Construction of the European Drug Master File (EDMF) for Regulatory Agencies - Webinar by GlobalCompliancepanel 2016

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

Who should Attend

• 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