Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities
Thu, 06 Nov
|Virtual Event
Drug Master Files (DMFs) play a pivotal role in the pharmaceutical industry as confidential documents containing detailed information about the manufacturing, processing, packaging, and storage of active pharmaceutical ingredients (APIs), excipients, and other essential components of drug products.
Time & Location
06 Nov 2025, 11:00 am – 12:30 pm GMT-5
Virtual Event
About the event
LEARNING OBJECTIVES:
By the end of the webinar, participants will be able to define what Drug Master Files are, distinguish between different types of DMFs, and articulate their fundamental role in the pharmaceutical industry, particularly in the context of regulatory submissions and approvals.
Participants will acquire the skills necessary to navigate the process of creating a comprehensive DMF, including the essential documentation required for submission. They will also gain insights into common pitfalls to avoid during the submission process.
Attendees will develop a nuanced understanding of the regulatory landscape related to DMFs, including the requirements of major global regulatory bodies such as the FDA and EMA. They will learn how to maintain effective communication with regulatory authorities and address queries to ensure compliance.
Participants will learn the intricacies of managing DMFs throughout their lifecycle, from initial submission to updates and amendments. This includes understanding data integrity, security considerations, and maintaining…