eSubmissions Conference

With the global trend to move towards the electronic environment, regulatory teams are not only presented with the challenge of effectively transitioning to the eCTD, but are now expected to deliver higher quality submissions faster and more efficiently. In addition, new telematics standards and requirements are increasing workloads and demands on those team delivering regulatory submissions. To enable industry to perform, optimising the use of NeeS, eCTD and new standards such as XEVMPD is proving critical.

In 2012, we bring you our 2nd annual e-Submissions conference, providing a comprehensive overview and latest experiences of European electronic telematics and submission initiatives, including: XEVMPD, EU Module 1, CESP, eCTD 4.0...

Additionally, 14 in-depth industry case studies will demonstrate the best practices and common pitfalls when developing high quality multiple requirement submissions, transitioning to eCTD for MRP/DCP, archiving eSubmissions, meeting and maintaining XEVMPD compliance and developing a global submission management team – all to give you the tools to get your product on the market, faster.