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Adem Koyuncu
Dr. Dr. Adem Koyuncu
Brussels +32 2 549 5240 Download V-card

Adem Koyuncu is a German Rechtsanwalt and a partner in the life sciences practice.  Dr. Koyuncu is double qualified as a lawyer and medical doctor.

Dr. Koyuncu advises clients on a broad range of EU and German law regulatory issues that affect pharmaceuticals, medical devices and other health and consumer products. His practice further covers compliance, privacy and liability matters and he also assists clients in transactions and IPOs.

  • Advised on regulatory requirements for drug distribution, marketing authorisations, market/data exclusivity, pharmacovigilance, clinical trials, GCP, GVP, GDP and GMP.
  • Medical devices distribution and regulatory compliance, obtaining CE marks and vigilance issues.
  • Advice on off-label-use of medical devices and drugs as well as “named patient use” and compassionate use programs.
  • Litigation before German courts (e.g., unfair competition, IP, liability cases).
  • Advice on product recalls with representation in product liability litigation and settlement negotiations.
  • Research with human biomaterial and biobanks and related data protection and contractual issues.
  • Numerous matters on advertising for drugs and medical devices, including unfair competition litigation.
  • Advised on organizational compliance in pharmacovigilance.
  • Advised on legal requirements for mobile health apps and telemedicine systems.
  • Advised on various aspects of market access, pricing and reimbursement for drugs and medical devices (including AMNOG, NUB).
  • Advised several clients in the establishment of company-wide compliance programs.
  • Internal investigations in cases with (1) suspected anti-corruption issues and (2) suspected violations of regulatory and privacy requirements for clinical trials.
  • Representation of clients in proceedings against distribution of counterfeited products.
  • Advised a US medical devices manufacturer in the acquisition of a German devices distribution company.
  • Regulatory and compliance due diligences in several transactions and IPOs.

Memberships and Affiliations

  • Member of the Law360 Life Sciences Editorial Advisory Board
  • Member of the Ethics Committee of the University of Dresden
  • Associated Member of the "Legal Working Group" (Arbeitskreis Recht) of BVMed, the German Medical Devices Industry Association
  • Different Working Groups in EUCOPE (European Confederation of Pharmaceutical Entrepreneurs)
  • Vice-Chair of Legal Working Group of EUCOPE (European Confederation of Pharmaceutical Entrepreneurs) 
  • Member of the “Life Science Committee” of the DVFA (Society of Investment Professionals in Germany)
  • Society for Law and Politics in Health Care (GRPG)
  • German Society for Medical Law (DGMR)
  • Visiting Lecturer at the Bucerius Law School, Hamburg, and the University of Düsseldorf
  • Member of the Editorial Boards of the following Legal Journals:
    • Pharma Recht (Pharma Law)
    • Medizinprodukte-Recht (Medical Devices Law)

Previous Experience

  • Partner and co-head of the global Life Sciences-group at an international law firm.
  • Drug safety advisor in an international pharmaceutical company.
  • Member of the Ethics Committee of the University of Dresden.
  • Expert in several hearings before the German Parliament (health committee) on medical devices law (June 2012) and on pharmaceutical law (May 2016).
  • “Life Sciences Star” in LMG Life Sciences Europe 2014-2015
  • Who’s Who Legal: Life Sciences 2016
  • Chambers Europe
  • JUVE
  • Legal 500
  • PLC Which Lawyer?
  • Deutscher Arzt Recht Preis 2008 (German Medical Law Award)
  • Wissenschaftspreis im Gesundheitswesen 2005 (Science Award in Health Care)