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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
Chief Regulatory Officer, Accumulus Technologies, 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
Senior Adviser, Council For International Organizations of Medical Sciences (CIOMS), Switzerland
Panelist
Global Head International Regulatory Policy, Roche, Switzerland
Panelist
Head of Regulatory Policy and Intelligence, CEPI, United States
Panelist
Global Head, Regulatory Affairs CMC, Vaccines, Sanofi, Canada
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