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Session 0207: INTERNATIONAL REGULATIONS - NEW INITIATIVES
Session Chair(s)
Janet Lu, MS, RPh
Head of Regulatory Asia Pacific
Roche , China
Adaptive licensing, break-through designation & approval in US, and the implementation of EU new Clinical Trials Regulation (CTR) are hot topics discussed by both regulatory agencies and industry. This session would provide the most recent updates on those initiatives and their impacts.
Speaker(s)
Adaptive Licensing
Lisa Tan, PhD
Health Sciences Authority, Singapore, Singapore
Deputy Director
US Breakthrough and Oncology New Regulations/Policies
Michelle Rohrer, PhD
Roche, United States
Senior Vice President, Global Head of Product Development Regulatory and Policy
EU New Initiatives
Anette Hjelmsmark, MS
Novo Nordisk A/S, Denmark
Senior Regulatory Intelligence Manager
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