IDMP from two perspectives: theory and practice

21 October 2020 | Online

Catch the latest updates on the newest release of the EU IDMP Implementation Guide and on the Medicinal Product Information data model the process for data submission to the Target Operating Model (TOM).

In December of this year, the second version of the EU IDMP Implementation Guide is expected to be published and will contain updates on the Medicinal Product Information data model and the process of how product data is to be submitted as part of the TOM. This publication will be the start of a 24 month period before IDMP becomes mandatory for the industry as a whole.

Siniša Belina, Senior Life Sciences Consultant at Amplexor, will address the impact of the EU IDMP Implementation Guide on the Amplexor Life Sciences Suite by demonstrating the implementation of the required IDMP data fields as part of the ProductExpert solution. He will additionally discuss what processes need to be put in place to ensure compliance with the TOM within the RIMExpert solution.

This webinar will also feature Frits Stulp, Managing Director of Iperion Life Sciences Consultancy and IDMP expert, who will give a general status update on IDMP and will also cover data model updates, as well as the future data submission process according to the proposed TOM. This will also include some insights on how the current 3rd acknowledgment process will be addressed.

Meet the Speakers

Siniša Belina

Senior Life Sciences Consultant, Amplexor

Siniša Belina is a Senior Life Sciences Consultant within Product Management team. He applies his detailed knowledge of pharmaceutical processes and documentation to the areas of business process analysis, optimization of software solutions and demonstration of their capabilities. He started his professional career at Pliva (now the TEVA Group), where in addition to his responsibilities in manufacturing, he engaged in a successful EDMS implementation project. He later joined KRKA’s Regulatory Affairs Department, and finally moved to Amplexor in 2008. Siniša received his Bachelor of Science degree in Pharmacy from Zagreb University.

Frits Stulp

 Managing Director of Life Sciences Consultancy, Iperion

Frits Stulp is Managing Director of Iperion Life Sciences Consultancy, with over 20 years of industry and consultancy experience. In this role he leads a team of regulatory / IDMP experts active in various projects to deliver value to both pharmaceutical companies as well as regulators. Frits is the IDMP topic group lead for the IRISS Forum and heavily involved as EU-SRS project manager for Medicines Evaluation Board / European Medicines Agency as part of SPOR landscape. He is also member of the EMA ISO IDMP Task Force Substances & Products. Regarded as an SME on IDMP, he gladly shares his gained knowledge and experience in various occasions around the globe.