Status Update on the Implementation of IDMP
- Head of Data Management and Regulatory Information Scientist
- Qdossier, Netherlands
Michiel Stam works as a Regulatory Information Scientist and is heading the Data Management group at Qdossier. He is a specialist in electronic submissions and regulatory information management and worked for various Pharma and Biotech companies in the past 10 years. Michiel has a strong focus on registration tracking, master data management, XEVMPD and IDMP.
- Associate Director
- Iperion, Netherlands
Remco Munnik is Associate Director of Iperion Life Sciences Consultancy, with 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.