On-Demand Webinar
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
Register Now For On-Demand Access
Don’t miss this opportunity to enhance your DMF regulatory strategy and ensure your submissions meet the highest standards. Register now for on-demand access and take a significant step toward mastering these submissions.
Meet Our Expert Presenters
Margaret Studzinska
Director, CMC and Nonclinical Writing
With more than two decades in the pharmaceutical sector, Margaret is an expert in Chemistry, Manufacturing, and Controls (CMC) including writing, strategy, and operations. She excels in converting complex scientific concepts into compliant regulatory documents effectively. Her session will be indispensable for anyone seeking to understand CMC’s role in early-stage drug development and Type II DMF regulatory submissions.
Christine Clarke
Principal Regulatory Scientist
Christine brings 8 years of combined regulatory affairs, consulting, medical writing, and research experience in the biotech and pharmaceutical industry. She provides regulatory consulting and advisory services for Type II DMFs, and plans and manages other regulatory submissions, including marketing applications and supplements (NDAs and sNDAs) in compliance with Agency requirements. Attendees will benefit from her insights into successfully preparing and managing Type II DMF submissions.
Sandra Atkins
Senior Regulatory Operations Specialist
Sandra’s expertise encompasses over a decade of managing and optimizing eCTD submissions. Her focus on technical compliance, process efficiency, and eCTD conversion makes her advice crucial for streamlining submission procedures. Participants will gain practical strategies from her experiences in regulatory operations.
FAQs
Who is this webinar for?
Early-stage drug developers, regulatory affairs, regulatory operations, and medical writing professionals.
Will there be a recording available?
Yes, a recording will be provided to all registered attendees after the event.