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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)
Gail Francis
Expert Inspector, GCP, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
MHRA Update
Barbara D Wright
Supervisory Investigator, Foreign Inspection Cadre, Office of Bioresearch Monito, FDA, United States
FDA Update
Lisbeth Bregnhøj, PHD, MPHARM
EC ICH E6(R3) Expert Working Group Member, The Danish Medicines Agency, Denmark
Danish Medicines Agency Update
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