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Management Forum

EU (European Union) Clinical Trial Regulation 536/2014: Overview and Implementation Experience In-house Training

This course will provide an update on the experience of working to the regulation since Go-live, to help your implementation and compliance including transferring clinical trials from the directive to the regulation.

★★★★★ "This was a very detailed and great overview of the CTR and I would recommend following this course i... more (11)"

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Format: Bespoke training
CPD: 12 hours for your records (depending on your requirements)
Certificate of completion

Course overview

The CTR, which became applicable on 31st January 2022, is directly effective in all EU Member States and introduced the biggest change to the legal framework surrounding clinical trials since the Clinical Trials Directive was implemented. The CTR has already had a global impact as all interventional trials that take place even partially in an EU Member State need to comply with its regulatory requirements, at every stage of the trial life cycle.

This course will provide an essential understanding of the new Regulation and key associated implementing acts and other texts for carrying out clinical trials in the EU. It 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 have impacted so far on trials for biopharmaceutical companies, vendors and study sites since going live in 2022.

This will include explaining how the regulation has harmonised 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).

Benefits of attending:

Gain an overview of the Clinical Trial Regulation and changes for trials in the EU
Understand the new Clinical Trials Information system (CTIS) and experience so far
Share experiences of implementing the Clinical Trials Regulation
Discuss the Clinical Trial Regulation implementation documents
Understand the EU clinical trial authorisation process and experience

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Key topics to be covered include:

Clinical Trials Information System
Clinical trial authorisation process
Safety reporting
Requirements for managing investigational medicinal products
Clinical trials conducted on children
Regulatory inspection

Who should attend?

This event is ideal for anyone requiring an understanding and update on the EU Clinical Trials 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.

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

Laura is a good speaker, keep the attention. The content was in line with the expectation.

May 23 2022

Margherita Lerro Italy
Study Manager, Menarini Ricerche

Feb 21 2022

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.

Ellen Due Horup Denmark
Compliance Manager, ALK-Abelló

Feb 21 2022

Very thorough and covered a lot of topics

Christine Woodward United Kingdom
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 Netherlands
Regulatory Affairs Liaison, Galapagos

Apr 22 2021

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

Ban Eshqi United Kingdom
Scientific Affairs Pharmacist, CHEMIDEX PHARMA LTD

Oct 7 2019

The small group allowed for good interaction between participants.

Jacques Wodelet France
Quality Manager , JWC

Apr 11 2019

Professional, engaging, informative, useful.

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

Apr 11 2019

I think this course has been very good.

Sidse Schjøtz Denmark
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 United Kingdom
Regulatory Affairs Manager, CSL Behring UK Ltd

Jan 27 2017

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

Francine Galibert Switzerland
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 United Kingdom
Senior RA Associate, Alcon-Novartis

Denmark Denmark