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Session 1: PV Systems and Reporting to Health Authorities and Harmonization of Practices
Session Chair(s)
Raphael Elmadjian Pareschi, PharmD, MBA
Patient Safety Lead/ Head of Pharmacovigilance Brazil
Roche, Brazil
Louise Molloy
Pharmacovigilance & Medical Information Manager
IQVIA, Argentina
This session will review key aspects of pharmacovigilance systems from the National PV Centers and pharmaceutical industry standpoints. The session will provide examples of collaborative working tasks and stakeholders across multiple countries and discuss future challenges in terms of pharmacovigilance as privacy and data protection laws evolve worldwide.
Learning Objective : At the conclusion of this session, participants should be able to:- Discuss how Data Privacy Regulations impact pharmacovigilance systems and how to respond to the newer Data Privacy Laws across the region
- Analyze key topics of ICH guidelines and discuss how the harmonization builds a healthier pharmacovigilance system
- Describe the Pan American Network for Drug Regulatory Harmonization (PANDRH) in terms of harmonization of PV process across Americas
Speaker(s)
Speaker (Remote Presentation)
Rosa Maria Papale
ANMAT, Argentina
Head of Pharmacovigilance Department
Implementation of ICH Guidelines
Marcelo Vogler
ANVISA-GFARM, Brazil
Pharmacovigilance Manager
General Data Protection Regulation: The Domino Effect (Remote Presentation)
Christian Hebenstreit
Medidata Solutions, United Kingdom
General Manager and Senior Vice President EMEA
Regulations in Latin America
Pedro Seckler Yoshikawa, PharmD, MBA
Allergan, Brazil
Local Safety Officer
Regulations in Latin America
Karen Pizani
Abbott, Brazil
Regional Pharmacovigilance Manager
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