EU Clinical Trial regulation - 2017

PUBLISHED 6 months ago BY Compliance4all ON Health and Medicine 94 Views

Overview:
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 Profile:
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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]