Carla Schoonderbeek has extensive experience in European laws regulating pharmaceutical and biological medicinal products. Ms. Schoonderbeek advises on EU and national marketing authorizations; EU 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 GMP/GDP and pharmacovigilance rules. Additionally, her practice includes EU Market access, including pricing and reimbursement, blood and tissue regulations, off-label use and compounding, compliance matters, advertising, and labelling. Ms. Schoonderbeek also represents clients of all sizes in enforcement actions by the competent authorities both at the EU and national levels.
The Legal500 calls her “a standout” and Chambers Europe, where she is recognized in Band 1, says she is known as “a great lawyer with a good network . . . [who] knows a lot about pharmaceutical regulation, but also has a broader bird’s-eye view.”
Other reviews over the past years include the following comments:
- “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 Europe 2016
- “She is an authority on the regulatory side of life sciences.” Chambers Europe 2016
- “One of Europe’s leading pharmaceutical regulatory law experts.” Chambers Europe 2015
- “One of the best in Europe and has a brilliant mix of knowledge and a sharp mind.” Chambers Europe 2014
- Multiple clients in litigating cases before the European and national courts concerning the authorisation of medicinal products and/or the enforcement of regulatory exclusivities, including coordinating pan-European matters, developing and maintaining a longstanding and trusted network of specialized local counsel in all EU/EEA member states, and advising the industry with respect to European and national rules in Member States.
- Numerous pharmaceutical companies in obtaining, maintaining or amending marketing authorizations for their products, including advising on obtaining regulatory exclusivities associated with such marketing authorizations, assisting on contacts with EU and national regulatory agencies, and helping address authority-identified deficiencies in applications.
- Many clients in obtaining market access through reimbursement for their products, including helping compile application dossiers with scientific data and contacts and negotiating with regulatory authorities.
- Clients in developing and implementing pharmacovigilance systems, risk management plans and risk minimization activities in accordance with national law systems throughout the EU, including handling issues arising from inspections by the competent authorities and drafting safety data exchange agreements.
- LL.M., University of Utrecht, 1979