Insights and Analysis
AI-washing – when AI hype becomes a litigation risk
Caroline Schmalenbach
Senior Associate Global Regulatory
Languages
English, German
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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), Caroline Schmalenbach specializes in providing legal advice to national and international pharmaceutical companies, medical device manufacturers and other players in the innovative life science industry on complex contractual, regulatory and strategic issues in all phases of drug and medical device development.
She provides legal advice, in particular, on the drafting and negotiation of commercial agreements, especially in the area of research, development, manufacturing and supply. She also provides comprehensive advice on IP-related issues such as licensing and assisting clients with the legal assessment and implementation of these matters. In addition, she regularly reviews and negotiates clinical trial agreements. She also helps clients to identify and mitigate compliance risks in collaborations with health care professionals. Her extensive expertise in providing legal advice on the marketing and advertising of medicinal products, particularly prior to market launch, and medical devices makes her a trusted advisor for a large number of clients. She frequently collaborates closely with her life sciences colleagues in the EU and the US, while also working across practices with experts in areas such as M&A, antitrust, and data privacy. This interdisciplinary approach enables her to deliver tailored and comprehensive solutions to her clients.
During her legal training she gained experience in several international major commercial law firms.
Representative experience
Secondment during ten months at a global pharmaceutical manufacturer in the range of innovative pharmaceutical production for third-party companies; focus: contractual advice re framework agreements.
Comprehensive advice to a medical device manufacturer regarding regulatory and compliance matters in connection with distribution and invoicing their products.
Providing legal advice on the marketing and advertising aspects of a pharmaceutical company as well as a global medical device manufacturer.
Advising leading German pharmaceutical companies regarding regulatory issues of an authorization.
Advising a biotech company on litigious and non-litigious disputes with a Dutch contract manufacturer.
Supporting a US biotech start-up in its growth into a pharmaceutical manufacturer, focusing on the review and negotiation of manufacturing and supply agreements for an innovative cancer drug.
Assisting AbbVie GmbH in filing a constitutional complaint against the price and reimbursement restrictions of the German Act for the Financial Stabilisation of Statutory Health Insurance.
Advising Fresenius Kabi AG in connection with the divestment of a pharmaceutical production facility in Norway.
Comprehensive advice to a US biotech company regarding communication in a scientific context about a drug that has not (yet) been approved in the European market (pre-approval marketing).
Drafting of a licence, manufacturing and supply agreement for an innovative pharmaceutical product for a global life science company.
Credentials
Education
- Second State Exam in Law, Hanseatic Court of Appeals, 2022
- First State Exam in Law, University of Hamburg, 2020