Pharmacovigilance Agreements

ANNA-SHARI MELIN is a leader of the German 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.
She has also been semi-seconded to numerous international pharmaceutical and biotech companies, becoming a right hand to senior in-house lawyers in all their interactions with internal clients, contract partners and Member State regulatory authorities, including those in Germany and the Netherlands. Anna has trained in-house lawyers in relation to the preparation of pharmacovigilance agreements (PVAs), the roll-out of compassionate use programs in a multitude of jurisdictions and compliance with the new EU ESG framework such as the German Lieferkettensorgfaltspflichtengesetz and the proposed Green Claims Directive.
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.