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Session 11: Navigating Pharmacovigilance in Small Pharma: Strategies for Building Sustainable Frameworks
Session Chair(s)
Bethany Van Veen
CEO and Founder, Perspective Pharmacovigilance, United States
Small biotech and pharma companies have unique challenges in building a pharmacovigilance framework that requires the right expertise at the right time. Often small companies are facing budgetary and resourcing struggles and have to consider the risk of poor planning decisions that could impact product acquisition or commercialization in the future. This session will take a deep dive into the specific challenges small pharma companies face and provide practical solutions for managing these unique issues.
Learning Objective : - Define the specific challenges small pharma face with respect to building a pharmacovigilance framework
- Discuss how to design a plan to establish the PV function at a small pharma
- Recognize what is needed to demonstrate adequate oversight of PV vendors
Speaker(s)
James Cross, PHD, MS
Founder, Cross BioConsulting, United States
CJ Delgra, MD
PV Physician Medical Advisor, Perspective Pharmacovigilance, United States
Sylvia Dobo, MD
SVP, Global Drug Safety and Pharmacovigilance, Biocryst Pharmaceuticals, United States
Stephen Knowles, MD, MRCP
Vice President of Drug Safety Pharmacovigilance, Crinetics Pharmaceuticals, United States
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