"This session will describe the dramatic increase over the last few years in the number of GMP inspections by health authorities inspecting pharmaceutical company manufacturing facilities outside of their own borders. Panel members will
explore concerns related to those inspections, including the threat to manufacturers' intellectual property and the heavy financial and resource burdens for both industry and regulators. These burdens and threats are balanced against the value to the GMP state of the facilities and quality of the products, and thus to public health. U.S. and international protections related to intellectual property, as well as the role and concerns of the foreign health authorities, will be presented."

Objective1:Identify reasons for the huge increase in the number of foreign inspections of manufacturing facilities over the last few years.

Objective2:Describe concerns, burdens and potential issues related to the increased inspection activity.

Objective3:Outline alternatives to inspections that ensure drugs and biologics meet high-quality GMP standards and allow best use of resources worldwide distribution.