Session objectives:
- Share high-level overview of Facilitated Product Introduction & TGA’s Regulatory Strengthening Program
- Provide platform for greater understanding of ACCESS Consortium (how it works, future plans, industry experience, etc.)
Medical Assessor at the MHRA since 2018. Expertise in areas of neurology, psychiatry, and established medicines, assessing marketing authorisation applications and providing scientific advice relating to clinical trial design and regulatory requirements. MHRA lead representative on the Access Consortium New Active Substance Working Group since 2022.
Session objectives:
