Clearing the US and EU Regulatory Path to Product Approval – “What Similarities and Differences Exist and How Can Companies Manage the Hurdles?”

Learn how to navigate through the complexities and policy changes that biotech and nanotech products face today. Expert advice and case studies will provide valuable lessons on how policy and regulation is influencing technology in the US and EU and what companies can do to save time and cost throughout the process. Do regulatory agencies have the legal authority to make judgments on nanomaterials? Are they ready for this responsibility?

Clearing the US and EU Regulatory Path to Product Approval – “What Similarities and Differences Exist and How Can Companies Manage the Hurdles?”

Learn how to navigate through the complexities and policy changes that biotech and nanotech products face today. Expert advice and case studies will provide valuable lessons on how policy and regulation is influencing technology in the US and EU and what companies can do to save time and cost throughout the process. Do regulatory agencies have the legal authority to make judgments on nanomaterials? Are they ready for this responsibility?

Featured Speakers:

Kjell Srandberg, M.D., Ph.D.
Advisory Board Chairman NDA,
Regulatory Consultant Service AB,
Former Director General of the Swedish Medical Products Agency & member of CPMP

Ricardo Carvajal,
Esq. Of Counsel, Hyman, Phelps & McNamara, P.C.,
former – FDA Counsel

Moderator: Michael A. Swit, Esq.
Vice President, The Weinberg Group

Place: Morrison & Foerster, 12531 High Bluff Drive, Suite 100, San Diego, California 92130

Date: Thursday, April 10, 2008

Time: 5:30 pm - 8:30 pm
5:30pm Reception and networking
6:30pm Program begins

Place: Morrison & Foerster, 12531 High Bluff Drive, Suite 100, San Diego, California 92130