Particular areas of expertise: Biopharmaceuticals, Regulatory, CMC, Quality, Pharmaceutical Development
Over 20 years of experience with (bio)pharmaceuticals, both in the industry, and as an assessor for the Dutch authorities.
Strength in providing a strategic, scientific-technical approach to regulatory and quality affairs on the path to – and establishment of appropriate regulatory documentation for submission and replies to the European and US Authorities for clinical trials, marketing authorisations, and post-marketing authorisation obligations. Also regularly asked to provide support in due diligence.
Examples of the classes of products previously worked on are: recombinant proteins/MAbs including complex, controlled-release formulations, biosimilars, recombinant vaccines, plasma-derived medicinal products, and gene-therapy products.
Regularly invited as a speaker or panel member for events of professional associations and as a trainer for courses. Initiator and co-organiser of a series of European conferences for the Parenteral Drug Association on GMPs for IMPs. (co-)Author of bookchapters on "Registration of Biotechnology Products" and on "The Regulatory Environment for Biopharmaceuticals in the EU".
