The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

Date : 5th November 2021 to 5th November 2021

Place : United States, San Jose

Website :https://www.complianceonline.com/drug-master-files-dmf-translating-fda-guidances-into-usable-documentation-seminar-training-80069SEM-prdsm?channel=allconferencealerts

Contact Person:Ashutos Swain

Description:

This course provides attendees with an understanding of the role that Quality Agreements and DMFs play in the FDA's regulatory approval process for drugs and biologics. The course will take participants through a step-by-step process of when Quality Agreements are appropriate, how they should be prepared, formatting, content and negotiations around the agreement. The DMF section will explain content, format, preparation and the types of Drug Master Files which can filed in the U.S., as well as the EU, Japan and Canada. Additionally, this course explains why "one size does not fit all" and emphasizes the importance of customizing DMFs in both preparation and maintenance for particular products and businesses.

The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities will be held in San Jose,United States on date 2021-11-05

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Deadline for abstracts/proposals : 26th October 2021

Keynote Speakers :

Check the event website for more details.