Els Janssens
Biography
Els Janssens is a Senior Counsel in the Brussels office, advising pharmaceutical, biotechnology, medical device and digital health companies on regulatory, market access, compliance and public affairs matters across Europe and the Middle East.
Prior to private practice, Els served as Senior Regulatory Legal Counsel at Johnson & Johnson, where she supported the company's global safety organisation and advised on regulatory issues relating to medicinal products in the EU.
Els also worked as Legal Adviser at the European Medicines Agency (EMA), advising the Agency's management, scientific committees and the European Commission on a broad range of EU pharmaceutical law issues, including scientific advice, marketing authorisation procedures, pharmacovigilance, inspections, post-market procedures and regulatory enforcement matters.
From 2014 to 2019, Els was based in Abu Dhabi, where she advised multinational pharmaceutical and medical device companies, healthcare providers and industry associations on healthcare regulation, market access, compliance and commercial matters across the Gulf region. She continues to be recognised for her extensive experience in UAE and wider GCC healthcare regulation.
Els regularly supports clients on complex regulatory strategies, clinical trials, EU pharmaceutical legislation, Health Technology Assessment (HTA), pricing and reimbursement, market entry, compliance programmes, transactions and regulatory due diligence.
Practice Focus
- EU and national pharmaceutical regulation
- EU and national medical devices and in vitro diagnostics regulation
- Health Technology Assessment (HTA)
- Pricing, reimbursement and market access
- Clinical trials and innovative therapies
- Compliance, interactions with healthcare professionals and industry codes
- Regulatory support for transactions, investments and IPOs
- Digital health related topics including EHDS
- Healthcare regulation in the UAE and GCC
- Public affairs and healthcare policy
Representative Legal Matters
- Advising EFPIA and Vaccines Europe on EU pharmaceutical, healthcare and policy-related regulatory matters.
- Advising various multinational pharmaceutical and medical device companies on the proposed revision of the EU pharmaceutical legislation and its impact on regulatory and commercial strategies.
- Advising various multinational pharmaceutical companies on implementation of EU HTA Regulation
- Advising Regeneron on regulatory and compliance aspects of commercial expansion ex-US
- Advising Lakefront Biotherapeutics on clinical development projects and related matters
- Advising Medtronic on regulatory aspects of separation of diabetes business (Minimed)
- Advising CD&R on regulatory aspects related to acquisition of Opella
Admissions
- Brussels~Belgium (2000)
- Antwerp~Belgium (1999)
- Dubai - Registered Legal Consultant
Education
- Université Catholique de Louvain (Selected courses in post-graduate education for industry pharmacist (regulatory affairs with respect to clinical trials and pharmaceutical legislation)) (2005)
- University of Lausanne (LL.M.) (1999)
- Catholic University of Leuven (Notary Public) (1998)
- Catholic University of Leuven (License Political Science) (1997)
- Erasmus University Rotterdam (M.C.L.) (1996)
- Catholic University of Leuven (Bachelor's Degree) (1994)
Languages
- Dutch
- English
Previous Offices
- Dubai