Hein van den Bos
Partner Global Regulatory
Languages
English, Dutch, French, German, Spanish
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Overview
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Experience
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Credentials
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Insights and events
LMG Life SciencesLMG Regulatory Life Sciences star
Hein van den Bos helps Life Sciences companies with EU regulatory matters. He assists pharmaceutical, biotech, medical devices and food companies on matters relating to the development, approval and marketing of their products. This includes advice on the regulatory approval pathway through the European Medicines Agency (EMA) as well as assistance on life cycle management issues such as regulatory data exclusivity and orphan exclusivity, pharmacovigilance, clinical trials, distribution and advertising and promotion.
He also assists on a number of compliance matters, such as financial relations with health care professionals, anti-corruption and sunshine rules as well as commercial contracts. Furthermore, Hein helps companies with pricing and reimbursement matters in the Netherlands as well as with EMA and Dutch government investigations and enforcement measures.
LMG Life SciencesLMG Regulatory Life Sciences star
Representative experience
Advising innovator pharmaceutical and biotechnology companies on EU regulatory data protection, EU orphan market exclusivity and the interplay of those regulatory incentives with patents.
Advising innovator pharmaceutical and biotechnology companies on the implications of the EU Pharma Law Package 2023, in particular with respect to regualtory exclusivity rights.
Drafting and negotiating clinical trial agreements.
Assisting pharmaceutical companies with compliance with EU pharmacovigilance ("PV") requirements, including responding to EMA PV inspections and helping companies prepare for EMA PV inspections.
Defending companies in administrative law litigation against enforcement decisions by competent authorities in the Netherlands in various regulated industries.
Assisting pharmaceutical, biotech and medical devices companies with setting up and implementing compliance programs concerning pharmaceutical advertising, anti-corruption and interaction with HCPs.
Advising on advertising materials for food, medicinal products and animal health and litigating advertising disputes before industry code committees and before the courts.
Credentials
- MA, International Relations, University of Groningen, 2004
- Master of Laws, University of Groningen, 2003
- Amsterdam
- Dutch Association for Pharmacy and Law