Wim is an EU regulatory partner in the firm’s Brussels office, focusing on the life sciences sector.
Wim helps pharmaceuticals, medical devices, cosmetics, and food companies navigate the regulatory process in Europe throughout the life cycle of their products — from planning and development, to approval and marketing, to enforcement and ongoing compliance.
This includes advising clients on a broad range of regulatory issues such as clinical trials, product classification, marketing approvals, Good Manufacturing and Distribution Practices (GMP/GDP), Quality Management System (QMS) requirements, Standard Operating Procedures (SOP), advertising and promotion, HCP/HCO interactions (including false claims and anti-kickback statutes), pricing and reimbursement, pharmacovigilance (drug safety), adverse events reporting, recalls, and import and export restrictions. Wim also counsels start-up biotech or medical device firms on EU market entry strategies and the appropriate regulatory pathway.
He frequently works with Reed Smith’s U.S. FDA team to provide equivalent advice with respect to EU regulations to firm clients on international matters.
In addition, Wim has substantial experience with industry contracts (manufacturing, quality, commercialisation, license, distribution, and supply). He also assists clients with regulatory due diligence evaluations regarding the compliance status of acquisition targets in the life science sector.
Wim has represented clients before EU and national regulatory agencies in investigations and enforcement matters. This work also includes carrying out internal audits, developing corporate compliance programs and assisting with supply chain and product liability claims.
His current caseload includes MDR/IVDR compliance counseling, digital health collaborations, value-based health care challenges, regulatory due diligence, and enforcement matters.
In addition to his life sciences practice, Wim also advises more generally on EU market access matters in multiple industries such as consumer products, industrial equipment, media, technology, and manufacturing. This work includes counseling on product standards (safety, health, environment), regulatory compliance approvals (including CE marking, packaging, and labelling), cross-sectoral requirements (e.g. materials and waste management, sustainability, carbon neutrality) and internal market issues. He advises on both the legal and the practical/procedural aspects of EU law-making, engaging with EU institutions to anticipate, understand, and influence policy and the legislative and regulatory developments which impact clients’ businesses.