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

7-8 Oct 2019

& 23-24 Apr 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). 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.

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 directive
Gain an update on the implementation of the Clinical Trial Regulation Delegated Acts and other implementation documents
Understand the new clinical trial authorisation process for regulatory approval and ethical approval

Key topics to be covered include:

  • 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 authorised 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 with/support clinical trial personnel, and all other professionals who want to know more about this important new regulation.


Background to the EU clinical research regulation in Europe

  • The development of European clinical trial legislation
  • Eudralex 10 – the framework of clinical trial regulations in Europe
  • Overview of the current Clinical Trials Directive requirements
  • What are the main problems of working 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 – Trials in emergency situations – Co-sponsorship concept

Review and discuss key EU Clinical Trial Regulation Eudralex 10 documents

  • Serious breaches
  • Risk proportionate approaches in clinical trials
  • Summaries of clinical trial results for laypersons – ICH GCP (R2)
  • Recommendations for the trial master file
  • Question and Answers document – Regulation (EU) 536/2014

Clinical trial regulatory authorisation and ethical approval

  • The significant changes in clinical trial approval in the EU
  • Understand the components of the new clinical trial authorisation process: – RMS, CMS, portal and database, single dossier
  • 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)

Ethical considerations for clinical trials conducted with minors

  • 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 – review of key EU clinical trial regulation inspection documents
  • GCP inspection guidelines (updated in 2017 and 2018)
  • Implementing regulation for GCP inspection procedures
  • Delegated Regulation (EU) 2017/1569 specifying principles and guidelines for GMP inspections
    How to prepare for inspection in the EU


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

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
23-24 Apr 2020
23-24 Apr 2020 Venue not yet confirmed
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.

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Previous customers include...

  • Ablynx
  • Alcon-Novartis
  • ALK
  • Aspen Pharma Trading Limited
  • Baxter R&D sprl
  • CSL Behring UK Ltd
  • Incyte Europe
  • LEO Pharma
  • Leo Pharma A S
  • Mediscribe Consulting Ltd
  • PRA Health Sciences
  • Smith & Nephew
  • USGI Medical

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

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

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

Francine Galibert, , Incyte Europe