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EU (European Union) Clinical Trial Regulation 536/2014: Overview and Implementation Training Course

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing texts for carrying out clinical trials in the EU

★★★★★ "This was a very detailed and great overview of the CTR and I would recommend following this course i... more"

23-24 May 2022 + 2 more dates

Need help?  Enrol now

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

Course overview

The new EU Clinical Trial Regulation (536/2014) replaces the European Clinical Trials Directive (2001/20/EC) in 2022. 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 CTIS (Clinical Trial Information System).

This course will provide an essential understanding to help with compliance with the new Regulation and key 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 how these are likely to impact on trials for biopharmaceutical companies, vendors 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
  • Understand the new CTIS
  • Discuss the Clinical Trial Regulation implementation documents
  • Understand the new EU clinical trial authorisation process, including considerations for the UK

Key topics to be covered include:

  • New Clinical Trials Information System
  • 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.

Enrol now

The EU Clinical Trial Regulation 536/2014: Overview and Implementation course will cover:

Background to the EU Clinical Trial Regulation

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

Overview of the key requirements and changes

  • Including:
    • Roles and responsibilities
    • Non-EU sponsors
    • Transparency
    • Co-sponsorship

Harmonisation templates

  • Investigator Curriculum Vitae
  • Declaration of interest template
  • Site suitability
  • Informed consent and patient recruitment procedure
  • Compensation for trial participants

Clinical Trial Regulatory Authorisation

  • The significant changes in clinical trial approval in the EU
  • The new clinical trial authorisation process
  • Substantial modifications
  • Notices
  • End of study reports

The new CTIS (Clinical Trial Information System)

  • What is CTIS?
  • How to use CTIS
  • CTIS training

Clinical Trial Ethical Approval and Informed Consent

  • Ethical approval considerations under the Regulation
  • Informed consent changes under the regulation

EU Clinical Trial Regulation Documents

  • Serious breaches
  • Risk-proportionate approaches in clinical trials
  • Summaries of clinical trial results for laypersons
  • Q&A document

Manufacturing

  • GMP requirements
  • Key requirements for IMPs and auxiliary medicinal products
  • Labelling and packaging

Safety reporting

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

Clinical Trials in Children

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

Inspection preparation under the new regulation

  • GCP and GMP inspection guidelines
  • How to prepare for inspection in the EU under the new EU Clinical Trial Requirements
  • TMF guideline documentation considerations for inspection

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Laura Brown

Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and QA Consultant, Course Director for the MSc Regulatory Affairs, TOPRA. She has more than 25 years’ experience in the pharmaceutical industry including clinical trial regulations.  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 536/2014: Overview and Implementation Live online/Classroom training

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

23-24 May 2022

Live online

09:30-16:30 UK (London) (UTC+01)
10:30-17:30 Paris (UTC+02)
04:30-11:30 New York (UTC-04)
Course code 11604

  • GBP 1,299
  • EUR 1,859
  • USD 2,098

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4-5 Jul 2022

Classroom
Rembrandt Hotel
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

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20-21 Oct 2022

Live online

09:30-16:30 UK (London) (UTC+01)
10:30-17:30 Paris (UTC+02)
04:30-11:30 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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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Reviews of IPI's EU Clinical Trial Regulation 536/2014: Overview and Implementation training course


Very nice webinar which gave a good overview of the CTR and the CTIS portal. I liked the parts where the part 1 and part 2 was presented as I think this is not straightforward to understand. Also, I like the small quizzes that were done.

Feb 21 2022

Ellen Due Horup
Compliance Manager, ALK-Abelló

Feb 21 2022

Very thorough and covered a lot of topics

Christine Woodward
Pharmacovigilance Manager, Drug Safety Solutions Limited

Apr 22 2021

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.

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

United Kingdom

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

Denmark

  • ALK
  • ALK-Abelló
  • ALK-Abello A/S
  • 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

France

  • JWC
  • STALLERGENES
  • stallergennes greer

Italy

  • Alfasigma Sp.A.
  • Chiesi Farmaceutici SPA
  • Menarini Ricerche

Netherlands

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

Switzerland

  • CUTISS AG
  • Incyte Europe
  • Takeda Pharmaceuticals International AG

Belgium

  • Ablynx
  • Baxter R&D sprl

Ireland

  • Aspen Pharma Trading Limited
  • Theravance Biopharma Ireland Limited

Austria

  • Octapharma Pharmazeutika Produktionsges.m.b.H.

Germany

  • Life Molecular Imaging GmbH

Spain

  • FAES FARMA

Sweden

  • Link Medical AB

United States of America

  • USGI Medical

Enrol now

Run EU Clinical Trial Regulation 536/2014: Overview and Implementation Live online/Classroom for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training expert Aleksandra Beer to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, 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