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Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence: An Industry and Regulatory Agency Experience
Session Chair(s)
Dominique Lagrave, PharmD
Senior Vice President of Regulatory Innovation
Accumulus Synergy, United States
This forum will discuss regulatory activities and technology to enable global convergence and reliance for post-approval changes (PAC). Diverse panelists will share examples of efficient collaboration and information exchange to reduce the PAC process cycle times.
Learning Objective : Recognize the importance of global collaboration to support sovereign decision making; Discuss how building in reliance practices into cloud-based solutions could accelerate the post-approve changes (PAC) process globally; Explain how cloud solutions support transparency, trust, regulatory convergence, and information exchange, and collaboration to increase patient access to therapies.
Speaker(s)
Panelist
Samvel Azatyan, MD, PhD
World Health Organization (WHO), Switzerland
Team Lead, Regulatory Convergence and Networks (RCN/REG)
Panelist
Susanne Ausborn, PhD
Roche, Switzerland
Global Head International Regulatory Policy
Panelist
Debra Yeskey
CEPI, United States
Head of Regulatory Policy and Intelligence
Panelist
Cynthia Ban
Sanofi, Canada
Global Head, Regulatory Affairs CMC, Vaccines
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