Jointly steering CMS’ life sciences practice, Ellen Gielen and Gertie Lintjens head a team engaged in a wide range of regulatory, commercial and contentious matters. Gielen advises on pharmaceutical and medical device regulation, including compliance, market-access pathways and reimbursement issues, while Lintjens focuses on R&D projects, early-access schemes and product-development questions. The practice is supported by Judith Kok, who regularly handles licensing mandates, distribution arrangements and product-specific regulatory issues.
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Profile
Work Department
Life Sciences & Healthcare
Position
Partner
Career
Ellen leads the regulatory practice and is an expert in regulatory, compliance and complex contractual matters and represents leading life science companies, like Amgen, Boston Scientific and Johnson & Johnson, on a range of pharmaceutical and medical device product issues, including manufacturing & distribution, pricing & reimbursement and advertising, both on domestic and EU level.
In this respect, she is renowned for developing and securing innovative partnership models in the field of "patient support programs" and "hospital solutions". Ellen is also an experienced litigator related to life sciences matters.
Languages
English, Dutch
Memberships
- Dutch Pharmaceutical Law Association
- Complaints Committee of a BOPZ Institution, an institution governed by the Psychiatric Hospitals Compulsory Admission Act
- Dutch Standardisation Institute (NEN) on MDR and IVDR topics (panel member)
Education
- Dutch Law (Company Law), Erasmus University
- Business Administration, Erasmus University
Content supplied by CMS
Key clients
- Amgen Boston Scientific Brocacef (a company of Phoenix group) Carl Zeiss Eli Lilly Essity Fagron Incyte Johnson & Johnson LEO Pharma Mölnlycke Health Care Netherlands Cancer Institute (Antoni van Leeuwenhoek) Nordmark Pharma GmbH Pharming Group N.V. Roche Sanquin Stryker Théa Pharma Thermo Fisher Vivus
Work highlights
Litigated on behalf of Leo Pharma on a landmark appeal regarding the jurisdiction of the Dutch self-regulatory court for pharmaceutical advertising.