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Session 2, Tracks C: Strengthening Pharmacovigilance in LATAM and Opportunities for Synergies
Session Chair(s)
Gislaine Villarta Capeleti Dib, PharmD
Pharmacovigilance Manager
PGA Farma, Brazil
Josue Bautista, PharmD
GCP/PV Auditor
Novartis, Mexico
Rosana M. Mastellaro, PharmD, RPh
Director, Technical Regulatory Affairs and Inovation
Sindusfarma, Brazil
This session will evaluate the importance of strengthening Pharmacovigilance (PV) systems. The experiences of different Healthy Authorities (HAs) and other entities will be shared, focused on synergies, good practices, and harmonization achievements implemented in the PV area, including strategies for effective communication with society. Attendees will analyze opportunities to improve their own process, by following good regulatory practices. In addition, attendees will gain insights on effective communication strategies with society and the possibilities of synergy for communication between the regulated sector and HA.
Learning Objective : - Describe the best practices and convergent strategies between HA
- Analyze the update of recent evaluations of publications from different entities and HA
- Analyze opportunities for interaction with HAs and possibilities for joint communication strategies centered around the patient
- Create processes aligned with the priorities established by regulatory PV systems
Speaker(s)
Update of ICH e2D Revision: industry and Health Authority Perspective
Michelle Grimes, MSc
MSD, United Kingdom
Head, International Pharmacovigilance. GCS&PV
Opportunities in pharmacovigilance - Brazil
Julia Souza Vidal, MPH
ANVISA, Brazil
Pharmacovigilance Manager
E2B Implementation and WHODrug Global as Medicinal Products Coding Standard in LATAM
Salvador Alvarado Lopez, MD, MPH, MSc
Uppsala Monitoring Centre, Sweden
Regional Pharmacovigilance Manager
Update of ICH E2D Revision: Industry and Health Authority Perspective
Flávia Moreira Cruz, PharmD
ANVISA, Brazil
Specialist at Pharmacovigilance Officer (GFARM)
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