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Session 6 Track 1: The Crossroads Between Regulatory and Safety
Session Chair(s)
Brooke Casselberry, MS, RAC
Vice President, Advisory and Delivery
Epista Life Sciences, United States
Pharmacovigilance and Regulatory are two functional areas that are directly impacted by each other and that has become more evident by the COVID-19 pandemic. Regulatory decisions impact preparation for case load peaks and safety reporting, and safety reporting drives regulatory strategy for risk mitigation and submission optimization. Additionally, managing Pharmacovigilance systems with the increase demands on data intake has created a thoughtful approach to technology and process. Join this session to hear experiences and case study approaches to the lifecycle of data across regulatory to safety and coping with large data loads in the year 2020.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify key areas where unification between RIM and Pharmacovigilance can improve efficiency
- Recognize hidden risks that result from a non-unified RIM-PV systems and how to mitigate them
- Evaluate how systems can foster effective communication between teams
Speaker(s)
Seeking Synergy Between Regulatory and Safety
Mark Loudon
NNIT, United States
Advisory Director
Strategic PV Technology Challenges in the era of COVID-19
Bill Ringbloom, MBA
AstraZeneca, United States
IT Business Partner, Global Patient Safety
Integrated RIM and Pharmacovigilance: Meeting the Evolving Challenges of Life Cycle Management
Kristen Mandello, DVM
Zoetis, United States
Global PV, Signal Detection Manager
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