The EU Clinical
Trial Regulation (CTR) will replace the EU Clinical Trial Directive (CTD). The
implementation should start end 2018. The EU CTR is supposed to address
shortcomings of the EU CTD and promote attractiveness of EU for conducting trials.
The EU CTR will be presented with an overview of the latest updates from EMA
and the impact of the changes for a sponsor and CRO. Some results will be
provided from the User Acceptance Tests performed so far on the EMA portal.
In France, a
status will be provided on the pilot phase linked to the implementation of the
EU CTR. The recent changes in the French legislation impacting clinical trials
will be reviewed and discussed.
Venue: Paris St Ouen (RER C)
Address: QuintilesIMS, 151-161 Boulevard Victor Hugo, 93400 Saint-Ouen, France
Date: 17 March 2017
Time: 10.00am – 3.30pm (CET)
This event is free for TOPRA members, as part of your membership package.
Please find a summary agenda below. Presentations will be in English but there will be a mix of French and English during discussions.
| Time |
Topic |
Speaker |
10 min
|
Introduction |
Gabriel Bohl |
45 min
|
EU CT regulation
|
Gabriel Bohl
|
1 h
|
Phase pilote France
|
Sophie Sénéchal
|
1 h |
Discussion
|
|
Followed by a networking lunch
Langue: Anglais pour les présentations Questions possible en Français
Language: All presentations will be in English, questions may be in French
More details about the speakers:
Sophie Senechal-Cohen
Head of GCP and CT Regulatory/EC/Administrative Unit, AstraZeneca
20 years of experience in clinical research within international pharma companies; started as CRA then moved to training and quality control activities. Now leading the Unit in charge of GCP and regulatory activities in AZ Clinical Trials Unit in France.
Gabriel Bohl
Topra In France Lead, Regulatory Advisor - Quintiles IMS
Gabriel Bohl has expertise in supporting multinational clinical studies from a regulatory perspective. He joined the QuintilesIMS Regulatory Affairs group based in France in 2004 providing support to customers and acting as Regulatory Expert. Previously he spent 2 years at the European Pharmacopeia as pharmaceutical assessor and worked also 7 years in the pharmaceutical industry in project management and international regulatory affairs.
Member = free
Non members = £25 (which gives you 2 months of complimentary TOPRA membership)
CPD
By attending this TOPRA In you have completed 5 CPD hours, to learn about why CPD is important visit the Lifelong Learning page.