Webinar on Orphan Medicinal Product Designation in the EU

Overview:
The European Medicines Agency plays a central role in the development and authorization of medicines for rare diseases. These medicines are termed ‘orphan medicines’ in the medical world.
It is estimated that today in the EU, 5-8000 distinct rare diseases affect 6-8% of the population - about 30 million people. Rare diseases are defined as life-threatening or chronically debilitating conditions that affect no more than 5 in 10,000 people in EU.

Areas Covered in the Session:

Legal background
The COMP
Criteria for designation
How to describe the medical condition
How to deal with subsets
Significant benefit
Timing of designation

Who Will Benefit:

Regulatory Affairs personnel
Senior management
Project Managers
Medical writers
CRAs and CRCs
QA / Compliance personnel
Investigators
Clinical Research Scientists
QA / QC Auditors and Staff
Consultants

Speaker Profile:

Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands.
He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004 he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003 he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany.

Contact Detail:

NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://bit.ly/Orphan-Medicinal-Product-Designation-in-the-EU