This Webinar will focus on the European Community procedure where information can be provided to the authorities and the applicant, where the active substance manufacturer is not the applicant for a product marketing authorization, with a view to protecting valuable manufacturing know-how. This session will use the words “medicinal products” and these cover both products for use in humans and veterinary products. This Webinar will focus on the European, not FDA’s DMF or Master File.
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.
- When to submit an EDMF? Who can submit an EDMF?
- Where and how to submit an EDMF? Are EDMFs to be approved by the authorities, e.g., the Competent Authorities in Europe?
- Recordkeeping requirements and your responsibilities.
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