Carla Schoonderbeek

Partner at Arnold & Porter

Speaker

Carla Schoonderbeek is a Partner at Arnold & Porter and is based in Amsterdam. Carla has extensive experience in European law as it pertains to the regulation of medicinal products, both pharmaceuticals and biologicals. She provides advice on and litigates before the European and national Courts about EU and national marketing authorisations and EU regulatory exclusivities such as EU regulatory data protection, orphan market exclusivity and paediatric rewards. In addition she advises on the application of the Paediatric Regulation including the submission of PIPs and applications for waivers or deferrals and the Orphan Regulation including orphan designation and derogation as well as on pharmacovigilance matters including enforcement actions by the competent authorities both at EU level and at the national level of Member States.