CMC Regulatory and Technical Strategies: Global CMC Dossier Life Cycle Management
Venue: Doubletree Hotel & Executive Meeting Center
Location: Bethesda, Maryland, United States
Event Date/Time: Feb 16, 2009 | End Date/Time: Feb 18, 2009 |
Description
Regulatory affairs personnel, working together with the development scientists, must see the “big picture†when it relates to the many individual development studies conducted. Thus, the Regulatory Affairs CMC professional must understand the issues faced in each scientific discipline and be able to evaluate the data generated with regard to its suitability for use in a regulatory submission.