Conference Manager
November 2 - 3, 2017 - Hollywood FL USwcsseminars
support@worldcomplianceseminars.in
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. Why You should Attend The Session 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 Areas Covered • 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 • Technical requirements for an eCTD submission Who will Benefit • Regulatory Affairs • Quality Assurance • Pharmacovigilance • Project Management • Regulatory Operations • Medical and Technical writers Peggy J. Berry. MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official) 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. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Venue DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153 Seminar One Registration- $ 1295 Special Group Discount Register for Four attendees- $ 3885