With the publication of the ISO IDMP EU Implementation Guide V2.0, the actual implementation clock becomes a reality.
The published guidance should give sufficient instructions to all involved parties: Regulators, Industry and Vendors to prepare. As IDMP has a significant impact on the organization and V2.0 provides more insights in the to-be established processes of submission of structured data with the regulatory activities (the Target Operating Model: TOM)Watch the recording
We are extremely proud with the support that our team provided in the draft and review of the EU IG to bring ISO IDMP closer towards reality. We strongly believe in the value of ISO IDMP and look forward in taking the next steps with regards to implementation in Europe.
Reactions to the webinar:
“Fantastic overview of current state of IDMP and very useful and pragmatic – the best IDMP presentation I have seen.”
“Really good material and presentation, good knowledge for questions, thanks very much for allowing people to attend.”
“Great overview! Also helpful to see the implications being put in context of a pharma company. “
Webinar ISO IDMP EU Implementation Guide V2.0
During this webinar, Remco will lead you through the latest changes, open discussion points and new process as part of the TOM. The webinar should provide you a solid basis and answer any question that you might have with regards to the new process and data requirements. We now offer the opportunity to already raise your questions prior to the webinar.
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.