We are proud to again sponsor the U.S.-Japan Health Sciences Dialogue, which aims to enhance awareness of healthcare and life sciences issues and opportunities in Japan and the United States by facilitating communication among industry, government, and academic groups from both countries.
FDA partner Kathleen M. Sanzo will moderate and provide an introduction for the following panel:
Beware of GAPs in Your Supply Chain
September 10 | 10:15-11:10 am
High-profile issues related to the quality of food and drugs sourced in global markets have caused the U.S. Congress to include new provisions in the Food and Drug Administration Safety and Innovation Act concerning supplier controls for drugs and the pharmaceutical industry. The FDA is also considering additional mechanisms to ensure the quality of the global sources of drugs. This panel will discuss these new supplier control requirements, approaches to managing supplier quality, and how the new requirements will impact the timing and costs of alliance agreements.
Life Sciences and Healthcare partner Stephen Paul Mahinka will moderate and provide an introduction for the following panel:
Comparative Regulatory Machinery: Making It Work on Both Sides of the Pacific
September 11 | 10:15–11:10 am
Operating across borders in the pharmaceutical business requires operating in differing regulatory regimes. This panel will explore these differences and discuss what companies need to know to build a regulatory organization that can succeed on both sides of the Pacific.
September 10-11, 2013
The Union League of Philadelphia
140 South Broad Street
Philadelphia, PA 19102
Please see event details for pricing.