European pharmaceutical and medical devices companies operate in an environment which is heavily regulated at the EU level. The complexity of this EU regulatory environment is ever increasing and the Court of Justice of the European Union (ECJ), Europe’s highest court, plays an important role in the interpretation and application of these rules.
In this webinar, two life sciences regulatory experts will guide you through the ECJ’s latest judgments in the field, which span topics as diverse as, for instance, data exclusivity, liability for defective products and parallel trade, and provide practical tips for your business. The speakers will also update you on the key cases to watch in 2018. This webinar is a must for everyone involved in life sciences regulatory affairs.
Catherine Longeval specialises in litigation before the Belgian and EU courts and advises clients on a wide range of issues, including life sciences law. Her expertise in this area covers laws governing medicines, biotech products, medical devices, cosmetics and food supplements, among other aspects.
Catherine began her professional career in October 1989. Prior to joining Van Bael & Bellis in 1994, she worked as an associate with a leading Brussels law firm.
She regularly lectures and writes on life sciences regulatory matters and procedural law matters. She often speaks at conferences.
Koen specialises in dispute resolution with a focus on the life sciences sector (medicines and medical devices). In addition to his contentious work, Koen advises life sciences clients on Belgian and EU regulatory matters. His expertise covers a wide range of areas, including clinical trials, marketing authorisations, reimbursement matters, advertising and promotion, distribution issues and aspects of competition law.
Notable experience includes: assisting a prominent medical devices company in a dispute with the Federal Agency for Medicines and Health Products in relation to the classification and distribution of certain of its products; representing a major pharmaceutical company in proceedings before the Committee for Deontology and Ethics in the Pharmaceutical Industry of pharma.be; and representing a number of pharmaceutical companies in civil and administrative proceedings initiated by a parallel trader.