Anna-Shari Melin
Food, Drug and Medical Device
Environmental, Social and Governance
Biography
ANNA-SHARI MELIN is a leader of the Global Life Sciences practice in Munich. Her practice combines EU and German regulatory, compliance, environmental, social and governance (ESG) as well as private equity/M&A experience. Her clients include pharmaceutical, biotechnology, medical device, food, cosmetic, and other consumer goods companies.
Anna has vast experience in product lifecycle multijurisdictional regulatory matters. Her clients value her analyses and strategy/risk assessments in relation to clinical trials, GMP compliance, early access programs, pharmacovigilance, supply chain management including shortages prevention, product recalls, marketing and advertising, interactions with healthcare professionals and related compliance, as well as due diligence for life sciences transactions. Anna has advised several international clients, including U.S. food supplement clients, on strategic market entry in Germany and the EU.
Anna has represented clients in matters before the European Commission, the European Medicines Agency, the European Court of Justice and the German Federal Court of Justice (Bundesgerichtshof), for example in pay-for-delay appeals.
Anna co-leads Sidley’s benchmarking group for in-house pharmacovigilance lawyers (pvlegal) and regularly speaks on timely pharmacovigilance topics. She also co-leads Sidley’s Life Sciences ESG Roundtable, a discussion forum for in-house counsel to exchange in relation to the EU’s evolving sustainability/ESG legislative framework.
Prior to joining Sidley, Anna was an associate at international law firms in Brussels.
Experience
Representative Matters
- Crown Bioscience in its acquisition of the IndivuServ business unit of Indivumed GmbH.
- Gilde Healthcare in its acquisition of SDS Group.
- Advising RTI Surgical Inc. in its contemplated acquisition of a provider of spinal implant solutions that serve to address the unmet clinical needs of spine surgeons and their patients.
- Advising client on contemplated acquisition of leading specialty generics company.
- Advising a premier designer, developer, and manufacturer of medical devices focused on preventing infections and supporting patients and caregivers across the acute care markets on its asset purchase of a medical restraints manufacturer active on the EU and in particular the German market.
- Advising a U.S.-based multinational medical devices and healthcare company under EU and German law with respect to various aspects of their business, including the disposal of medical devices under relevant electronic waste and infectious disease laws; pricing and advertising strategies prior to obtaining CE marking; and licensing requirements applicable to a broker company manufacturing pet food from medicinal product scraps.
- Counselling one of the largest Japanese pharmaceutical companies under EU and German law relevant to early access programs, including on agreements with German university hospitals covering the provision of a monoclonal antibody in the context of an individual treatment attempt.
- Advising a Germany-based multinational company in the context of an FCPA/anti-corruption risk assessment of operations in various EU countries.
- Advising an EU multinational food-products corporation on EU and German law relevant to the labelling, manufacture and reimbursement of infant formula and follow-on products.
- Counselling a global alternative asset manager on in its due diligence process while acquiring a company focused on medicines for the central nervous system.
Community Involvement
Membership & Activities
- Munich Bar Association (Rechtsanwaltskammer München).
Pro Bono
Anna-Shari is involved in the firm’s Emerging Enterprises Pro Bono Program, which provides free legal support to eligible small- and medium-sized for-profit enterprises and market-focused non-governmental organizations and non-profits that have a clear social impact in developing countries across Africa, Asia, Central and South America, and the Caribbean. Anna has advised organizations such as the Wildlife Justice Commission and She Trades at the International Trade Centre (ITC).
Credentials
- Germany – Attorney at Law
- University of Goettingen, First State Exam, 2013
- Vriolg Olivier Brand, Higher Regional Court of Braunschweig, Germany (2014-2015)
- 英文
- German