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Cloud-Driven Transformation: Empowering Pharma Industry and Regulators
Session Chair(s)
Vada Perkins, MS
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)
Vada Perkins, MS
Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
US FDA/Industry Regulatory Cloud Research Collaboration: Project PRISM (PrecisionFDA Regulatory Information Service Module)
Ginny Hussong
Branch Chief, Data Standards, CBER, FDA, United States
FDA Update
Ron Fitzmartin, MBA
Principal Consultant, Decision Analytics, United States
Delivering a Data-Driven ICH M11 Clinical Protocol Template
Hilmar Hamann, PHD
Chief Information Officer, European Medicines Agency, Netherlands
Cloud-Driven Transformation: Enabling the Ambition of a Global Pharmaceutical Quality Knowledge Management Capability
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