Josefine Sommer

Partner at Sidley Austin

Speaker

JOSEFINE SOMMER is an experienced EU regulatory and compliance lawyer, advising pharma, biotech, and medical device clients on complex aspects of product life cycle management under EU law. Josefine also advises investors in relation to the regulatory due diligence for transactions. As a Medical Devices Quality Systems Lead Auditor, she supports clients in inspection and audit matters as well.

Josefine advises the life sciences industry, covering pharmaceuticals and biotech, medical devices and IVDs, digital health and combination products, as well as cosmetic food.

Medical Devices, Digital Health, and AI: Medical devices and IVD clients value Josefine’s extensive experience and commercial legal advice on regulatory compliance with EU medical devices and IVD requirements. Josefine advises clients on applying a practical and business-oriented approach and she regularly supports companies in responding to safety or compliance-related interactions with health authorities and Notified Bodies. Josefine co-leads Sidley’s benchmarking group, mtlegal, for in-house medical devices and IVD lawyers.

Clinical trials and GCP: Building on many years of experience, Josefine supports EU clinical trials sponsors on all aspects of GCP compliance in the EU. She supports clients on various GCP-related issues, such as serious breach assessments and notifications, unblinding considerations, post-trial access, as well as named patient and compassionate-use programs. Josefine advises client on issues relating to disclosure of clinical trials data, and she helps clients conduct pre-inspections readiness trainings and she supports clients in inspection responses.

Drug Regulations: Josefine supports clients in the drug life cycle, including EU regulatory aspects relating to marketing authorizations, and she frequently advises on relevant EMA procedures. In addition, she advises on EU regulatory and codes of practice-related rules on advertising and promotion of medicinal products, medical devices, and IVDs. Her experience includes the use of social media and influencers.

GMP and QMS: Josefine provides strategic advice to clients on GMP inspections and compliance with EU GMP requirements for pharmaceutical, biotech and medical devices, and IVD companies. Josefine is also a qualified ISO 13485 (medical devices – quality management system) Medical Devices Lead Auditor.

Novel Foods and GMO: Leveraging years of experience, Josefine advises clients on EU novel foods requirements.

Environment: 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 and IVDs, pharmaceutical and biotech products, as well as consumer products. She also advises on regulatory aspects relating to the Batteries Regulation as it impacts medical devices and IVDs.

Drawing on her broad life sciences regulatory knowledge, Josefine regularly conducts EU regulatory due diligence for private equity and M&A transactions, making strategic recommendations on areas of potential risk.

She is a board member of W@LifeSciences, a reference platform for women professionals working in the life sciences industries and co-founded Sidley’s Women’s Life Sciences Network (WLSN), a highly successful international networking forum that meets regularly to discuss high-level life sciences law and policy developments, and facilitates informal contact for female life sciences regulatory professionals.

Josefine is recognized in Legal 500 EMEA (Belgium) 2024 for EU Regulatory: Pharma, Medical Devices, and Biotech, where clients commented that she is “is a fantastic practitioner. She is extremely competent, but also available at short notice. She provides regulatory but also strategic advice. She, and her team, provide realistic timelines for project completion.”

Josefine also features in “Rising Stars – Life Sciences” of Legal Media Group’s Expert Guides since 2019. In 2022, she has been included in Law.com International’s “Rising Stars: Europe’s Best Up and Coming Female Lawyers” list.