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Session 2: How to Communicate Signals and Risks Appropriately with the Patient in Mind?
Session Chair(s)
Gislaine Villarta Capeleti Dib, PharmD
Pharmacovigilance Manager
PGA Farma, 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 whole product lifecycle. Exploring existing and developing strategies to plan and optimize risk management activities for known and potential risks of approved product and properly quantify and characterize them over time are crucial for the success of a risk management cycle. This session will provide an overview on the importance of an effective strategy for risk communication to enable the general public and healthcare professionals to make informed decisions and protect themselves and their patients.
Learning Objective : At the conclusion of this session, participants should be able to:
- Analyze if the communication of signals and risks are being conducted appropriately and with the patient in mind
- List strategies adopted by pharmaceutical companies to measure and increase the reach of additional risk minimization activities
- Discuss strategies to better assess the effectiveness of proposed measures
Speaker(s)
Speaker
Josue Bautista, PharmD
Novartis, Mexico
GCP/PV Auditor
Speaker
Walter Straus, DrMed, MD, MPH, FACP
Moderna, United States
Vice President, Safety and PV
Speaker
Manuela Grizoto, PharmD
Sanofi, Brazil
Pharmacovigilance Manager
Speaker
Patricia Fonseca Agostini
Novartis, Brazil
RMP Manager and Manager Group
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