Providing DMFs in eCTD format
Duration : 90 Minutes
Peggy J Berry,
Peggy J. Berry, MBA, RAC, is the President & 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, Read more
This webinar will review the CTD format and content requirements for the DMF. It will discuss the transition from other formats to the CTD/eCTD and technical requirements for eCTD submission.
Course Objectives:
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.
Course Outline:
• 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.
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Regulatory Affairs
• Quality Assurance
• Pharmacovigilance
• Project Management
• Regulatory Operations
• Anyone responsible for providing content for the CTD
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
