On Wednesday, 30 June 2021 EMA has released version 2.1 of the ISO IDMP EU Implementation Guide. This release of this version is a steppingstone towards the implementation of ISO IDMP in Europe and initially for the Centralised Procedure.
Learn all about the recent changes in chapters 2, 3 and 8 and how they impact which additional data elements you need to collect and processes you need to review to achieve IDMP compliance with some concrete next steps.
Time: 3 PM CEST
Presenter(s): Remco Munnik
Hosted by Remco Munnik
Your host during this webinar is Remco Munnik, who is a member of the EU IG Focus Group chapter 2 and 3 and has been supporting EMA during the review and drafting of the EU Implementation Guide. Remco has over 20 years of experience in Regulatory Affairs, with a special focus on Global submission procedures, electronic submission (eCTD) and regulatory data management (xEVMPD, ISO IDMP and RIMS). He has worked at both pharmaceutical industry and consultancy. In addition, Remco has been directly involved in the development and roll-out of the EU Telematics environment and has in-depth knowledge of the systems. Remco is member of the EMA ISO IDMP Taskforce Product & Organisation group.