Hanneke is the only pharmacist-lawyer, holding a PhD and ex-inspector in the Netherlands, and possibly the only one in the European Union. She specialises in EU and Dutch regulatory life sciences law (mainly pharma and biotech) and focusses on both contentious and non-contentious work.
Owing to her dual background, Hanneke is eminently qualified to handle the full range of issues relating to marketing authorisations, clinical trials (and agreements), compliance, issues with ATMPs, compounding, demarcation issues, advertising, administrative fines, reimbursement, financial arrangements, preference policy procedures and inspections.
Due to her background as an inspector for healthcare, she often interacts with various national authorities (e.g., the Medicines Evaluation Board, the Health and Youth Care Inspectorate, the Ministry of Health, the Royal Dutch Pharmacists Association), and/or the European Medicines Agency. She also works (with patent attorneys) on issues at the interface between regulatory and IP.
Hanneke and her team regularly assist in due diligence processes in transactions.
Hanneke lectures in pharmaceutical law at Leiden University, speaks regularly at national and international conferences and events and publishes regularly on as new legislation or recent judgments.
She is admitted to the Bar of Amsterdam, and is allowed to practise throughout the Netherlands.