Back to Agenda
Session 11: Navigating Pharmacovigilance in Small Pharma: Strategies for Building Sustainable Frameworks
Session Chair(s)
Bethany Van Veen
Pharmacovigilance Consultant
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)
Pharmacovigilance in a Startup Company – You’re in charge, now what?
James Cross, PhD, MS
Cross BioConsulting, United States
Founder
Speaker
CJ Delgra, MD
Perspective Pharmacovigilance, United States
PV Physician Medical Advisor
Navigating PV in Late-Stage Development in Small Biotech
Sylvia Dobo, MD
Biocryst Pharmaceuticals, United States
SVP, Global Drug Safety and Pharmacovigilance
Transitioning to Post-Approval in Small Biotech
Stephen Knowles, MD, MRCP
Crinetics Pharmaceuticals, United States
Vice President of Drug Safety Pharmacovigilance
Have an account?