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
20-21 Oct 2022
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.
Laura Brown (More...)
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
NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
20-21 Oct 2022
20-21 Oct 2022
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 15 Sep*
* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.