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Virtual

Mar 06, 2023 10:00 AM - Mar 08, 2023 4:30 PM

(US Eastern Standard Time)

Latin America Annual Meeting

Latin America Annual Meeting is fully virtual. Join us from the comfort of your own space!

Session 2, Tracks C: Strengthening Pharmacovigilance in LATAM and Opportunities for Synergies

Session Chair(s)

Gislaine Villarta Capeleti Dib, PharmD

Gislaine Villarta Capeleti Dib, PharmD

Patient Safety Manager

PGA Farma, Brazil

Josue  Bautista, PharmD

Josue Bautista, PharmD

GCP/PV Auditor

Novartis, Mexico

Rosana M. Mastellaro, PharmD, RPh

Rosana M. Mastellaro, PharmD, RPh

Director, Technical Regulatory Affairs and Innovation

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)

Michelle  Grimes, MSc

Update of ICH e2D Revision: industry and Health Authority Perspective

Michelle Grimes, MSc

MSD, United Kingdom

Head, International Pharmacovigilance. GCS&PV

Julia  Souza Vidal, MPH

Opportunities in pharmacovigilance - Brazil

Julia Souza Vidal, MPH

ANVISA, Brazil

Pharmacovigilance Manager

Salvador  Alvarado Lopez, MD, MPH, MSc

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

Flávia  Moreira Cruz, PharmD

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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