Speaking on the above topic is Dr Joseph Scheeren, SVP & Head, Global Regulatory Affairs, Bayer Healthcare, United States. He will be making a presentation at Pre-clinical World Asia 2012, part of a series of conferences at the 5th Annual BioPharma Asia Convention 2012.
Dr Scheeren was born and raised in the Netherlands and studied pharmacy at the University of Leiden from 1974-1982. He started in the pharmaceutical industry with Servier in Paris (France) in 1982 and was responsible for regulatory affairs Northern and Eastern Europe. Dr Scheeren also directed Servier's clinical development antenna in Munich (Germany) in 1986 and 1987. In 1991, he was appointed Head of World-Wide Regulatory Affairs of Serono in Geneva (Switzerland) and moved back to Paris at the end of 1992 to take responsibility of the global regulatory affairs department of Roussel UCLAF. After the merger with Hoechst and Marion Merrel Dow, he moved to New Jersey (USA) in 1996 to head up the Global Marketed Product Regulatory Affairs Department of HMR and continued with similar responsibilities for Aventis after the merger of HMR with RPR in 2000. In 2002, Dr Scheeren was nominated to Head of Global Regulatory Coordination and since 2004 has joined Bayer pharmaceuticals as Senior Vice President, Head of Global Regulatory Affairs and is currently also the Montville site Head. Joseph is also a member of the CIRS Regulatory Advisory Board.
Dr Scheeren will be presenting on the following topic:
Customizing your global regulatory strategy for efficient drug development
1. Leveraging on successful regulatory compliance models to conduct clinical trials effectively in Asia
2. Formulating your regulatory strategy to enhance overall drug development lead-time
3. Best practices: Adopting different approaches to fulfill regulatory requirements for local and global trials in Asia
He will aso be participating in the below panel discussion:
Regulatory panel: Overcoming regulatory barriers in Asia to fast-track clinical trials
1. Identifying crucial compliance areas in Asian regulations for accelerated drug approval
2. Mapping the direction of regulatory affairs for Asia in the next five years and identifying areas of improvements
3. Developing a platform to enhance two-way communications between regulators and industry for improved regulatory compliance