
£100 / €140 / $156

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

Book by 15 Aug to save
£100 / €140 / $156

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

Book by 15 Aug to save
£300 / €420 / $468

This two-day workshop is for those new to negotiations or for those who wish to refresh and/or enhance their existing negotiation skills.

Book by 15 Aug to save
£200 / €280 / $312

A step by step practical guide to Strategic IP Planning.

Strategic IP Planning

25-27 Sep 2018

Book by 10 Aug to save
£300 / €420 / $468

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.

Book by 15 Aug to save
£200 / €280 / $312

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

Book by 26 Jul to save
£100 / €140 / $156

Biotechnology for the Non Biotechnologist, ideal for non-Scientists and Scientists who need to understand the basic theory, principles, techniques, and potential of biotechnology

Book by 10 Aug to save
£300 / €420 / $468

This course provides a good basic grounding and appreciation of what is required for the packaging of pharmaceutical and healthcare products. It is ideal for newcomers and a good refresher for those with more experience

Book by 15 Aug to save
£200 / €280 / $312

This 17th 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, to make sure you are up to date on best-practice and are working as efficiently as possible.

Book by 14 Aug to save
£200 / €280 / $312

October 2018

Pharmaceutical Regulatory Affairs in Africa including South Africa, Algeria ,Botswana, Ethiopia, Ghana, Kenya, Malawi, Morocco, Mozambique, Nigeria, Namibia, South Africa, Tanzania, Tunisia, Uganda, Zambia, Zimbabwe

Book by 17 Aug to save
£200 / €280 / $312

Advanced Veterinary Pharmacovigilance – the purpose of this course is to provide a comprehensive, yet practical assessment of the main requirements to ensure a compliant reporting Company.

Book by 17 Aug to save
£200 / €280 / $312

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

Book by 17 Aug to save
£200 / €280 / $312

Advances in wearable drug delivery

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

Book by 10 Aug to save
£100 / €140 / $156

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.

Communicate, influence and motivate to enhance internal and external relationships and to help improve both yours and the business performance.

Book by 13 Aug to save
£100 / €140 / $156

Understand the importance of accuracy and attention to detail in day-to-day work

Book by 13 Aug to save
£100 / €140 / $156

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.

Book by 15 Aug to save
£200 / €280 / $312

A new comprehensive and practical two day seminar covering Patentability and State-of-the-art Searching

Book by 14 Aug to save
£200 / €280 / $312

Understanding the background, defining terms and objectives; fundamentals of FTO search scope, methods for searching for claimed features, using basic legal status tools to assist valuation, and understanding and reporting the results from an FTO perspective.

Book by 14 Aug to save
£100 / €140 / $156

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

Book by 15 Aug to save
£100 / €140 / $156

Pharmacovigilance has become one of the most demanding aspects to both understand and comply with. This course will provide a concise overview of the pharmacovigilance function and the regulatory requirements.

This interactive one day course will provide an introduction to mindfulness and encourage new ways of thinking and working, as well as help you relate to stress and problems in a different way.

Book by 15 Aug to save
£100 / €140 / $156

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.

Book by 15 Aug to save
£300 / €420 / $468

This meeting 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.

Gain a comprehensive understanding of the EU and FDA Process Validation Guidance, how to establish a Process Validation Programme, understand the link between quality by design and process validation, apply relevant tools for process validation including risk assessment

Book by 17 Aug to save
£200 / €280 / $312

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.

Book by 24 Aug to save
£200 / €280 / $312

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.

Book by 17 Aug to save
£100 / €140 / $156

Practical Guidance on Borderline Issues and Combination Products

Book by 24 Aug to save
£200 / €280 / $312

There are fundamental changes to pharmacovigilance practice described in these guidelines which follow the EU guidelines, issued and implemented in June 2012. This intensive two-day course will look at the various new topics and their practical application.

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

Dealing with difficult people. This meeting will cover discovering why people are difficult, recognising classic profiles of difficult people, pre-empting challenging situations and avoid escalation, enhancing your own attributes, developing your copying strategies

Conflict is an inevitable part of life. This interactive seminar will help provide added skills for when conflict has arisen and there is a need to build confidence and de-escalate the confrontation

A practical interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements

Book by 11 Sep to save
£200 / €280 / $312

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

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 GCP as outlined in the two guidelines on safety and efficacy produced by FEDESA and CVMP.

November 2018

Interactive course ideal for anyone with responsibility for planning or delivering training in the Pharma, Device or Animal Health Industries (including GXP and SOP training to comply with EU and FDA inspection requirements).

This annual conference will include case studies, regulatory updates, latest therapies and technology innovations in two information packed days

Inhaled Drug Delivery

1-2 Nov 2018

This 3-day accelerated management programme will provide you with practical management tools to apply in the workplace, as well as giving a real taste of an MBA course with pharma case studies from business schools.

The Pharma Mini MBA

5-7 Nov 2018

Understand the impact of IP on pharmaceutical regulatory strategy

Brand new course for 2018

A comprehensive overview of the requirements for drug/device and device/drug combination products in the EU and USA

Proactively manage the legal and commercial considerations essential for securing a successful international agreement

Book by 11 Sep to save
£200 / €280 / $312

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.

Licensing agreements are frequently used by commercial entities, public or quasi-public bodies for the development of new business prospects and cross-border expansion.

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.

Senior Trade Mark & Design Administrators, speakers from WIPO discussing the Madrid and Hague systems, from OHIM discussing the guidelines, also presentation about differences between US and EU practice and what to do about them.

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

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 ‘how to’ of technology transfer across the product lifecycle

New for 2018

Book by 5 Oct to save
£200 / €280 / $312

Some of the topics to be covered at this meeting include an overview of the legal/policy landscape as it affects the terms of CTAs, clause-by-clause review, legal clauses, review of a University’s CTA

This seminar has been designed specifically for those who are involved in gathering clinical evidence required for medical devices and in-vitro diagnostic products.

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.

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.

Creating a team that speaks and acts with one vision in the pharma/device/animal health industries

A 3-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors

An Introduction to Medical Device Software: Regulations & Requirements to include EU & 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

Effectively communicate, negotiate, influence and persuade to build your personal brand and positively impact personal and business performance in this intensive two-day development programme

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

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 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.

Brochure will be available shortly.

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

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

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

28-29 Nov 2018

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 most efficient use of ePCT

Advanced PCT Formalities

29-30 Nov 2018

A two- day seminar for Administrative Staff in the Patent Profession on how to competently prepare an application for filing before the EPO

December 2018

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

Pharmacovigilance

3-5 Dec 2018

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

US Patent Practice, What European patent attorneys need to know. A 2-day highly interactive seminar

US Patent Practice

4-5 Dec 2018

This meeting 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

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

Gain a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Global roll out of the dossier to ROW regions including LATAM, ASEAN, MENA and CIS territories also covered.

This leading project management course will provide you with a thorough understanding of project management skills, including both technical and interpersonal skills

Two day meeting on Regulation Update on Animal Feed and Feed Additives in the EU, USA and China, annual conference now in its 6th successful year.

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

New course for 2018

January 2019

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.

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

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the 2017 update.

An insight into the FDA thinking of which products qualify for a Risk Evaluation and Mitigation Strategies (REMS), the different categories of REMS, their introduction and maintenance and the reporting assessments on the REMS.

February 2019

A new comprehensive and practical two day seminar covering Patentability and State-of-the-art Searching

Understanding the background, defining terms and objectives; fundamentals of FTO search scope, methods for searching for claimed features, using basic legal status tools to assist valuation, and understanding and reporting the results from an FTO perspective.

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

Book by 26 Jul to save
£100 / €140 / $156

This programme highlight the different perspectives of academic parties, commercial parties and institutional funding bodies and explain some of the legal issues affecting R&D agreements.

A practical interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements

Contract Law 2018 – this is an ideal seminar for those wishing to increase their understanding of the fundamentals of contract law, and understand and improve the contracts they negotiate and manage

Contract Law Update

28 Feb 2019

March 2019

This course will provide examples of common issues/pitfalls and will enable you to improve your audit report writing skills, and therefore, give you more confidence in creating effective reports via which your audit outputs can be communicated to your stakeholders.

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

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.

Book by 15 Aug to save
£200 / €280 / $312

Gain a comprehensive understanding of the EU and FDA Process Validation Guidance, how to establish a Process Validation Programme, understand the link between quality by design and process validation, apply relevant tools for process validation including risk assessment

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

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

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

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 Veterinary Pharmacovigilance – the purpose of this course is to provide a comprehensive, yet practical assessment of the main requirements to ensure a compliant reporting Company.

This two day course which has been designed specifically for those working in a support staff role provides an introduction to Pharmaceutical Regulatory Affairs and the basics of drug development.

Practical Guidance on Borderline Issues and Combination Products

A step by step practical guide to Strategic IP Planning.

Strategic IP Planning

19-21 Mar 2019

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

This course provides a good basic grounding and appreciation of what is required for the packaging of pharmaceutical and healthcare products. It is ideal for newcomers and a good refresher for those with more experience

Book by 15 Aug to save
£200 / €280 / $312

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.

Pre-Filled Syringes

20 Mar 2019

General introduction and important information on FDA Procedures requirements for marketing authorizations and recent developments affecting the drug approval process in the US

The essential conference for pharmaceutical and medical device professionals covering advances in technology for pens, auto-injectors, large volume pumps, patch pumps, needle-free, pre-filled syringes and other parenteral methods – plus a regulatory update

Injectable Drug Delivery

21-22 Mar 2019

This course will be of maximum benefit to those 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

Book by 15 Aug to save
£100 / €140 / $156

This seminar will enable you to meet the new international GCP ICH GCP E6 standard to enable the acceptance of clinical trial data by the regulatory authorities internationally including the European Union, Japan, the United States, Canada and Switzerland.

April 2019

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

Communicate, influence and motivate to enhance internal and external relationships and to help improve both yours and the business performance.

Understand the importance of accuracy and attention to detail in day-to-day work

Book by 13 Aug to save
£100 / €140 / $156

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

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.

Biotechnology for the Non Biotechnologist, ideal for non-Scientists and Scientists who need to understand the basic theory, principles, techniques, and potential of biotechnology

This conference gives a comprehensive review within the field of nasal drug delivery while reviewing interesting new data and innovative technologies.

Nasal Drug Delivery

11-12 Apr 2019

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

This interactive one day course will provide an introduction to mindfulness and encourage new ways of thinking and working, as well as help you relate to stress and problems in a different way.

May 2019

An Introduction to Medical Device Software: Regulations & Requirements to include EU & FDA Guidance and Risk Management

Understand the impact of IP on pharmaceutical regulatory strategy

Brand new course for 2018

This 3-day accelerated management programme will provide you with practical management tools to apply in the workplace, as well as giving a real taste of an MBA course with pharma case studies from business schools.

The Pharma Mini MBA

13-15 May 2019

Some of the topics to be covered at this meeting include an overview of the legal/policy landscape as it affects the terms of CTAs, clause-by-clause review, legal clauses, review of a University’s CTA

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

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

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.

Brochure will be available shortly.

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

New for 2018

Book by 5 Oct to save
£200 / €280 / $312

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.

June 2019

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

New course for 2018

Effectively communicate, negotiate, influence and persuade to build your personal brand and positively impact personal and business performance in this intensive two-day development programme

US Patent Practice, What European patent attorneys need to know. A 2-day highly interactive seminar

US Patent Practice

13-14 Jun 2019

This seminar will provide you with an essential overview of the key areas of pharmaceutical regulatory affairs in the Middle East.

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 of 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

20-21 Jun 2019

September 2019

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

This programme highlight the different perspectives of academic parties, commercial parties and institutional funding bodies and explain some of the legal issues affecting R&D agreements.

A step by step practical guide to Strategic IP Planning.

Strategic IP Planning

24-26 Sep 2019

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.

Contract Law 2018 – this is an ideal seminar for those wishing to increase their understanding of the fundamentals of contract law, and understand and improve the contracts they negotiate and manage

Contract Law Update

25 Sep 2019

October 2019

A practical interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements

November 2019

Effectively communicate, negotiate, influence and persuade to build your personal brand and positively impact personal and business performance in this intensive two-day development programme

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

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

28-29 Nov 2019

December 2019

US Patent Practice, What European patent attorneys need to know. A 2-day highly interactive seminar

US Patent Practice

5-6 Dec 2019