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Hilton Baltimore Inner Harbor

27 ene 2025 7:30 a.m. - 29 ene 2025 12:45 p.m.

401 W Pratt Street, Baltimore, MD 21201, USA

Global Pharmacovigilance and Risk Management Strategies Conference

Stay current with the latest safety regulations from global health authorities and regulatory experts!

Early Bird Rates End

DAYS

HOURS

MINUTES

SECONDS

Session 11: Operations: Small vs. Big Pharma

Session Chair(s)

Bethany  Van Veen

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
  • Design a plan to establish the PV function at a small pharma
  • Understand what is needed to demonstrate adequate oversight of PV vendors

Speaker(s)

Representative Invited

Pharmacovigilance in a Startup Company – You’re in charge, now what?

Representative Invited

Cross BioConsulting, United States

Sylvia  Dobo, MD

Speaker

Sylvia Dobo, MD

Biocryst Pharmaceuticals, United States

SVP, Global Drug Safety and Pharmacovigilance

Stephen   Knowles

Speaker

Stephen Knowles

Crinetics Pharmaceuticals, United States

Vice President of Drug Safety Pharmacovigilance

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