Carla Schoonderbeek

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 authorisations, regulatory exclusivities such as regulatory data protection, orphan exclusivity and paediatric rewards, the application of the Paediatrics 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 labelling.