Confidential information from the manufacturer must be protected. However, at the same time the license-holder must receive all the information it needs in order to takeresponsibility for the quality of a medicinal product. A drug master file comprises two parts: the Applicant's Part (Open Part), which contains all the information that the license-holder needs to assess the quality and submit a license or amendment application; and the Restricted Part (Closed Part), which contains confidential information about the manufacturing procedure that only needs to be disclosed to the authorities. It should be noted that DMF's may only be submitted in connection with a licensing or amendment application or as part of a periodical review procedure. The DMF should be submitted in the format described in the Common Technical Document (CTD) Part 3.2.S. 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 session:
- 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
- Combination medical device and drug manufacturers will also benefit if you incorporate a medicinal product and how the Competent Authority will assess your Master File
David R. Dills,
Regulatory Affairs & Compliance Consultant ,
David R. Dills
David R. Dills, is currently the Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 32 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations. He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific. He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and com
- Regulatory Affairs
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- Quality and Compliance
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- Distributors/Authorized Representatives
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