AI-washing – when AI hype becomes a litigation risk
Dr. Sophie Victoria Kaminsky
Associate
Languages
German, English
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Overview
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Experience
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Credentials
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Insights and events
As a member of the SOAR team (Strategic, Operations, Agreements, and Regulation), Sophie Kaminsky specializes in providing comprehensive legal counsel to national and international pharmaceutical companies, medical device manufacturers, and other players in the innovative life sciences industry.
Sophie's practice focuses on advising clients on complex regulatory and strategic issues across all phases of drug and medical device development, from initial studies and the development process through to market approval and post-market regulatory compliance. Further she possesses practical expertise in marketing compliance and interactions with healthcare professionals are related HCP/ABAC compliance. Sophie also advises on the drafting and negotiation of clinical trial agreements and commercial contracts.
Sophie already had her focus on medical law during her studies. Building on this foundation, she delved deeper into biomedical legal issues as part of her dissertation. During her time as a legal trainee, she gained valuable experience at a major international law firm dealing with regulatory issues in food, pharmaceutical, and medical device law.
Representative experience
Advising a German healthcare company on the product classification of a plasma-derived product and the compliant advertising and placing on the market in Germany.
Advising a US biotech company on the different options, obstacles and legal pathways for several early access of a cancer product and advice on compliant supply and communication set-up.
Review of promotional material for tissue product and a specific campaign across 12 European markets.
Representing a US based biotech company in a court proceeding against a defendant who produced and sold copycat products.
Advising a US pharma company on inviting (non‑)HCPs to research, medical/scientific, and other conferences, covering legal requirements on employer involvement, transparency, and internal approvals.
Advising on the handling and dissemination of samples and demo products and required compliance procedures.
Advising an international pharma company on the enforcement of regulatory compliance and compliance of promotional materials of a competitor.
Advising an international life sciences company on employee programs for medicinal products.
Advising a specialized logistics company on a cooperation agreement with an international biologics company.
Credentials
Education
- Second State Exam in Law, Higher Regional Court of Munich, 2025
- Dr. iur., Doctorate in Law, LMU Munich (Ludwig-Maximilians-Universität München), 2024
- First State Exam in Law, LMU Munich (Ludwig-Maximilians-Universität München), 2021