Rijk Riksen (MSc, pharmacist) has been active in the field of Regulatory Affairs since 1985 and has gained extensive experience working in the industry and for the Dutch Medicines Evaluation Board (CBG/MEB).
Working experience before establishing Rxn Regulatory Affairs included the preparation and submission of dossiers for marketing authorisation applications and variations as a Senior Regulatory Affairs Manager in various positions, including at the international headquarters of an innovative pharmaceutical company. While working for CBG/MEB he was a reviewer of chemical-pharmaceutical and rDNA biotech dossiers for 6 years. During this period he was one of the Dutch members of the CHMP (then CPMP) Biotechnology Working Party. Later he worked for 5 years in a managerial and front desk advisory role.
Rijk Riksen has thus gained a unique combination of knowledge and experience in the field of regulatory affairs. He maintains a wide network of excellent contacts with officials at all levels at the Dutch Medicines Evaluation Board, the Ministry of Health agency (Farmatec-BMC) and the Health Care Inspectorate (IGZ).
He is co-author of a handbook covering practical and legal aspects of pharmaceutical licences under the 2007 Dutch Medicines Act (publication in Dutch).