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Session 3: Innovative Processes for Regulatory Review
Session Chair(s)
Mei Ding
JAPAC Regional Lead, Policy & Intelligence
Abbvie Pte. Ltd., Singapore
Finny Liu, MSc, RPh
APAC Regional Regulatory Policy Lead
Roche, Singapore
Fast evolving new technologies as well as innovative advances create new values and bring dramatic changes to regulatory processes. COVID pandemic accelerates new initiatives, implementation in regulatory framework and reconfirm importance of collaborations between regulators across countries and regions. In this session, the latest updates about new ICH guidelines development, novel submission technology and innovative regulatory initiatives would be shared by key opinion leaders.
Speaker(s)
Expedited pathway for COVID-19 treatment/vaccine in emergency use
Mei-Chen Huang
TFDA, Taiwan
Section Chief, Division of Medicinal Products
Cloud Submission
Dominique Lagrave, PharmD
Accumulus Synergy, United States
Senior Vice President of Regulatory Innovation
Regulatory Convergence in Product Lifecycle Management: Opportunities and Challenges
Nina S. Cauchon, PhD
Amgen, United States
Director Regulatory Affairs CMC
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