br br br eCTD Submissions of IND and NDABLA to the US FDA, EU and Canada (com) Abr Atbr San Franciscobr For more information: br br DESCRIPTIONbr ============br eCTD Submissions of IND and NDABLA to the US FDA, EU and Canadabr br 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. br 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.br br This two day workshop will provide you with an in-depth review of the content and format requirements of the CTDeCTD. 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.br br br Who will Benefit:br ==================br Regulatory Affairsbr Quality Assurancebr Pharmacovigilancebr Project Managementbr Regulatory Operationsbr Medical and Technical writersbr Professionals preparing IND, DMFs, NDAs and other submissionsbr IT Professionalsbr Anyone responsible for providing content for the CTDbr br br br Please contact the event manager Marilyn below for the following:br - Discounts for registering 5 or more participants.br - If your company requires a price quotation.br Event Manager Contact: marilyn.b.turner(at)nyeventslist.combr You can also contact us if you require a visa invitation letter, after ticket purchase.br We can also provide a certificate of completion for this event if required.