Dr. Stephane Andre is Head of EU/International Regulatory Affairs of the Hoffmann - La Roche and Genentech integrated company in Basel as well as core member of the Drug Safety Committee. He has been working in the field of regulatory affairs since 17 years up to now. From 1995 to 1999 he was Associate Director in International Regulatory Affairs Liaison, Oncology, Anti-infectives, anti HIV drugs and Director and Head of the Corporate Regulatory Affairs Oncology Liaison Europe at Rhone-Poulenc Rorer. He was Vice President of WYETH Pharmaceuticals in USA from 2000 to 2007 and responsible for different fields, including Womens` Health and Clinical Trial Application. Since 2007 he worked as Site Head of Pharma Drug Regulatory at Hoffmann - La Roche and since 2009 he has been working as Head of the EU/ROW Regulatory Affairs for that company. He is responsible for the Basel regulatory teams, the collaboration with Chugai as well as the Welwyn site Regulatory teams to the EU team of Regularity professionals reporting to Basel team.