IDMP from two perspectives: theory and practice Registration

Date:10/21/2020

Time:1:00 PM EDT

Duration:60 minutes

The second version of the EU IDMP Implementation Guide is expected to be published in December this year. This new release contains updates on the Medicinal Product Information data model and the process of how the product data should be submitted as part of the Target Operating Model (TOM). This publication will be the start of the 24-month period before IDMP becomes mandatory for the industry.

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

Siniša Belina, AMPLEXOR's Senior Life Sciences Consultant, will present the impact of the EU IDMP Implementation Guide on the AMPLEXOR Life Sciences Suite. He will demonstrate the implementation of the required IDMP data fields as part of the ProductExpert solution as well as discuss what processes need to be in place to comply with the TOM within the RIMExpert solution.

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Speakers

Frits Stulp

Managing Director

Iperion Life Sciences Consultancy and IDMP expert

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.

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.