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Session 8, Track A: Advancing Global Health through Regulatory Convergence and International Collaboration
Session Chair(s)
Carolina Sian, PharmD, RAC
Regulatory Affairs Director
CAEME, Argentina
Daniela Bravo, DrSc, MBA, MSc
Regulatory Policy and Intelligence Latam Associate Director
AbbVie, Brazil
This session will explore the importance and benefits of participating in international harmonization and convergence initiatives, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the International Medical Device Regulators Forum (IMDRF) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Attendees will hear firsthand from LATAM regulators about their experiences and impacts on their regulatory processes when participating in these initiatives and gain invaluable insights into how the regulators and industry can work for building capacity towards regulatory harmonization.
Learning Objective : - Understand the key benefits of ICH membership and engagement in this important platform for both regulators and industry
- Hear firsthand from LATAM regulators on their experiences in participating in international harmonization and convergence initiatives and the impact on their regulatory processes
- Recognize the importance of accelerating international convergence through IMDRF for medical devices and PIC/S for Regulatory Inspections
Speaker(s)
Advancing Global Health through Regulatory Convergence and International Collaboration
Geraldine Lissalde-Bonnet
International Council for Harmonisation (ICH), Switzerland
Secretary General
Regulatory Convergence: ANMAT's Experience in International Forums
Yesica Anastasio
ANMAT Ministry of Health, Argentina
Licenciada en Relaciones Públicas
Boosting Global Health through Regulatory Convergence and International Collaboration
William Oswaldo Cortez Mendoza
DIGEMID, Peru
Head of International Affairs, General Directorate of Medicines, Supplies, and D
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