JOSEFINE SOMMER focuses on EU life sciences regulatory, compliance and enforcement work. She advises clients on European Law relevant to pharmaceutical products, software medical devices, digital health products as well as novel foods and chemicals.
In particular, Josefine counsels clients on regulatory and compliance issues pertaining to the pharmaceutical industry with a focus on clinical trials, and good practice (GxP), in particular good clinical practice (GCP) and advertising and promotional issues. She also advises clients on imports into the EU of active pharmaceutical ingredients (APIs) and provides strategic advice to companies facing regulatory or enforcement measures by regulatory authorities affecting their business.
Josefine also regularly advices on EU regulatory due diligence for private equity firms and life sciences clients. She works closely with Sidley’s Private Equity, M&A and Technology and IP Transactions groups to provide clients with integrated and pragmatic regulatory advice, making strategic recommendations on areas of potential risk.
In addition, she advises clients on the changing landscape for regulatory requirements related to medical devices and in vitro diagnostics, from clinical investigations and technical files, to classification and qualification of devices and advertising and promotion. Josefine is a qualified ISO 13485 (medical devices – quality management system) Lead Auditor.
Josefine also 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.
Josefine is featured in “Rising Stars - Life Sciences” of Legal Media Group's Expert Guides 2019.
In 2014, Josefine co-founded the Women’s Life Sciences Network (WLSN), a successful international networking group established for female life sciences regulatory professionals. The WLSN regularly organizes events in Europe and was born out of a desire to foster exchanges between like-minded female professionals in the Life Sciences industry. The objectives of the network are to provide a platform for high-level discussion of life sciences law and policy developments, facilitate and strengthen informal contact among women professionals, and mentor and promote the advancement of women in the field.