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:
- Contribution to IRDiRC Task Forces and Working Groups to better address regulatory questions and increase the impact of IRDiRC activities
- Multi-stakeholder interaction to identify pathways for regulatory harmonization and foster clinical research and therapeutic development
- Identify new regulatory questions
| Name | Title 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-Simon | Associate Professor at Leiden University Medical Center, The Netherlands |
 | Caroline Pothet | Head of Advanced Therapies, Human Medicines Division, European Medicines Agency, The Netherlands |
 | Cesar Hernandez | Director General of National Health System Portfolio and Pharmacy, Spain |
 | Hanako Morikawa | Principal Reviewer, Office of Medical Devices II, PMDA, Japan |
 | Julie Vaillancourt | Policy Advisor and Rare Disease Liaison, CBER/FDA, USA |
 | Kerry Jo Lee | Associate Director for Rare Diseases, CDER/FDA, USA |
 | Marie Christine Ouillade | AFM Téléthon, France |
 | Michela Gabaldo | VP ATMP Global Regulatory Affairs, Evotec, Italy |
 | Oxana Iliach | Senior Director Regulatory Strategy, Certara, Canada |
 | Reda Jundi | Pfizer Saudi Arabia Cluster Lead Regulatory, Saudi Arabia |