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DIA 2021 Global Annual Meeting


Regulator Perspective: Maintaining GCP During Covid-19 and Beyond the Pandemic

Session Chair(s)

Paula  Walker, MA

Paula Walker, MA

  • Deputy Head of Inspectorate, Inspection, Enforcement & Standards Division
  • Medicines and Healthcare products Regulatory Agency (MHRA), 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

MHRA Update

Gail Francis

  • Expert Inspector, GCP
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Barbara D Wright

FDA Update

Barbara D Wright

  • Supervisory Investigator, Foreign Inspection Cadre, Office of Bioresearch Monito
  • FDA, United States
Lisbeth  Bregnhoj, PhD, MPharm

Danish Medicines Agency Update

Lisbeth Bregnhoj, PhD, MPharm

  • Medicines Inspector, GCP
  • Danish Medicines Agency, Denmark