Carla Schoonderbeek

partner

Carla Schoonderbeek has extensive experience in European law as it pertains to the regulation of medicinal products, both pharmaceuticals and biologicals. She provides advice on EU market access, including EU and national marketing authorizations, regulatory exclusivities such as regulatory data protection, orphan exclusivity and pediatric rewards, the application of the Pediatrics and Orphan Regulations, clinical trials, EU risk management plans and pharmacovigilance rules, as well as enforcement actions by the competent authorities both at EU level and at the national level. Carla’s national practice includes pricing and reimbursement, compliance matters, advertising and labeling.

  • REPRESENTATIVE MATTERS
    • Carla has litigated numerous cases before the European and national Courts. She coordinates pan-European matters and litigation with a longstanding and trusted network of specialized local counsel in various EU member states and has extensive experience in advising the industry with respect to European and national rules in Member States.
    • Carla has assisted numerous pharmaceutical companies in obtaining, maintaining or amending marketing authorizations for their products. In this context she has provided legal advice in the compiling of the application dossiers, has assisted clients in their contacts with EU and national regulatory agencies and helped them address deficiencies in their applications as identified by the authorities.
    • Carla has assisted many clients in obtaining market access through reimbursement for their products. This implies assistance in compiling an application dossier with scientific data and contacts and negotiations with regulatory authorities.
    • Carla has assisted clients with developing pharmacovigilance systems, risk management plans and risk minimization activities and the implementation thereof in accordance with national law systems throughout the EU. This included e.g. dealing with issues arising from inspections by the competent authorities and drafting safety data exchange agreements.
  • WHAT OTHERS SAY
    • “Absolutely first class” Chambers Europe 2020
    • “One of the trailblazers in life sciences. She is also acclaimed for her knowledge of the Dutch and European systems.” Chambers Europe 2020
    • Carla Schoonderbeek is “really excellent, has a great reputation across Europe and is a fantastic pharmaceutical regulatory litigator who never makes mistakes and knows what she is doing.” Chambers Europe 2019
    • The “first-class” Carla Schoonderbeek is lauded as “the regulatory queen.” Chambers Europe 2018
    • “A star in the life science field and the best in the business.” Chambers Europe 2018
    • “Proficient regulatory expert.” Legal 500 2018
    • “There is little doubt she is one of the best in the regulatory field.” Chambers Europe 2017
    • “A phenomenon.” Chambers Europe 2017
    • “She is a strong personality and gets results.” Chambers Europe 2017
    • “Very smart, quick, to the point and is very creative.” Chambers 2016
    • “She is an authority on the regulatory side of life sciences.” Chambers 2016
    • “One of Europe’s leading pharmaceutical regulatory law experts.” Chambers Global 2015
    • “One of the best in Europe and has a brilliant mix of knowledge and a sharp mind.” Chambers Global 2014

Assistant(e)

Brenda Fernandes Sequeira - Meijer

+ 31 20 592 4434

Nos bureaux

Adresse :

Rembrandt Tower, 30th Floor
Amstelplein 1
1096 HA Amsterdam
The Netherlands

Adresse postale:

P.O. Box 94361
1090 GJ Amsterdam
The Netherlands

Faits

Langues

Néerlandais, Anglais, Allemand

Formations

University of Utrecht, Master of Law

Admis

1980