Providing DMFs in eCTD format

Why Should You Attend:

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.

Drug Master Files are required to be submitted in the format of the CTD. The FDA have also begun to accept Drug Master Files (DMFs) in eCTD format and over time will require that they be submitted electronically.

In this webinar, you will gain an understanding of the content and format requirements of the CTD/eCTD. You will also gain the knowledge to prepare for submitting DMFs in eCTD format, including organizing information electronically, tools and software to be implemented for the eCTD preparation and submission, and technical aspects and requirements for an acceptable eCTD.

Areas Covered in the Webinar:

• Review of the CTD format and content requirements for the DMF
• Discussion on successful transition from other formats to the CTD/eCTD
• Technical requirements for an eCTD submission
• Document naming requirements
• Building the folder structure
• Internal document requirements for the eCTD
• Performing “pre-publishing” work for each document
• Tools for tracking and managing eCTD content
• Performing quality checks on the eCTD
• Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)

Who Will Benefit:

• Regulatory Affairs
• Quality Assurance
• Pharmacovigilance
• Project Management
• Regulatory Operations
• Anyone responsible for providing content for the CTD

Instructor Profile:

Peggy J. Berry, MBA, RAC, is the president and CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was vice president of regulatory affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was vice president of regulatory affairs and quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held regulatory affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

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