Els Janssens

Els Janssens

Counsel
Baker & McKenzie CVBA/SCRL

Biography

Els Janssens is a Counsel in commercial law, litigation and healthcare regulatory issues in the Brussels office.

Els worked as a senior regulatory legal counsel for Johnson & Johnson supporting the company's global safety operations and advising on regulatory issues in relation to specific medicinal products.

Els also worked as legal advisor in the European Medicines Agency where she advised management, scientific committees, CMD(h) and the European Commission on a wide variety of issues in connection with authorisation procedures, submission requirements, pharmacovigilance obligations and procedures as well as inspections.

Based in Abu Dhabi from 2014 to 2019, she advised both multinational medical devices and pharmaceutical clients on healthcare regulations in the EU and UAE.

Practice Focus

Els advises multinational pharmaceutical clients and investors on healthcare regulations in the EU and UAE. She equally supports the global healthcare group of the firm with knowledge management for the healthcare sector.

Representative Legal Matters

  • Advised Sequana Medical NV on regulatory aspects in IPO process.
  • Advised Korys NV on regulatory aspects related to acquisition of Newpharma (online pharmacy business).
  • Advised a Belgian biotech focused on women's health on regulatory aspects in context of contemplated IPO.
  • Advised a Belgian biotech focused on immunotherapeutics on regulatory aspects in context of contemplated IPO.
  • Advised Carnegie Investment Bank AB on regulatory aspects in context of IPO of Q-Linea AB.
  • Seconded to Cleveland Clinic Abu Dhabi (a Mubadala company) to provide support with commercial contracts, compliance and setting up the internal legal function.
  • Assisted UK biotech company with regulatory aspects of Brexit strategy.
  • Advised US pharmaceutical and medical devices companies on regulatory aspects of Brexit.
  • Advised EFPIA on legal/regulatory aspects of European Commission's proposal on Health Technology Assessment (HTA).
  • Assisted EFPIA with coordination of a survey on confidentiality rules applicable in various EU countries for the purpose of HTA and pricing and reimbursement procedures as well as joint procurement.

Admissions

  • Brussels~Belgium (2000)
  • Antwerp~Belgium (1999)
  • Dubai - Registered Legal Consultant

Education

  • 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

Author, "Report on Medication Errors", EJRR (European Journal on Risk Regulation), volume 4, number 3, p. 388, 2013

Co-author, "Traité de Droit Pharmaceutique - La commercialisation des medicaments á usage humain en Belgique", Kluwer, 2011

Co-author, "Promoting Medical Products in Europe and North America", second edition, edited by Thilo Räpple, Baker McKenzie, 2007