WCS Consulting Inc.3190 Stirling Rd, Unit K4, Hollywood, FL 33021,

Hollywood,

FLORIDA,

United States,

ZIP: 33021

Phone: 347 282-5400

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.
 

Who will Benefit:

• Regulatory Affairs
• Quality Assurance
• Pharmacovigilance
• Project Management
• Regulatory Operations
• Medical and Technical writers
• Professionals preparing IND, DMFs, NDAs and other submissions

Agenda

Day 01(8:30 AM - 4:30 PM)

• 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

Day 02 (8:30 AM - 4:30 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.)

Peggy J. Berry
MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official)

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.