Regulatory affairs in the Middle East

3^rd International Conference on Pharmaceutical Regulatory Affairs

October 21-23, 2013 DoubleTree by Hilton Hotel San Francisco Airport, CA, USA

Faycal Aberkane

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

This presentation is more a training course intended to RA professionals than a presentation. The aim is to provide the attendees with: ? An understanding of the key areas of regulatory affairs in the Middle East ? A focus on the practical aspects to assist with regulatory activities ? The opportunity of interactive discussion and exchange of experience with the speaker. Selected country regulation will be covered in depth from a strategy and practical approach.

Biography :

Faycal Aberkane is currently acting as Regulatory Area Leader within the Sanofi Pasteur group, world leader in vaccines, International Regulatory Affairs team, based in Lyon, France. He has a strong regulatory expertise in the Middle East & Africa region for quality and regulatory affairs. He received his Doctorate of Pharmacy (with distinctions) and a Master of Science from Lyon University Claude Bernard, France and has now over 14 years experience in the pharmaceutical industry. He began his career as Deputy Head Pharmacist at Aventis Pasteur. He has been involved in many quality assurance fields in the frame of this position including international QA audit and vaccines batch release. In his current regulatory role, he works closely with international health authorities for regulatory affairs and quality subjects related to vaccines. His responsibilities include international license maintenance, industrial project such as new facilities implementation, international regulatory site inspections, organization of lobbying seminars, launches of new vaccines and organization of technical regulatory training intended to health authorities. He has spoken several times on the topic of professional training in regulatory affairs for the management forum group in London and is a regular speaker on regulatory topics at the University of Pharmacy.