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Session 4: Assessing the Impact of COVID and Implications for Pharmacovigilance in the Future
Session Chair(s)
Sarah Vaughan
Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
During 2020, the COVID-19 pandemic has created numerous challenges and opportunities across the healthcare landscape. Regulatory authorities have provided emerging guidance during the pandemic that has the potential to impact ongoing regulatory expectations. This session will begin with a review of the key challenges experienced and the initial industry response, followed by a regulatory overview of current COVID-related data collection requirements and its impact on post-marketing surveillance. This session will also explore several operational strategies that have proved successful and warrant long-term consideration. Lastly, participants will be invited to engage in a dialogue on the future implications for pharmacovigilance.
Learning Objective : - Identify the key challenges faced by pharmacovigilance departments while operating during the COVID pandemic
- Describe the relevant regulatory requirements related to COVID data collection and understand their wider impact
- Detail the operational impacts across the three vital pillars (people, process and technology) of every pharmacovigilance organization and highlight opportunities for future efficiencies
Speaker(s)
Vita M. Petrik, BSN
Senior Director, PV Processes, Partnerships and Contracts , Astrazeneca Pharmaceuticals, United States
AstraZeneca Vaccine Plan An Extraordinary Opportunity
Kendal Harrison
Pandemic Systems Delivery Manager, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
A Regulatory Perspective on COVID Data Collection & Its Impact on Post Marketing-surveillance
Annette S. Williams, MBA, RPH
Vice President, Pharmacovigilance, IQVIA, United States
The Operational Realities and Benefits of the COVID Era
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