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Hanneke Later-Nijland

Hanneke is both a lawyer and a pharmacist. She specialises in EU and national legal and regulatory issues relating to medicinal products. Hanneke holds a PhD in clinical pharmacokinetics and she is also a former Inspector for Clinical Trials and Pharmacovigilance at the Netherlands Inspectorate for Healthcare (IGZ). This unique combination of a dual background as well as relevant experience at the competent authority gives her a unique perspective and understanding of the Life Sciences sector.

In her practice, Hanneke advises life sciences and healthcare clients and litigates on a wide range of issues, often with a regulatory focus. Her areas of expertise in the medicinal products field covers marketing authorisations, reimbursement, compliance, pharmacovigilance and advertising issues. In addition, she also assists clients with product liability issues and IP and regulatory issues in transactions in the life sciences sector.  

She is a lecturer at Leiden University and she publishes frequently on regulatory life sciences issues, such as, new European legislation and the impact of recent judgments in the sector. 

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Economic operators under the MDR and IVDR: my presentation at the MedTech Summit 2018 in Brussels concerning the ne… https://t.co/APCFVfezxF

Hanneke's articles

Article

Does EC40, a chlorhexidin lacquer to prevent tooth decay, qualify as a medicinal product or not?

The Dutch Minister of Healthcare decided that EC40, a lacquer containing chlorhexidin used for the purpose of preventing tooth decay, should be regarded as both a medicinal product by presentation as well…

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Article

The Netherlands ∙ Proposed Solutions to Tackle Expensive Medicines in The Netherlands: A Critical Review

If you have an interest in Life Sciences, I am glad to draw your attention to my Report in the latest edition of the European Pharmaceutical Law Review (EPLR). As many of…

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