With the multiple filing procedures in Europe, the eCTD presents many interesting challenges. Which filing procedure is most appropriate? Should a sponsor file individual submissions or combined submissions for the Reference Member State (RMS) and the Concerned Member States (CMS)? Which countries accept eCTD-only submissions, eCTD with a paper copy of one or more modules, or non-eCTD Submissions (NeeS)? What is the time line for all Reference Member States to accept eCTD submissions? In addition to the challenges of choosing the appropriate filing procedure, Sponsor organizations must also understand the concept of life cycle management for the eCTD and NeeS submissions. Unlike FDA, EU has specific requirements for tracking the submission life cycle management approach in Module 1, and the approach for lifecycle management is dependent upon which filing procedure has been selected.
Understanding what information needs to be provided to the RMS and CMS also represents unique challenges for the eCTD life cycle management. For sponsor organizations considering global submissions, the significance of understanding eCTD life cycle management is critical to ensuring a successful and smooth submission process.
Lifecycle Management of the eCTD and NeeS in Europe is being presented by Gina Ross, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates and airs on Tuesday, April 21, 2009. For more details or to register, please visit our site at www.fxconferences.com
