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Monday, June 17 • 11:00am - 12:00pm
#107: Cloud-Driven Transformation: Empowering Pharma Industry and Regulators

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-521-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Vada A. Perkins, DrSc, MSc

Speaker

US FDA/Industry Regulatory Cloud Research Collaboration: Project PRISM (PrecisionFDA Regulatory Information Service Module)
Vada A. Perkins, DrSc, MSc

FDA Update
Ginny Hussong

PRISM Use Case: ICH M11 Protocol
Ron Fitzmartin, PhD, MBA


Speakers
avatar for Vada Perkins

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of Regulatory Operations, CBER, FDA, United States
Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory... Read More →
avatar for Virginia Hussong

Virginia Hussong

Branch Chief, Data Standards, CBER, FDA, United States
Ginny serves as Chief of CBER's Data Standards Branch, where she leads a multidisciplinary team that advances standards such as eCTD, CDISC, IDMP, ICSR, SPL and related terminologies. In addition, conducts technical validation of clinical study data, leads related reviewer training... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Tech, Forum