Roll up your sleeves for a two-day unbiased introductory workshop comprised of skill building, interactive exercises, case studies and small group discussions to learn how to prepare an effective electronic Common Technical Document (eCTD) submission on any platform. Every regulatory professional should know the standards, groundwork, expertise and technology required to submit an electronic submission within the US and globally. Due to its cost effectiveness, and because it guarantees a faster response from the recipient regulatory agency, reducing time-to-market, the eCTD has become the standard for numerous regulatory agencies around the world.
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research has required electronic submissions in eCTD format since 1 January 2008 and, as part of the most recent version of the Prescription Drug User Fee Act (PDUFA IV), is implementing a single electronic review environment for all FDA Centers by 2013. In addition, Health Canada has implemented an electronic review environment for eCTD submissions and the European Medicines Agency (EMA) has required eCTD format for Centralised Procedure applications since 1 January 2010. Some regulatory authorities in Europe have implemented only electronic review environments and are now refusing to accept paper submissions. All regulatory authorities who receive eCTD submissions are reporting serious problems with lack of compliance with the electronic format and difficulty navigating the electronic files that comprise an eCTD, which prevent the authorities from conducting their review.