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Session 7: Innovative Approaches in Medicine Developments
Session Chair(s)
Hala Abu-Ghazalah, RPH
Head of Regulatory Affairs, Africa Middle East, Pfizer, United Arab Emirates
Nevena Miletic
IFPMA ARN Chair Advisor and Regulatory Policy & Science Chapter Leader, F. Hoffmann-La Roche Ltd, Switzerland
• Personalised Medicine o Patient Perspective o Use of novel endpoints Clinical Development o RWE • Digitalisation in Regulatory Systems o E-Submission
Speaker(s)
Keith Wonnacott, PHD
Vice President, Regulatory Affairs, Lexeo Therapeutics, United States
Digitalisation in Regulatory Systems: Industry Perspective
Senior Director, Technical Regulatory Policy, F. Hoffmann-La Roche Ltd., Switzerland
RWE in Regulatory Decision Making
Policy Lead , Roche, United Kingdom
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