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Cloud-Driven Transformation: Empowering Pharma Industry and Regulators
Session Chair(s)
Vada A. Perkins, DrSc, MSc
Vice President, Global Head of Regulatory Intelligence & Policy
Boehringer Ingelheim, United States
This forum will identify how cloud-based technologies may be utilized to promote interactive and collaborative regulatory review (applicant-regulator; inter-regulator) both regionally and internationally. Speakers will discuss several regulatory use cases and initiatives that are leveraging these technologies to modernize data exchange and regulatory review.
Learning Objective : Illustrate how cloud-based technologies may promote interactive and collaborative regulatory review (applicant-regulator; inter-regulator) both regionally and internationally discussion of several regulatory and scientific use cases opportunities leveraging cloud-based solutions; Discuss relevant PDUFA VII provisions and FDA’s public-private partnerships and European Medicines Agency initiatives in advancing regulatory science through the application of cloud technology.
Speaker(s)
US FDA/Industry Regulatory Cloud Research Collaboration: Project PRISM (PrecisionFDA Regulatory Information Service Module)
Vada A. Perkins, DrSc, MSc
Boehringer Ingelheim, United States
Vice President, Global Head of Regulatory Intelligence & Policy
FDA Update
Ginny Hussong
FDA, United States
Branch Chief, Data Standards, CBER
Delivering a Data-Driven ICH M11 Clinical Protocol Template
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Advisor, Office of Regulatory Operations, CBER
Cloud-Driven Transformation: Enabling the Ambition of a Global Pharmaceutical Quality Knowledge Management Capability
Hilmar Hamann, PhD
European Medicines Agency, Netherlands
Head of Information Management
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