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.

Agenda:-

DAY 01(11:30 AM - 7:30 PM)

• 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

DAY 02(11:30 AM - 7:30 PM)

• 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.)

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