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Hotel Holiday Inn

May 23, 2016 9:00 AM - May 23, 2016 5:30 PM

Haagse Schouwweg 10, 2332 KG Leiden, Netherlands

TUTORIAL 2 - REGULATORY INFORMATION MANAGEMENT AND IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP)

Instructors

Frits  Stulp, MSc

Frits Stulp, MSc

Life Sciences & Healthcare Industry Leader for the Netherlands, Deloitte, Netherlands

Frits Stulp is Managing Director of Iperion a Deloitte business, 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 in the EU-SRS project for the Medicines Evaluation Board / European Medicines Agency as part of SPOR landscape. Frits is also Chariman of the Board of CTADHL, involved in Transatlantic adoption of IDMP (www.ctadhl.org). Regarded as an SME on IDMP, he gladly shares his gained knowledge and experience in various occasions around the globe.

Jasper  Riksen

Jasper Riksen

Regulatory Operations Associate, Astellas Pharma Europe BV, Netherlands

Jasper is one of the consultants at the Iperion Consultancy firm specialized in the implementation of IDMP and XEVMPD at pharmaceutical companies. He has worked on these topics since 2012 from start to finish as a business architect, including activities such as data collection and quality control, system requirements specification and implementation, procedure creation and data migration projects. Jasper has a background in chemistry and innovation management, and he enjoys solving the puzzles imposed by these new requirements and regulations.

Michiel  Stam

Michiel Stam

Management Consultant, MAIN5 Gmbh & Co. Kgaa, Germany

Michiel has 15 years of experience in Regulatory Affairs and Information Management. He provides strategic direction and subject matter expertise for implementation of Regulatory Information Management (RIM) solutions. His focus goes beyond compliance, Michiel specializes in unlocking the true value of an organization’s data – whilst taking advantage of initiatives such as XEVMPD, IDMP and SPOR. Through the alignment of people, cross-functional processes, and tools, he has enabled efficient and sustainable data quality for a wide range of customers.

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