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Session 6, Tracks A, B: The Journey of ICH Implementation in LATAM and Opportunities for Further Harmonization
Session Chair(s)
Leonardo Semprun, PharmD
Global Regulatory Policy Lead-LatAm
MSD, Panama
Lorena Larrosa, RPh
Regulatory Affairs Manager
Abbvie, Uruguay
The purpose of this session is to discuss how international regulatory collaboration and convergence enables faster access to medicines internationally for patients. Session participants will be able to understand where the ICH Latin America (LATAM) members and observers are in terms of the adoption of ICH guidelines based on how our rapidly changing global regulatory environment calls for a proactive focus on capacity building, operational excellence, and continuous improvements.
Learning Objective : At the conclusion of this session, participants should be able to:
- Discuss trends on general collaboration and convergence in the region
- Describe the work of the ICH members in their continued journey towards harmonization
- Identify ICH implementation status by authority type
- Assess challenges and lessons learned about convergence initiatives in the region and opportunities in capacity building
Speaker(s)
The Journey of ICH Implementation in LATAM and Opportunities for Further Harmonization
Jared Auclair, PhD
Northeastern University, United States
Interim Dean and Professor
ICH Guidelines Implementation Status by Authority Type
Mario Alanis, PhD
Erudee Foundation, Frpath, Mexico
Senior Advisor
Status of ICH Implementation in Brazil - Reflection from ICH Member
Ana Carolina Moreira Marino Araujo, PharmD
ANVISA, Brazil
Head of the International Affairs Office
Implementation of ICH in Mexico
Miriam Jackeline Jackeline Loera Rosales
COFEPRIS, Mexico
Commissioner of Evidence and Risk Management
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