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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 Products Ltd., 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 Bregnhoj, PhD, MPharm
Danish Medicines Agency (DKMA), Denmark
Medicines Inspector, GCP
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