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).

Webinar

In order to assist with the digestion of the published documentation, we are planning a webinar session to address the EU IG and answer your questions.

To best prepare for this webinar, we want to give you the opportunity to raise questions in advance.

Iperion consultants have been active on ISO IDMP and EU Implementation Guide preparations and review.  This makes us your ideal partner to raise your questions to.

Currently we are even working with EMA in the development of version 2 (EU IG v2), which will provide the basis for medicinal product data exchange in the EU. This gives you the opportunity to give feedback and suggestions we can bring to the table.

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.

 

 

Please send your questions before 15 March. Your questions will remain anonymously.

When you send in your questions, you will automatically sigh in for the webinar. An e-mail with the details will be send to you a week before.

 

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