The New Clinical Trial Regulation: Overview and Impact

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

11-12 Apr 2019

& 7-8 Oct 2019

GBP 1,499
EUR 2,099
USD 2,338

Book now

Why you should attend

The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC). The new regulation was originally due to come into effect in 2016, however implementation has been delayed until the new portal and clinical trial database have been completed and audited. Key aims of the new regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial database and portal. Guidelines for enacting the new regulation are also being prepared in a number of areas including inspection, investigational medicinal product and trial documentation etc.

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.The course will highlight the most important of these key requirements and changes and how these are likely to impact on trials now and in the future for biopharmaceutical companies, CROs and study sites.

Key topics to be covered

  • The NEW Clinical Trial Regulation
  • The implications of having a regulation instead of a Directive
  • Clinical trial transparency
  • Clinical trial authorisation process
  • Co-sponsorship concept
  • Safety reporting
  • Trials in emergency situations
  • Trials with authorized medicinal products
  • Risk-based considerations
  • Non-EU sponsors
  • Requirements for managing investigational medicinal products
  • Pharmacovigilance
  • Regulatory inspection

Who should attend?

This course is ideal for anyone requiring an update on the new Clinical Trial Regulation. The course is relevant for those working in regulatory, clinical research, clinical operations, project management, pharmacovigilance, quality assurance (GCP auditors), vendor/CRO professionals, study sites and other professionals in pharmaceutical and biotechnology organisations conducting trials with drugs, biologics or combination products.

It will also be of interest to those departments who liaise/support clinical trial personnel, and all other professionals who want to know more about this important new Regulation.


Introduction and Objectives

Background to the EU clinical research regulation in Europe
  • The development of European clinical trial legislation and the current framework of clinical trial regulations in Europe
  • Overview of the current Clinical Trial Directive requirements
  • What are the main problems of working with the Clinical Trial Directive?
  • Directive vs Regulation – what is the difference
  • The new EU Clinical Trial Regulation and how this will replace the EU Clinical Trials Directive
Changes in the new EU Clinical Trial Regulation
  • Overview of the major new requirements of the Clinical Trial Regulation
    • Risk based evaluations
    • Non-EU sponsors
    • Transparency
    • Trials in emergency situations
    • Co-sponsorship concept
linical trial regulatory authorisation and ethical approval
  • How the introduction of the new clinical trial regulation will significantly change clinical trial approval in the EU
  • Understand the components of the new clinical trial authorization process: RMS, CMS, portal and database, single dossier
  • The new clinical trial authorisation process
  • Substantial modifications
linical trial transparency requirements in the EU
  • The new EMA policy of 2015 on publication of clinical data entered into force
  • Public consultation on how the transparency rules of the European Clinical Trial Regulation will be applied in the new clinical trial database
nvestigational medicinal product/auxiliary product guidelines
  • GMP requirements
  • The key requirements
  • Requirements for labelling and packaging
Pharmacovigilance and adverse event reporting – key safety changes
  • Adverse event reporting – requirements and definitions
  • Safety reporting requirements
Considerations for regulatory inspection – review of the delegated act
  • How to prepare for inspection in the EU
  • What to expect from inspectors?

Summary and close


Laura Brown

Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.

Book now

11-12 Apr 2019
11-12 Apr 2019 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
7-8 Oct 2019
7-8 Oct 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Ablynx
  • Alcon-Novartis
  • Baxter R&D sprl
  • CSL Behring UK Ltd
  • Incyte Europe
  • LEO Pharma
  • Leo Pharma A S
  • Mediscribe Consulting Ltd
  • Smith & Nephew
  • USGI Medical

Good overview of the new regulations, presented in an interesting and interactive way. Some of the practical case studies weren't that relevant for me, but hopefully benefitted others.

Helen Watts, Regulatory Affairs Manager, CSL Behring UK Ltd

I like everything about Management forum Courses, hence my attendance for few years now, and I respect Laura's way of presentation, her patience, kindness and we always learn a lot from her. I do look for any opportunity to attend courses which are applicable to my day to day work as I found them useful. Any luck you may run again the All day event like you did couple of years ago, for free where few courses were taking place at the same time and where we could jump from one to another ...?Thanks for all

Hadjira Rezzoug, Senior RA Associate, Alcon-Novartis

Lots of info, good content, pleasant speaker and very knowledgeable.

Francine Galibert, , Incyte Europe