Bringing a generic drug to market can be fraught with regulatory challenges and compliance issues. PTI’s comprehensive 2-day course will clarify the impact of the latest regulatory changes to affect the generics industry, focusing on the major strategic issues facing your generic drug submissions.

Who Will Attend?
Regulatory Affairs Managers/ Officers/ Assistants; Compliance Managers; Product Registration Personnel; Project Managers in Regulatory Affairs; Documentation Managers; Key contributors to submission procedures

Course Leader
Adriaan Fruijtier, Co-founder and Director of Regulatory Affairs, CATS consulting GmbH. Adriaan has over 15 years’ experience in pharmaceutical Regulatory Affairs. He began his early career at Glaxo B.V, moving to Ciba-Geigy B.V in 1990 where he was Head of Drug Regulatory Affairs for 6 years. In 1997 Adriaan joined the EMEA in London as Project Manager for Oncology and Immunology where he remained for 4 years before holding senior positions in Global Regulatory Affairs at Micromet AG and Bayer. Adriaan co-founded CATS Consultants GmbH in 2004 to provide regulatory advice to the Pharmaceutical and Biotech industry.