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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.
Speaker(s)
Reflections on ICMRA Pilots and Opportunities for International Regulatory Collaboration
Sarah Pope Miksinski, PHD
Gilead Sciences, United States
Executive Director, CMC Regulatory Affairs
EMA Experience with Regulatory Reliance and Collaboration and Opportunities
Peter Richardson, PHD
European Medicines Agency, Netherlands
Head of Quality, Specialised Scientific Disciplines Department
Industry Experiences with Regulatory Reliance and Collaboration Initiatives
Joann M Parker, MPHARM
Pfizer, United States
Vice President of Regulatory CMC
FDA Reflection on Experiences with International Regulatory Collaboration and Opportunities
Representative Invited
FDA, United States
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