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Harnessing International Regulatory Reliance and Collaboration to Accelerate Innovation and Patient Access to Medicines
Session Chair(s)
Amanda Roache, MS
Deputy Vice President, Science and Regulatory Advocacy
PhRMA, United States
Sponsors are increasingly leveraging regulatory collaboration and reliance approaches. In this Forum, international regulatory and industry experts will review ongoing pilot projects and discuss future opportunities.
Learning Objective : Discuss Industry experience with reliance initiatives; Explain ICMRA and ICH efforts to facilitate a pharmaceutical quality knowledge management capability; Identify benefits and challenges for expanding global regulatory reliance and collaboration; Outline how cloud-based platforms and harmonized regional requirements can strengthen reliance.
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