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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
Lexeo Therapeutics, United States
Vice President, Regulatory Affairs
Digitalisation in Regulatory Systems: Industry Perspective
Rodrigo Palacios, MBA
F. Hoffmann-La Roche, Switzerland
Executive Director, Technical Regulatory Policy
RWE in Regulatory Decision Making
Gracy G Crane, PhD, MS
Roche, United Kingdom
Policy Lead