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 | |
|---|---|---|
 | Violeta Stoyanova-Beninska (Chair) | Senior Scientific Specialist, Office of Therapies for neurological and psychiatric disorders, European Medicines Agency, The Netherlands |
 | Oxana Iliach (Vice Chair) | Senior Director Regulatory Strategy, Certara, Canada |
 | Ana Hidalgo-Simon | Associate Professor at Leiden University Medical Center, The Netherlands |
 | Anneliene Jonker | Assistant Professor in Rare Diseases Therapeutic Innovation, University of Twente, The Netherlands |
 | Caroline Pothet | Head of Advanced Therapies, Human Medicines Division, European Medicines Agency, The Netherlands |
 | Daniel O'Connor | Executive Director Regulatory and Early Access Policy, The Association of the British Pharmaceutical Industry, UK |
 | Francesca Buttigieg | Regulatory Affairs Executive Director, RhyGaze AG, Switzerland |
 | 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 | Executive Director - Global Program Regulatory Director, Novartis, USA |
 | Marco Rizzi | Associate Professor of Law, University of Western Australia, Perth, Australia |
 | Marie Christine Ouillade | AFM Téléthon, France |
 | Michela Gabaldo | VP ATMP Global Regulatory Affairs, Evotec, Italy |
 | Reda Jundi | Pfizer Saudi Arabia Cluster Lead Regulatory, Saudi Arabia |
 | Silvia Cerolini | CEO, Eyes on the Future, UK |
