Kora Doorduyn - van der Stoep

Company: MEB

She works at the Medicines Evaluation Board (MEB) in The Netherlands. She held several positions within the MEB, regulatory, management. Her current position (since 2009) is CMDh member (EU-representative)/Policy adviser of the department Policy, Governance and Regulatory Affairs. Since May 2009 she is acting as Member and official representative in the CMDh (Co-ordination Group Mutual Recognition and Decentralised Procedures – Human) on behalf of the MEB. She is member of several working parties of CMDh with issues related to (the new) Pharmacovigilance legislation (like RMPs/PSURs) as an area for special attention. She has a very broad experience in coordinating/assessing national and European (MRP/DCP/Centralised procedures) application procedures related to marketing authorisations, variations, renewals, worksharing procedures, CHMP and CMD referrals. She has coordinated/assessed a large number of procedures in the role as CMS/RMS and/or rapporteur. From 2002 -2007 she has been managing both regulatory project leaders and clinical assessors in a Pharmacotherapeutic group. In this position she was also responsible for processing/scheduling all registration procedures within this Pharmaco-therapeutic group. She was also a regular visitor of the MRFG (since the establishment of this group) and she represented The Netherlands in the MRFG from 1 January 1997 until 1 October 1997 during the first Dutch presidency of this group. She graduated MSc Pharmacy (in 1983) and as a pharmacist (in 1985).