Event Date/Time: Nov 15, 2007
End Date/Time: Nov 16, 2007
With CDER’s historic announcement, “As of January 1, 2008, eCTD will be the single electronic submission format”, the future is truly now for eCTD. This conference provides a very timely forum for industry to get clarification and guidance on what this means to the Life Science industry as a whole, and for companies submitting electronically. This conference will focus on how to optimize the electronic submission process and benefits. Topics will be presented that facilitate a better understanding of electronic submissions whether you are contemplating your first eCTD, wishing to gain insights into streamlining your current electronic submission process through lessons learned, or are seeking direct interaction with regulators. As in past years, this conference seeks to maintain open communication between the stakeholders (agency, industry and service providers) regarding regulation, guidance and the lessons learned in implementing electronic submissions.