Hein van den Bos

Partner at Hogan Lovells International LLP

Speaker

Hein van den Bos helps Life Sciences companies with EU regulatory matters. He assists pharmaceutical, biotech and medical devices companies on matters relating to the development, approval and marketing of their products. This includes assistance on life cycle management issues such as regulatory data exclusivity and orphan exclusivity, pharmacovigilance, clinical trials, distribution and advertising and promotion. Hein relishes handling cross-border EU and global regulatory projects, working with colleagues across our global Life Sciences practice.

He also assists on a number of compliance matters, such as financial relations with health care professionals, anti-corruption and sunshine rules. Furthermore, Hein helps companies with pricing and reimbursement matters in the Netherlands as well as with Dutch government investigations and enforcement measures.

Hein represents clients in EU and Dutch regulatory litigation beforethe Dutch administrativelaw courts, civil law courts and the Court of Justice of theEuropean Union (CJEU) as well as beforeself-regulatory industry bodies and regulatory authorities. Hein is also a member of the global steering committee of thefirm's Geopolitical Risk and National Security platform, which brings together experts within Hogan Lovells to advise global business on shifts in geopolitics and theincreased use of national security measures by governments around the world.

Advising innovator pharmaceutical and biotechnology companies on EU regulatory data protection,EU orphan marketexclusivity and theinterplay of thoseregulatory incentives with patents. Advising innovator pharmaceutical and biotechnology companies on theimplications of theEU PharmaLaw 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 preparefor EMA PV inspections. Defending companies in administrativelaw litigation againstenforcement 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 beforeindustry codecommittees and before thecourts.