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Session 3: Risk Management
Session Chair(s)
Michele Lawall Dornelas
Pharmacovigilance Manager
AbbVie, Brazil
Bianca Passos, MBA, RPH
Country Safety Head - Brazil
Sanofi, Brazil
Risk Management aims to ensure that the benefit-risk profile of a medicinal product is managed optimally during the product lifecycle, knowledge gaps at the time of authorization are elucidated, and risks are further quantified and characterized over time. Risk Management, including periodic signal detection and risk minimization, is receiving more and more attention from regulators and industry. This session will provide an overview on what is expected regarding this matter and best-practices performed by other players, such as Health Authorities.
Learning Objective : At the conclusion of this session, participants should be able to:- Analyze the importance of planning pharmacovigilance activities and risk minimization measures
- Develop and implement RMPs and RMM
- Discuss how to perform signal detection and identify relevant risks that should be described for each drug
- Assess the effectiveness of proposed measures
Speaker(s)
Industry Perspective on Signal Detection and Risk Management: From the Theory to Decision Making - Practical Examples from the Perspective of Local Surveillance
Pedro Lima, DrMed, MSC
Sanofi, Brazil
Regions Medical Safety Head
Industry Perspective on Signal Detection and Risk Management: From the Theory to Decision Making - Practical Examples from the Perspective of Global Surveillance
Maria Lucia Buziqui Piruzeli, MD
Eli Lilly & Company, Brazil
Medical Advisor – Global Patient Safety
Industry Perspective on Signal Detection and Risk Management: From the Theory to Decision Making - Practical Examples from the Perspective of Global Surveillance
Luis Henrique de Souza Teodoro, MSC
Eli Lilly & Company, Brazil
Clinical Surveillance Scientist
Health Literacy and Practical Implementation: How the Risk Management Plans Defined by the MAH and Industries are Translated into the HCP Routine
Helaine Capucho, DRSC
University of Brasilia , Brazil
Professor