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.)
Freddie Foo, MSc, is CMC Team Lead and Regulatory Consultant at the Therapeutic Products Branch of the Health Sciences Authority (HSA) of Singapore.
A senior quality assessor with over 20 years of experience in pharmaceutical quality assessment and biologics manufacturing, Freddie leads quality assessments for new and generic drug applications, while representing HSA in multiple international regulatory initiatives including ICH Q11 and Q3E, and the Access Consortium’s New Active Substance Working Group.
Prior to joining HSA, Freddie gained valuable industry experience at A-Bio Pharma, where he was part of the team which successfully optimised downstream purification processes for major clients.
Session objectives: