Presented by
Management Forum
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
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:
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 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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
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
Until 30 May
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
Until 15 Sep
* 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.
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
Denmark
France
Italy
Netherlands
Switzerland
Belgium
Ireland
Austria
Germany
Spain
Sweden
United States of America
2 days
Typical duration
Pricing from:
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: