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Tuesday, June 18 • 10:00am - 11:00am
#227: How to Ensure Compliance in a Changing Regulatory Environment: A Regulators Perspective

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-578-L04-P; CME 1.00; RN 1.00

Hear the thoughts of regulators regarding how they see the future direction of travel for GCP Inspections. Learn about changes to compliance strategies and collaboration initiatives which are underway or in the pipeline.

Learning Objectives

Describe challenges currently faced by regulators regarding clinical trial inspections; Discuss strategies being developed by Health Authorities including future initiatives, direction of travel, and collaborative relationships.

Chair

Jason Wakelin-Smith

Speakers
EG

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States
Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise for OSI’s policy efforts, including the development of... Read More →
avatar for Jason Wakelin-Smith

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: RD Quality-Compliance, Session