Quality Agreements with Pharmaceutical/ Biologic Manufacturers and the Use of Drug Master Files (Pharmaceuticals Trai)
Venue: Online Event
|Event Date/Time: Mar 30, 2012||End Date/Time: Mar 30, 2012|
This course provides attendees with an understanding of the role that Quality Agreements and DMFs play in the FDA's regulatory approval process for drugs and biologics. The course will take participants through a step-by-step process of when Quality Agreements are appropriate, how they should be prepared, formatting, content and negotiations around the agreement. The DMF section will explain preparation and explain the types of information essential for any Drug Master File. Additionally, this course explains why "one size does not fit all" and emphasizes the importance of customizing DMFs in both preparation and maintenance for particular products and businesses.