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Regulator Perspective: Maintaining GCP During Covid-19 and Beyond the Pandemic
Session Chair(s)
Paula Walker, MA
Global Head of Risk Based Quality Management
Roche, United Kingdom
Regulator panel perspective on maintaining GCP compliance during a pandemic, including challenges in remote working, good risk assessments to guide decisions, innovation to meet compliance while ensuring regulatory flexibilities are met.
Learning Objective : Describe global regulator views on issues affecting GCP compliance during a pandemic and future proofing beyond; Describe regulatory challenges such as working with the need for regulatory flexibilities and challenges in innovating to maintain compliance using remote ways of working; Discuss using good risk assessments to guide decisions.
Speaker(s)
MHRA Update
Gail Francis
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Expert Inspector, GCP
FDA Update
Barbara D Wright
FDA, United States
Supervisory Investigator, Foreign Inspection Cadre, Office of Bioresearch Monito
Danish Medicines Agency Update
Lisbeth Bregnhøj, PHD, MPHARM
The Danish Medicines Agency, Denmark
EC ICH E6(R3) Expert Working Group Member