The Funders Constituent Committee (FCC), the Companies Constituent Committee (CCC) and the Regulatory Scientific Committee (RSC) are establishing a Task Force on International Regulatory Convergence aiming to identify barriers towards mutual recognition of the approval of rare disease therapies by different jurisdictions and propose concrete solutions.
The Task Force will follow a disease agnostic approach and focus on early stage development for Advanced Therapy Medicinal Products, in particular cell and gene therapies. Keeping in mind the differences across jurisdictions, the Task Force proposes to assess how convergence could be facilitated with the aim to accelerate therapeutic development and approval of medicines for rare diseases across the globe.
IRDiRC is looking for members to populate this Task Force with the above expertise and experience in the following areas:
- Regulatory Science
- Regulatory affairs
- Health Technology Assessment and Appraisals
- Research Funding
- Patient Advocacy
- Development of cell and gene therapies for rare diseases
- Design of Clinical Trials especially will less frequently used designs
- Effective use of real world data and other data sources
- Chemistry, Manufacturing and Controls
The call for candidates is open to experts from around the globe.
Engagement into the Task Force will require voluntary time commitment. The usual time commitment includes monthly 1-hour teleconferences, one face to face workshop (1-1.5 days), regular email correspondence and collaborative working, with the opportunity to co-author peer reviewed article(s) and present potential guidance to regulators.
If you are interested in taking part in this activity, please send a CV, biosketch and letter of motivation to the Scientific Secretariat scientific.secretariat[at]irdirc.org before the 9th of February 2025.
Please add in the subject of your email the reference for this call Ref: TF-RegConv.
Only selected candidates will be contacted.