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
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.
Compliance4All DBA NetZealous,
Email: [email protected]