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Session 3, Track B: Challenges, Practices, and Governance in Pharmacovigilance and Technovigilance: Harmonization Efforts in Safety
Session Chair(s)
Rosana M. Mastellaro, PharmD, RPh
Director, Technical Regulatory Affairs and Innovation
Sindusfarma, Brazil
Josue Bautista, PharmD
GCP/PV Auditor
Novartis, Mexico
The session will cover various important topics related to pharmacovigilance (PV) and technovigilance. It will provide an overview of the current legislations in place for these fields, highlighting the roles of both ICH and non-ICH members. Participants will also be informed about the ongoing PV harmonization projects aimed at enhancing global safety monitoring systems. The session will include discussions on the influential role of UMC (Uppsala Monitoring Centre) and its active participation in the field. Furthermore, the session will shed light on the electronic transmission of safety information, ensuring efficient and timely exchange of data. The IMDRF framework and regional initiatives will be explored in the context of improving pharmacovigilance and technovigilance practices. Lastly, the session will emphasize the importance of reliance in pharmacovigilance and technovigilance, promoting trust and collaboration among stakeholders to ensure the safety of medicines and medical devices.
Learning Objective : - Know and understand the Pharmacovigilance and Technovigilance landscape in Latin America
- Understand the level of implementation of ICH and IMDRF principles in Latin America, including the harmonization status across the region for expedited reporting, aggregate reporting, and risk management
- To understand actions needed for reliance in the safety monitoring of medicines and medical devices
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