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SINDUSFARMA

Nov 13, 2019 8:00 AM - Nov 13, 2019 5:30 PM

Rua Alvorada, 1280 - Vila Olimpia, Sao Paulo - SP, 04550-044, Brazil

Latin America Pharmacovigilance and Risk Management Strategies Workshop

The premier meeting to discuss the current safety, pharmacovigilance, and risk management strategies landscape in LATAM.

Overview

DIA's Latin America Pharmacovigilance and Risk Management Strategies Workshop is the leading resource to discuss the current safety, pharmacovigilance, and risk management strategies landscape in LATAM. Attendees will gain insight from biopharmaceutical industry experts and global regulatory agencies on current policies and guidances. The conference is aimed to stimulate discussion, foster collaboration, and enhance standardization of regulations to meet global compliance.

*The primary language is English, however both English and Portuguese will be spoken during the Workshop. Simultaneous Translation will be available

Featured topics

  • Innovation and its impact on the future role of the PV professional
  • Practical implementation of risk minimization initiatives
  • Relevance of social media in safety data collection
  • Developments in PV automation and AI in the fields of case identification, intake, and processing
  • The role of RWE in safety monitoring

Who should attend?

Professionals involved in:

  • Drug Safety/Pharmacovigilance
  • Risk Management, including Risk Evaluation and Mitigation Strategies (REMS)
  • Benefit-risk assessment and Communication
  • Regulatory Affairs
  • Medical Product Safety Assessment
  • Clinical Research
  • Pharmacoepidemiology
  • Post-market studies and Real World Evidence Generation
  • Customer Engagement Programs, including Patient Support Programs
  • Medical Information
  • Medical Communications
  • Health Outcomes

Learning objectives

At the conclusion of this activity, participants should be able to:
  • Compare how international Data Privacy Regulations impact pharmacovigilance systems at a global and regional level
  • Assess the basic RWE study design considerations and describe the role of real-world data in active safety monitoring and its strengths and limitations
  • Analyze the importance of planning pharmacovigilance activities and risk minimization measures
  • Discuss recent key developments in PV automation and AI in the fields of case identification, intake, and processing

Program Committee

  • Gislaine Villarta Capeleti Dib, PharmD
    Gislaine Villarta Capeleti Dib, PharmD Pharmacovigilance Manager
    PGA Farma, Brazil
  • Natalia  Hristov, PharmD
    Natalia Hristov, PharmD Regional Pharmacovigilance Manager - a.i. Head of Americas
    Merck S.A. , Brazil
  • Michele  Lawall Dornelas
    Michele Lawall Dornelas Pharmacovigilance Manager
    AbbVie, Brazil
  • Rosana M. Mastellaro, PharmD, RPh
    Rosana M. Mastellaro, PharmD, RPh Director, Technical Regulatory Affairs and Innovation
    Sindusfarma, Brazil
  • Deirdre  McCarthy, MSc
    Deirdre McCarthy, MSc Senior Director, Pharmacovigilance and Safety Operations
    Allovir, United States
  • Louise  Molloy
    Louise Molloy Pharmacovigilance & Medical Information Manager
    IQVIA, Argentina
  • Raphael Elmadjian Pareschi, PharmD, MBA
    Raphael Elmadjian Pareschi, PharmD, MBA Patient Safety Lead/ Head of Pharmacovigilance Brazil
    Roche, Brazil
  • Bianca  Passos, MBA, RPh
    Bianca Passos, MBA, RPh Country Safety Head - Brazil
    Sanofi, Brazil

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