Common Technical Document (CTD) / Electronic Common Technical Document (eCTD) content and format

Common Technical Document (CTD) / Electronic Common Technical Document (eCTD) content and format is organized by International Pharmaceutical Academy (IPA) and would be held during Nov 7 - 8, 2016 at Holiday Inn Montreal Aeroport- Airport, Montreal, Quebec, Canada. The target audience for this medical event basically for Healthcare Professionals.

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.

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.

Course Content :

• Overview of the drug development program and source of relevant submission documents
• Discussion of the roles and responsibilities for CTD preparation
• Review of the CTD format requirements
• Discussion on the successful transition from other formats to the CTD
• Placement of content into the CTD format; including less obvious items
• Review of different requirements across regions (US, EU, Canada)
• Implementing tools for the project management of CTD preparation and publishing