Construction of the European Drug Master File (EDMF) for Regulatory Agencies - Webinar by GlobalCompliancepanel 2016 is dedicated to
- How to construct and submit the EDMF (and this is not FDA`s DMF)
- The background and history with the EDMF
- 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
- DMF today are mostly prepared following the rules of Common Technical Documentation (CTD)
- When to submit an EDMF? Who can submit an EDMF?
- Expectations for Applicant`s part and ASM Restricted Part of the EDMF
- Recordkeeping requirements and your responsibilities
- Where and how to submit an EDMF? Are EDMFs to be approved by the authorities, e.g., the Competent Authorities in Europe?
- 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
Construction of the European Drug Master File (EDMF) for Regulatory Agencies - Webinar by GlobalCompliancepanel 2016 brings together:
- Regulatory Affairs
- All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the EDMF process and expectations
- Quality and Compliance
- Clinical Affairs
- Distributors/Authorized Representatives
- Marketing & Sales
- Consultants
- Engineering/Technical Services/Operations
