Our webinar on EU Implementation Guide on 30 March 2020 was a success. We have noticed there is a clear need for practical information on the Implementation Guide and the necessary next steps. Due to this success we are planning new webinars on the Implementation Guide, together with MAIN5, especially for the DACH-region.
EU ISO IDMP Implementation Guide
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 are having two webinar sessions to address the EU IG and answer your questions. These webinars, one in English and one in German, are exclusively for the DACH-region. To best prepare for this webinar, we want to give you the opportunity to raise questions in advance.
Collaboration between MAIN5 and Iperion Life Sciences Consultancy
MAIN5 and Iperion have been working on several projects in the past and both have the same drive to help change towards a data driven industry and to support pharmaceutical companies in their digital transformation.
MAIN5 has been actively participating in the adoption of the ISO IDMP standards and their revision as well as in the review of the EU Implementation Guide. Besides progressing a variety of IDMP projects in industry, MAIN5 consultants currently contribute to the initiation of an IDMP handbook at the ISO TC215 working group 6 as well as in their expert group at the elaboration of the logical model of IDMP, both in order to increase the overall IDMP user friendliness.
Iperion consultants have been active on ISO IDMP and EU Implementation Guide preparations and review. Currently they 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.
Remco Munnik 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.
Christine Hirt is Management Consultant and responsible for regulatory business consulting at MAIN5. She has more than 20 years of experience in the field of Regulatory Affairs working for industry and authority representatives. Christine is internationally recognized on expert level for regulatory business processes, guidelines and regulations. She is an active member in several associations, such as DIN/ISO TC/WG6, IRISS, BPI and MEGRA. Participating actively in the IDMP adoption expert group of WG6/TC215/ISO and other expert groups associated with implementing RIMS and IDMP.