Regulatory Scientific Committee

The Regulatory Scientific Committee (RSC) has been established in year 2022 to address the regulatory gaps created by the fast moving pace of rare disease innovation and therapeutic development. The RSC includes experts from around the world, representing multiple geographies and stakeholders from regulatory bodies, patient groups, biotech and pharmaceutical industry, public and non-for-profit organizations, clinicians and scientists.

The mandate of the RSC will be divided into three key actions:

  1. Contribution to IRDiRC Task Forces and Working Groups to better address regulatory questions and increase the impact of IRDiRC activities​ 
  2. Multi-stakeholder interaction to identify pathways for regulatory harmonization and foster clinical research and therapeutic development​ 
  3. Identify new regulatory questions   
 NameTitle and Organization
Anne Pariser (Chair)VP, Medical and Regulatory Affairs at Alltrna, USA
Violeta Stoyanova-Beninska (Vice Chair)Chair of Committee for Orphan Medicinal Products, EMA, The Netherlands
Ana Hidalgo-SimonAssociate Professor at Leiden University Medical Center, The Netherlands
Caroline PothetHead of Advanced Therapies, Human Medicines Division, European Medicines Agency, The Netherlands
Cesar HernandezDirector General of National Health System Portfolio and Pharmacy, Spain
Hanako MorikawaPrincipal Reviewer, Office of Medical Devices II, PMDA, Japan
Julie VaillancourtPolicy Advisor and Rare Disease Liaison, CBER/FDA, USA
Kerry Jo LeeAssociate Director for Rare Diseases, CDER/FDA, USA
Marie Christine OuilladeAFM Téléthon, France
Michela GabaldoVP ATMP Global Regulatory Affairs, Evotec, Italy
Oxana IliachSenior Director Regulatory Strategy, Certara, Canada
Reda JundiPfizer Saudi Arabia Cluster Lead Regulatory, Saudi Arabia