In February 2020, EMA published Iteration 1 of the EU ISO IDMP Implementation Guide.
The EU IG provides detailed guidance on how ISO IDMP data fields should be interpreted, submitted and maintained within the EU regulatory framework supported by SPOR (Substances, Products, Organisations and Referentials Management Services).
In order to assist with the digestion of the published documentation, we organized a webinar session to address the EU IG. During the webinar we explained the different chapters and we made a comparison between xEVMPD and IDMP requirements.Watch the webinar on demand
Reactions to the webinar:
“The presentation was very nice and useful, not only for the industry, but also for regulators as trying to understand the scope and work load connected to this project.”
“Thank you for your voluntary & excellent support to the industry, the webinar below was very informative.”
Hosted by Remco Munnik
Your host during this webinar is Remco Munnik, who is a member of the EU IG Focus Group chapter 2. 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.