Josefine SommerAssociate at Sidley Austin, Belgium
JOSEFINE SOMMER focuses on EU life sciences regulatory, compliance and enforcement work. She advises clients on European Law relevant to drugs, biological products and medical devices, as well as food and feed, cosmetics and other consumer goods. In particular, Josefine counsels clients on pharmacovigilance, clinical trials, marketing authorization procedures, good manufacturing practice (GMP), advertising and promotional issues, as well as procedures to commercialize medical devices. She also advises clients on imports into the EU of active pharmaceutical ingredients (APIs), clinical trial agreements, and provides strategic advice to companies facing regulatory or enforcement measures by competent authorities impeding their business. Josefine also represents life sciences clients in corporate investigations involving national anti-bribery legislation, including the U.S. Foreign Corrupt Practices Act (FCPA).
In addition, Josefine has a special focus on EU’s chemicals legislation, in particular with respect to drugs and medical devices. In particular, her work includes advising clients on the manufacture, import and use – and phasing out – of chemicals in consumer products. She also advises on the agribusiness supply chain, including pesticides, seed registration and agricultural technology. In 2014, Josefine co-founded the Women’s Life Sciences Network (WLSN), an international networking group established for female life sciences regulatory professionals.
Josefine features among the "Rising Stars – Life Sciences" of Legal Media Group’s Expert Guides 2019. Most recently, she has been shortlisted in Euromoney LMG’s inaugural Europe Rising Stars Awards for Life Sciences.
In 2015, Josefine spent several months on a secondment with a large Danish law firm in Copenhagen, Denmark.