Module 12 2019

Challenges of eCTD within MRP/DCP

HQ ´ s

Local affiliates

Local affiliates

Local affiliates

Common Technical Document

Submission through affiliates, directly from HQ ´ s to agency, use of portal

eCTD ´ s

Challenge to handle national documentation inside eCTD for MRP/DCP

The Organisation for Professionals in Regulatory Affairs