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Session 3: Real World Evidence
Session Chair(s)
Natalia Hristov, PharmD
Regional Pharmacovigilance Manager - a.i. Head of Americas
Merck S.A. , Brazil
Gislaine Villarta Capeleti Dib, PharmD
Pharmacovigilance Manager
PGA Farma, Brazil
This session will expose how data collected for the purpose of pharmacovigilance can also contribute with the decision-making when evidence is needed. Explore real-life examples from Latin American companies that have addressed regulatory or strategic needs through data generated from safety databases. This session will also consider the point of view from the regulatory agency when assessing the response to requirements by using data from safety databases.
Learning Objective : At the conclusion of this session, participants should be able to:
- Recognize from expert service providers how safety data can generate useful evidences
- State real examples of pharmacovigilance data being used for generating evidences in Brazil
- Describe the perspective from ANVISA when discussing the use of Real Word Data for regulatory purposes
Speaker(s)
The Use of Safety Database to Generate Real World Evidence
Guilherme Julian, MPharm, MSc
IQVIA, Brazil
Director, Real World Insights, Latin America
Case Study - Safety Data Generation Based on the Safety Database as Real World Data
Karen Sacomam Barbosa, RPh
Ache Laboratorios Farmaceuticos, Brazil
Pharmacovigilance Coordinator
Perspective From Regulator Concerning the Use of Safety Database to Generate Evidences
Gustavo Mendes Lima Santos, MPharm
Brazilian Health Regulatory Agency (ANVISA), Brazil
Herbal and Complementary Medicines Office - GMESP
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