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Thursday, July 1 • 11:30am - 12:30pm
#425 SL: Regulator Perspective: Maintaining GCP During Covid-19 and Beyond the Pandemic

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Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-652-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Paula Walker, MA

Speaker

MHRA Update
Gail Francis

FDA Update
Barbara D Wright

Danish Medicines Agency Update
Lisbeth Bregnhoj, PhD, MPharm



Speakers
avatar for Paula Walker

Paula Walker

Deputy Head of Inspectorate, Inspection, Enforcement & Standards Division, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Paula Walker has been with the MHRA since 2009, joining as a GCP inspector, and subsequently moving to the role of Operations Manager for the GCP team in 2013. Paula is currently the Deputy Group Manager for the MHRA Inspectorate, and has been the Inspectorate Unit Manager since November... Read More →
avatar for Lisbeth Bregnhoj

Lisbeth Bregnhoj

Medicines Inspector, GCP, Danish Medicines Agency, Denmark
Lisbeth is a GCP inspector at the Danish Health and Medicines Agency. She also has experience as a clinical trial assessor, experience from a research and hospital perspective (Clinical pharmacology at a University Hospital) and from the medicinal industry as a GCP auditor. Lisbeth... Read More →
avatar for Gail Francis

Gail Francis

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

Barbara Wright

Supervisory Investigator, Foreign Inspection Cadre, Office of Bioresearch Monito, FDA, United States
Barbara Wright currently serves as the Supervisor of the Foreign Inspection Cadre within FDA’s Office of Bioresearch Monitoring Operations. She is responsible for the assignment and oversight of international inspections covering BA/BE, GCP, GLP, and PV compliance programs. Barbara... Read More →


Thursday July 1, 2021 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  08: RD Quality-Compliance, Forum