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.)
Michelle Cheng is currently the Regional Therapeutic Area Head for Neuroscience, Eyecare and Specialty at AbbVie where she overseas regulatory activities in China, Japan, Australia and the Asia Region. Michelle has over 20 years of experience in the pharmaceutical industry across functions such as medical affairs, pharmacovigilance and quality assurance, in addition to regulatory affairs.
In her previous role at Novartis, she supported the first ACCESS application involving 4 countries in 2020 amongst other multi-way work-sharing initiatives and represents the Singapore Association of Pharmaceutical Industries (SAPI) as a core member of the ACCESS Consortiums’ Industry Association Committee. Michelle believes in the power of partnering and often contributes to private-public dialogue and partnership between the industry and governments. She is equally passionate about driving regulatory innovation and change management with the aim of bringing life changing therapies to patients.
Session objectives:
