- Worked for more that 25 years in a Global R&D environment (EU, USA, Japan, Norway and Singapore) as member of multi-disciplinary project teams aiming at developing innovative vaccines for all important animal diseases. - Manager of a group of (senior) Scientific Editors Biologicals (PhD and MSc level). - For Merck Animal Health (2nd largest Animal Health Company in the world) kept a strict overview of the whole internal and external R&D Project Portfolio (Biologicals) for all species with focus on the Business Case, Governance and agreed project timelines. - Owner of ReStraCon, a Consultancy enterprise providing full support on all aspects of product registration world-wide. Special expertise in obtaining Marketing Authorizations for Biologicals (vaccines).
Since June 2013
ReStraCon is a Consultancy enterprise providing full support on all aspects of product registration world-wide. Special expertise in obtaining Marketing Authorizations for Biologicals (vaccines). The support deals will all aspects of the product i.e. Manufacturing and Quality (CMC part); the Safety file and the Efficacy file and deals both with new products and support for existing products (variations and/or line extensions). Apart from Regulatory and Scientific support, full knowledge available on Regulatory processes i.e. Central, Decentral, Mutual Recogntion and National procedures. If preferred, the whole regulatory procedure can be taken care of (Dossier compilation, Q&A, and the coordination of the whole regulatory process).
Director Global R&D Portfoliomanagement
June 2008 --- May 2013
Kept a strict overview of the whole internal and external R&D Project Portfolio (Biologicals) for all species with focus on the Business Case, Governance and agreed project timelines.
Senior Scientific Editor
January 1990 --- January 2008
In this role: - Prepared over 20 European regulatory dossiers for vaccines intended for major animal diseases in all important species (Swine, Ruminants, Poultry, Companion Animals [dogs, cats and horses] and Fish). These dossiers covered all parts of product development (production, quality, safety and efficacy) and involved novel antigens, recombinant technology products and multi-component vaccines (biologicals). - Acted as Representative of Intervet towards heads of Regulatory Agencies, especially in Europe (specific: visited on a frequent base the French Regulatory authorities to discuss long standing unsolved issues. Eventually brought the whole Intervet Vaccine portfolio to France) - Represented Intervet as Scientific Expert at Oral Hearings for the highest European Scientific body (CVMP) of the EMEA, defending successfully the applications made by the company. - Managed of group of 8 (senior) Scientific Editors Biologicals (PhD and MSc level)
in from Polytechnics Clinical-Chemistry, Etten Leur, The Netherlands in 1985
in from Courses on Financial Management, Business Administration and Leadership in 0
in from Post academic courses in Molecular Biology, Virology, Immunology and Statistics in 0