JOSEFINE SOMMER is an experienced EU life sciences regulatory, compliance and enforcement lawyer, as well as a Medical Device Quality Systems Lead Auditor. Josefine advises a broad range of clients within the life sciences industry, including medical device, in vitro diagnostics, digital health, pharmaceutical, biotechnology and food companies. She also advises clients on EU environmental law, including chemicals legislation.
Josefine advises clients on regulatory and compliance issues pertaining to the pharmaceutical industry with a focus on clinical trials. She co-leads Sidley’s benchmarking group for in-house clinical trial lawyers (ctlegal), and drawing on her in-depth knowledge of global GCP practices she provides strategic advice in relation to GCP inspections and more generally, to companies facing regulatory or enforcement measures by regulatory authorities affecting their business.
Clients value Josefine’s extensive practical experience and pragmatic legal advice on regulatory compliance and Notified Body interactions. She regularly supports companies in responding to Notified Body audits and regulatory authority inspections. A qualified ISO 13485 (medical devices – quality management system) Medical Devices Lead Auditor, her extensive knowledge of the EU Medical Devices Regulation and In Vitro Diagnostics Medical Devices Regulations is complementary to her experience in clinical investigations and technical files.
Drawing on her regulatory expertise, Josefine regularly conducts EU regulatory due diligence for private equity and M&A transactions, making strategic recommendations on areas of potential risk.
Josefine also advises clients on EU environmental law, including chemicals legislation in relation to the manufacture, import, use – and phasing out – of chemicals in medical devices, consumer products and biocidal products.
Josefine is a co-founder of the Women’s Life Sciences Network (WLSN), a platform for high-level discussion of life sciences law and policy developments. This successful international networking group was established for female life sciences regulatory professionals to facilitate and strengthen informal contact among women professionals in the field.
She is a board member of W@LifeSciences, a reference platform for women professionals working in the Life Sciences industries.
Josefine is featured in “Rising Stars - Life Sciences” of Legal Media Group's Expert Guides 2019.