Construction of the European Drug Master File (EDMF) for Regulatory Agencies (Pharmaceuticals Trai)
Venue: Online Event
|Event Date/Time: Nov 18, 2011||End Date/Time: Nov 18, 2011|
Areas Covered in the Seminar:
- Examine the background and history with the EDMF.
- Learn step-by-step how to construct and submit the EDMF (and this is not FDA's DMF).
- DMF's today are mostly prepared following the rules of Common Technical Documentation (CTD).
- Understand that this is a document containing the information required to demonstrate that the quality of the active substance is adequately controlled by the specification proposed by the applicant.
- Expectations for Applicant's part and ASM Restricted Part of the EDMF.