Variations in Europe

Chairperson CMDh EU representative at the MEB; Kora Doorduyn works at the Medicines Evaluation Board (MEB) in The Netherlands. She held several positions within the MEB, both regulatory and management. Her current position (since 2009) is CMDh member (EU-representative)/Senior Policy adviser. 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. In December 2018 she was elected as Vice-Chairperson of CMDh. She is member of several working parties of CMDh with issues related to Pharmacovigilance legislation (like RMPs/PSUSA's) and variations as an area for special attention. She is acting as CMDh rapporteur for a (HaRP) project to harmonise RMPs for the same active substance in the EU. She is coordinator/Rapporteur EU Training Curriculum for Regulatory experts (for CMDh). She is the NL member of the Notice to Applicants Working Group in Brussels. She graduated MSc Pharmacy (in 1983) and as a pharmacist (in 1985).

General Manager, Regulatory Affairs Director; Lidia Cánovas has over 25 years of global drug development and regulatory affairs experience in the biopharmaceutical industry. She received her degree in Pharmacy from the University of Barcelona, and has a Master in Business Administration in the Pharmaceutical Industry. She is currently the General Manager - Regulatory Affairs of Asphalion, S.L., a consulting company specialized in drug development and regulatory affairs; which she joined in 2003. With over 80 employees with backgrounds in all areas of life science, Asphalion's consultants are experts in their fields and are in direct contact with European agencies for the implementation of new regulatory standards.Her main activities focuses on consulting and strategic management of projects in the area of Regulatory Affairs and Development for Europe and USA, actively participating in Scientific Advice, Pediatric Plans, Orphan Drug Designations, Development Plans, Centralized Procedures, Decentralized and Mutual Recognition in permanent contact with the regulatory authorities. She has extensive regulatory and development experience in innovative, biological, biotech, biosimilars and advanced therapy products.

Director Regulatory Affairs Veronika has over 17 years' experience in regulatory affairs. She works on the life-cycle management of several MAAs and successfully completed many post-marketing CMC variations for biological medicinal products. Veronika is also involved in other relevant areas such as management of post-approval PIP management, CMC change control review, MA renewals, MA transfers etc. She has a scientific background with a doctoral degree in technical chemistry (biotechnology).

Head of Regulatory CMC Wuppertal; Regina is a biologist by training holding a PhD in Natural Sciences and has over 20 years' experience in regulatory affairs. She and her team is specialized on regulatory CMC topics and works on life-cycle management for small and large molecules, on NDAs/MAAs as well as on development projects and respective quality support for CTA/INDs.

Regulatory Affairs Director, Madrid Office André has more than 14 years' experience in CMC Regulatory Affairs and Product Lifecycle Management of Human Medicinal Products in different countries, with several types of products, and for different types of companies. Besides his core CMC expertise, he is mainly focused on CMC writing and strategic guidance, he has also been deeply involved in other relevant areas, such as: - Project lead/management of global projects, - Implementation of EMA Policy 0070 (clinical data transparency), and - eCTD publishing.
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