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. Reformatting for multiple submissions is substantially limited. 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.
This two day workshop will provide you with an in-depth review of the content and format requirements of the CTD/eCTD. Hands-on activities will include organizing specific study reports and other documents into the CTD, using tools for the project management of the CTD preparation, and pre-publishing an eCTD.
Who will Benefit:
- Regulatory Affairs
- Quality Assurance
- Pharmacovigilance
- Project Management
- Regulatory Operations
- Medical and Technical writers
- Professionals preparing IND, DMFs, NDAs and other submissions
- IT Professionals
- Anyone responsible for providing content for the CTD
- Registration Process - (8:30 am till 8:45 am)
- Lecture 1: Overview of the drug development program and source of relevant submission documents
- Lecture 2: Discussion of the roles and responsibilities for CTD preparation
- Lecture 3: Review of the CTD format requirements
- Lecture 4: Discussion on the successful transition from other formats to the CTD
- Lecture 5: Placement of content into the CTD format; including less obvious items
- Lecture 6: Review of different requirements across regions (US, EU, Canada)
- Lecture 7: Implementing tools for the project management of CTD preparation and publishing
- Lecture 8: Technical requirements for an eCTD submission
- Lecture 9: Document naming requirements
- Lecture 10: Building the folder structure
- Lecture 11: Internal document requirements for the eCTD
- Lecture 12: Performing "pre-publishing" work for each document
- Lecture 13: Tools for tracking and managing eCTD content
- Lecture 14: Performing quality checks on the eCTD
- Lecture 15: Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)
Martha French
Consultant, Martha French Consulting
Martha French have over 28 years combined experience in biomedical research and regulatory affairs. As Vice President of Regulatory Affairs at Bellicum Pharmaceuticals she was responsible for the management of all US and European pre-market regulatory activities for novel CAR and TCR T cell therapies that incorporate molecular switches. As Director of Regulatory Affairs at InGeneron Inc., she was responsible for the management of European and US regulatory activities for medical devices that prepare autologous regenerative cell therapies at point of care. At Introgen Therapeutics, Martha led US and European pre-market regulatory activities for three novel biologic products. She was responsible for the filing of the first gene therapy Biologics License Application (BLA) to the FDA and filed two gene therapy Marketing Authorization Applications (MAA) to the EMA. At Valentis, Inc. (formerly Gene Medicine Inc.), Ms. French led the Analytical Sciences core teams in support of the company’s cardiovascular, oncology and PEG protein programs. With long tenure at Lark Technologies, as Vice President of Operations, she managed the DNA sequencing, library screening, restriction enzyme mapping and PCR services. Ms. French graduated from Carroll University with a Bachelor of Science in Biology, taught Regulatory Affairs for the 2008 Human Gene Therapy course at the University of Texas Graduate School of Biomedical Sciences.
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