Type II Drug Master Files for Early-Stage, Small Molecule, Drug Development: Regulatory Management, Quality Considerations, and eCTD Submission

Despite the 2019 publication of the FDA Guidance, Drug Master Files, considerable questions remain regarding the regulatory management, quality considerations, and electronic submission of Drug Master Files (DMF). Dive deep into the world of Type II Drug Master Files (DMFs) with our comprehensive webinar, designed specifically for early-stage sponsors engaged in small molecule drug development.

This session is your roadmap to efficiently navigate important aspects of Type II DMF management, quality components, and submission strategies that are essential for seamless filing and maintenance. Led by industry experts, this webinar will arm you with the knowledge and tools to optimize your master file submissions.

Watch this Webinar, If You:

• Have questions on managing administrative components, regulatory documentation, and holder obligations of Type II DMFs?
• Face challenges determining what CMC information is sufficient for each phase of the investigation?
• Lack clarity on how to navigate the industry requirements for organizing the DMF content to ensure technical compliance with FDA’s Submissions Standards Catalog?

This webinar is a must-attend event for sponsors involved in the early stages of small molecule drug development, and interested in learning how to successfully prepare, submit, and manage Type II DMFs.

What You Will Learn

• Regulatory Management: Administrative process, regulatory documentation, and holder obligations for Type II DMFs
• Quality Considerations: CMC (Module 3) content of Type II DMFs and FDA expectations during small molecule drug development
• eCTD Submission: Submission recommendations for Type II DMFs, including eCTD structure, delivery, and conversion of existing DMFs to eCTD