The European Regulations for Orphan Medicinal Products have been successfully implemented in the EU. Many companies have used or are using these regulations as is demonstrated by the high number of applications to the COMP. Only a limited number of products with Orphan Medicinal Product Designation have reached the market.
Hélène Sou, Anne-Virginie
2009 - RAPS Career Book
Chapter RAPS: Working as an Independent Consultant in Regulatory Affairs
Hélène Sou, Project Leader
Hélène Sou participates in the preparation and management of registration applications both in the European Union (EU) and the USA, for drugs, biologics and medical devices. She has been involved in the preparation and follow-up of several successful applications. Hélène liaises with regulatory agencies on a regular basis to streamline the registration process and works with Experts to write Expert Statements and Expert Reports.
Anne-Virginie Eggimann, Executive Director
She focuses on the development of drugs and biologics services, including for cell and gene therapies. She has expertise in and works on the design and implementation of science‑based regulatory strategies. She manages multidisciplinary teams dedicated to complex and innovative medicinal products development, at all stages, including for personalized medicine.