EU Clinical Trial regulation - 2017
Transition between Directive 2001/20/EC and Regulation EU No 536/2014
Until the Clinical Trials Regulation EU No will become applicable, all clinical trials performed in the European Union are required to be conducted in accordance with the Clinical Trials Directive 2001/20/EC.
Why should you Attend:
Because the current Directive will be significantly altered and replaced by a Regulation which is legally binding on all Member States
Areas Covered in the Session:
- The clinical trial database
- The new evaluation procedure
- Low intervention trials
- Clinical trial assessment and results
Who Will Benefit:
- Clinical Trial Managers
- Regulatory Affairs
- Medical Officers
Speaker and Presenter Information
Salma Michor , PhD, MSc, MBA, CMgr, RAC is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH.
Expected Number of Attendees
100Relevant Government Agencies
Dept of Health & Human Services, FDA, Clinical Trial
Event Type
Webcast
This event has no exhibitor/sponsor opportunities
When
Mon, Jun 12, 2017, 10:00am - 11:00am
Cost
| General Admission: | $150.00 |
Website
Click here to visit event website
Organizer
NetZealous - Compliance4All
