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Thursday, June 27 • 9:00am - 10:15am
#409: Case Studies From FDA and MHRA: Good Clinical Practices

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Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-723-L04-P; CME 1.25; IACET 1.25; RN 1.25

If you were not able to join in person on day two of the FDA-MHRA Good Clinical Practice Workshop, Data Integrity in Global Clinical Trials – Are We There Yet? last October, and missed the case study sessions, you will have a second chance in this Workshop. Attendees will work with regulators on two of the previously presented case studies to investigate data integrity and discuss the impact of their findings on overall study reliability.

Learning Objectives

Evaluate how data management practices may impact data integrity and reliability; Discuss how data integrity is key to vendor selection; Describe and evaluate the impact of data blinding on data reliability; Evaluate how audit trails may be used to assess data integrity.

Chair

Gail Francis

Speaker

MHRA Perspective
Stephen Vinter

FDA Perspective
Jean M. Mulinde, MD


Speakers
avatar for Gail Francis

Gail Francis

Expert Inspector, GCP, Medicines and Healthcare products Regulatory Agency (MHRA)
Gail Francis joined the MHRA in November 2003 as a GCP Inspector. Prior to joining the MHRA, Gail spent approximately 10 years in the Pharmaceutical industry. Her first role in the Pharmaceutical Industry was in Pharmacovigilance, before moving into Clinical Research and has held... Read More →
avatar for Jean Mulinde

Jean Mulinde

Medical Officer, Senior Policy Advisor, OSI, OC, CDER, FDA
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products... Read More →
avatar for Stephen Vinter

Stephen Vinter

Operations Manager GLPMA and Laboratories Group, Medicines and Healthcare products Regulatory Agency (MHRA)
Stephen Vinter is Operations Manager for the GLPMA and Laboratories Group for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Prior to joining the Agency in 2012, Stephen worked in Operations Management at a Contract Research Organisation. Stephen has also... Read More →

Thursday June 27, 2019 9:00am - 10:15am
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: R-D Quality-Compliance, Workshop |   03: Data-Data Standards, Workshop