Leveraging Global eCTD Efficiencies

Using the eCTD allows for many different advantages over the traditional paper submission but global standards are yet to be developed and therefore eCTD submissions can provide challenges.  With the multiple filing procedures in Europe - which filing procedure is most appropriate? Should a sponsor file individual submissions or combined submissions? What is the timeline for all Reference Member States to accept eCTD submissions? 

Beginning in 2009, the Association of Southeast Asian Nations (ASEAN) is requiring that submissions be formatted to the ASEAN CTD specifications.  What are the formatting requirements for the ASEAN CTD? What is the timing for and countries affected by this new implementation? 

And finally even though eCTD submission is becoming more & more common in the US, what are the industry metrics & benchmarks for best submission timelines and what areas can be made more efficient?

ExL Pharma's 2nd Emerging Global Electronic Submission Standards Conference will once again provide insight into the current global landscape for regulatory submission acceptance while continuing to examine the make-up of companies currently leveraging eCTD standards.

I urge you to join us in Washington this January to gain from this educational atmosphere!


Matthew Millman                      
Conference Director
mmillman@exlpharma.com

Kristen Hunter
Team Leader, Production

Who Should Attend

This Summit is specifically designed for C-Levels, Department Heads, Vice Presidents, Directors and Managers at pharmaceutical, biotechnology and medical device companies from the following departments:

  • Regulatory Affairs
  • Regulatory Operations
  • Regulatory Compliance
  • Data Management
  • Document Management
  • Submissions/Electronic Submissions
  • Database Management
  • Clinical Operations
  • Project Management
  • IT
  • Quality Assurance/Quality Compliance
  • Information Management
  • Medical Writing
  • Data Standards


This conference is also of interest to:

  • eSubmission/Regulatory Consultants
  • eCTD IT/Software Providers