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

23-24 Apr 2020

& 19-20 Oct 2020

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

Book now

Course overview

The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC). 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 products and trial documentation. 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 for biopharmaceutical companies, CROs and study sites.

Benefits of attending:

  • Gain an overview of the Clinical Trial Regulation and changes for trials in the EU
  • Review how the new Regulation differs from the previous Clinical Trials Directive
  • Be updated on the Clinical Trial Regulation Delegated Acts and other implementation documents
  • Discuss the new EU clinical trial authorisation process, including considerations for the UK

Key topics to be covered include:

  • Implications of having a regulation instead of a directive
  • Clinical trial transparency
  • Clinical trial authorisation process
  • Co-sponsorship
  • Safety reporting
  • Trials with authorised medicinal products
  • Risk-based considerations
  • Non-EU sponsors
  • Requirements for managing investigational medicinal products
  • Clinical trials conducted on children
  • Regulatory inspection

Who should attend?

This event is ideal for anyone requiring an update on the EU Clinical Trial Regulation (536/2014) 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 with/support clinical trial personnel, and all other professionals who want to know more about this important new Regulation.


Background to the EU Clinical Trial Regulation (536/2014)

  • The development of European clinical trial legislation
  • The framework of clinical trial regulations in Europe
  • Overview of the current Clinical Trials Directive requirements
  • Problems with the Clinical Trials Directive
  • Directive vs regulation – what are the main differences?

Changes in the new EU Clinical Trial Regulation

Overview of the major new requirements of the Regulation including:

- Risk-based evaluations
- Non-EU sponsors
- Transparency
- Informed consent
- Co-sponsorship

EU Clinical Trial Regulation documents

  • Serious breaches
  • Risk proportionate approaches in clinical trials
  • Summaries of clinical trial results for laypersons
  • ICH GCP (R2)
  • New requirements for the trial master file
  • Question and Answers document

Clinical trial regulatory authorisation and ethical approval

  • The significant changes in clinical trial approval in the EU The new clinical trial authorisation process
  • Substantial modifications
  • Investigational medicinal product/auxiliary product guidelines
  • GMP requirements
  • Key requirements for IMPs and AMPs (auxiliary medicinal products)
  • Requirements for labelling and packaging

Pharmacovigilance and adverse event reporting

  • Adverse event reporting – requirements and definitions
  • Safety reporting requirements
  • RSI (reference safety information)

Considerations for clinical trials conducted with minors

  • EU guidance for running clinical trials on children
  • Assent and consent
  • Key differences and requirements for running clinical trials on children compared to adults

Considerations for regulatory inspection

  • GCP and GMP inspection guidelines
  • How to prepare for inspection under the new EU clinical trial requirements


Laura Brown

Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), 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 and regulatory requirements in clinical trials in the pharmaceutical industry. She has worked in senior positions for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including data protection and data integrity in clinical trials. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues in clinical trials

Book now

23-24 Apr 2020
23-24 Apr 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
19-20 Oct 2020
19-20 Oct 2020 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...

  • Abbott Healthcare Products B.V.
  • Ablynx
  • Alcon-Novartis
  • Alfasigma Sp.A.
  • ALK
  • Aspen Pharma Trading Limited
  • Baxter R&D sprl
  • Biomarin
  • BioMarin (UK) Ltd
  • CSL Behring UK Ltd
  • Incyte Europe
  • JWC
  • LEO Pharma
  • Leo Pharma A S
  • Lundbeck
  • Mediscribe Consulting Ltd
  • Oxford BioMedica
  • PRA Health Sciences
  • Smith & Nephew
  • USGI Medical

I think this course has been very good.

Sidse Schjøtz, Compliance Manager, ALK

Professional, engaging, informative, useful.

James O'Donoghue, Director Medical Writing, PRA Health Sciences

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