Presented by
Management Forum

EU Clinical Trial Regulation: Overview and Implementation

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

10-11 Jan 2022 + 3 more dates

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  • Format: Classroom, Live online
  • CPD: 12 hours for your records
  • Certificate of completion

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. Once the electronic portal and database are fully functional and the European Commission has given its approval, it will take six months to become applicable. Guidelines for enacting the new Regulation have also been 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 programme 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
  • Discuss the Clinical Trial Regulation delegated acts and other implementation documents
  • Understand 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.

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The EU Clinical Trial Regulation: Overview and Implementation course will cover:

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
  • Q&A 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

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Laura Brown

Dr Laura Brown is an independent QA and training consultant and Senior Lecturer of the MSc in Clinical Research, School of Pharmacy, University of Cardiff. Laura has many years’ experience in the pharmaceutical industry, having worked for several leading companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has worked as a clinical research manager, audit director and head of a training department. Laura is an international expert on regulatory requirements in clinical research and was Chair of the Institute of Clinical Research GCP Forum for over six years. She writes regularly on clinical research regulatory requirements and is author of several articles on the EU Clinical Trial Regulation, ‘The Planning of International Drug Development’ in the Clinical Research Manual and has written a chapter in International Pharmaceutical Product Registration.

More details

Book EU Clinical Trial Regulation: Overview and Implementation Classroom/Live online training

10-11 Jan 2022

Classroom
London venue TBC

00:00-00:00 UK (London)
Course code 11410

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 06 Dec

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

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7-8 Apr 2022

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 11604

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 03 Mar

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4-5 Jul 2022

Classroom
London venue TBC

00:00-00:00 UK (London)
Course code 11886

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 30 May

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

View basket 

20-21 Oct 2022

Live online

00:00-00:00 UK (London) (UTC+01)
01:00-01:00 Paris (UTC+02)
19:00-19:00 New York (UTC-04)
Course code 11731

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 15 Sep

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Reviews of IPI's EU Clinical Trial Regulation: Overview and Implementation training course


This was a very detailed and great overview of the CTR and I would recommend following this course if this new CTR has impact on your work or your company.

Apr 22 2021

Leyla Nematollahi
Regulatory Affairs Liaison, Galapagos

Apr 22 2021

I think overall the webinar very good, instructive and informative.

Ban Eshqi
Scientific Affairs Pharmacist, CHEMIDEX PHARMA LTD

Oct 7 2019

The small group allowed for good interaction between participants.

Jacques Wodelet
Quality Manager , JWC

Apr 11 2019

Professional, engaging, informative, useful.

James O'Donoghue
Director Medical Writing, PRA Health Sciences

Apr 11 2019

I think this course has been very good.

Sidse Schjøtz
Complinace Manager, ALK

Jan 27 2017

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

Jan 27 2017

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

Francine Galibert
Incyte Europe

Jan 27 2017

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

UK

  • Alcon-Novartis
  • Biomarin
  • Blue Reg Pharma Consult
  • CHEMIDEX PHARMA LTD
  • CSL Behring UK Ltd
  • Mediscribe Consulting Ltd
  • Oxford Biomedica
  • PRA Health Sciences
  • Smith & Nephew

Denmark

  • ALK
  • H. Lundbeck A/S
  • LEO Pharma
  • Leo Pharma A S
  • Lundbeck
  • Novo Nordisk A/S
  • Novo Nordisk A/S.
  • Novo Nordisk A/S. Company Member

Netherlands

  • Abbott Healthcare Products B.V.
  • Galapagos
  • Merus NV

Belgium

  • Ablynx
  • Baxter R&D sprl

Ireland

  • Aspen Pharma Trading Limited
  • Theravance Biopharma Ireland Limited

Italy

  • Alfasigma Sp.A.
  • Chiesi Farmaceutici SPA

Switzerland

  • Incyte Europe
  • Takeda Pharmaceuticals International AG

Austria

  • Octapharma Pharmazeutika Produktionsges.m.b.H.

France

  • JWC

Germany

  • Life Molecular Imaging GmbH

Spain

  • FAES FARMA

United States of America

  • USGI Medical

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy