The U.S. FDA has mandated the eCTD format for electronic submissions as of January 1, 2008.  Increased interest in the adoption of the eCTD has led the European Union to declare that its 27 Member States develop the capacity to accept electronic-only marketing applications in eCTD format by 2009. For the Centralised procedure, EMEA has stated that "Any electronic submission received after 1 July 2009 that is not in eCTD format may require different handling, and will not be subject to the same technical validation and comparative checks as eCTD submissions, which may in turn affect the quality and speed of the procedure and the feedback received."  Also, Health Canada has implemented an electronic review environment for eCTD submissions.    All of the regulators are on record as regarding eCTD as a format that will receive faster, higher quality review and generate fewer questions.

This workshop provides in-depth review and practical advice related to the people, processes, and technology essential for the successful adoption and development of quality eCTD submissions.   The practical advice that you gain will help you not only plan for future applications but understand how to move your existing applications from paper or eNDA to eCTD format.

TOPICS COVERED INCLUDE THE FOLLOWING:

1. From Paper To Electronic - Kathleen Clark
2. Perspectives & Best Practices for Global Electronic Submissions - Cato Research
3. ASK THE EXPERTS - Industry Panel

WHO SHOULD ATTEND

This session should be attended by:

• Regulatory Affairs - Managers/Supervisors/Directors/VPs
• Regulatory Operations - Managers/Supervisors/Directors/VPs
• Quality Assurance - Managers/Supervisors/Directors/VPs
• IT Professionals responsible for the delivery of regulated systems

GlobalSubmit is a long time thought leader in the eCTD arena and intimately involved in the next generation Regulated Product Submission (RPS).   Our partner Cato brings years of hands-on practical experience in helping sponsor organizations move to the eCTD and in producing high quality electronic submissions.