Kora Doorduyn - van der Stoep

Company: MEB
Kora

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).