Construction of the European Drug Master File
Sign up to be notified of new teleseminars daily! |
| Description: | Overview: Drug master files serve as documentation on the quality of an active ingredient or excipient and are submitted by a manufacturer as part of the licensing or amendment procedure. 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 Who will benefit: This webinar will provide valuable assistance and guidance to manufacturers who must prepare and submit the Drug Master File (Active Substance Master File) to European Competent Authorities. Employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the EDMF process and expectations Regulatory Affairs Clinical Affairs Quality and Compliance Marketing & Sales Distributors/Authorized Representatives Engineering/Technical Services/Operations Consultants Speaker Profile David Dills , Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape. |
| URL: | http://www.compliance4all.com/control/w_product/~product_id=500840LIVE |
| Date: | Thursday, December 8, 2016 |
| Time: | 3:00pm-4:00pm UTC |
| Duration: | 1 hour |
| Access: | Public |
| Category: | Webinar*, Technology*, Marketing*, Health*, Industrial*, Finance*, Education*, Environment*, Business* |
| Created by: | compliance4all |
| Updated: | Thursday, November 3, 2016 11:29am UTC |
| : | One Dial-in One Attendee Price: $150.00 |
| : | 18004479407 |
| : | support@compliance4All.com |
| : | Event Manager |
| : | 18004479407 |
| Comments: | None |