Module 12 Presentations

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

Challengeto handle national documentation insideeCTDfor MRP/DCP

The Organisationfor Professionals in Regulatory Affairs