WEBINAR ON DEMAND
Amplexor Life Sciences Suite | IDMP From Two Perspectives: Theory and Practice
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
About the webinar
Watch our webinar for a general status update on IDMP.
In this session, you’ll learn about:
- The data model updates
- The future of data submission
- How the current 3rd acknowledgment process will be addressed
- …and more
About the speakers
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.
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.
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