Presented by
Management Forum
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
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:
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.
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.
10-11 Jan 2022
Classroom
London venue TBC
00:00-00:00 UK (London)
Course code 11410
Until 06 Dec
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
Until 03 Mar
4-5 Jul 2022
Classroom
London venue TBC
00:00-00:00 UK (London)
Course code 11886
Until 30 May
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
Until 15 Sep
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
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