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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, Merck Sharp & Dohme LLC , United States
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
Interim Dean and Professor, Northeastern University, United States
ICH Guidelines Implementation Status by Authority Type
Senior Advisor , Erudee Foundation, Frpath, Mexico
Status of ICH Implementation in Brazil - Reflection from ICH Member
Head, International Affairs Office, ANVISA, Brazil
Implementation of ICH in Mexico
Commissioner of Evidence and Risk Management, COFEPRIS, Mexico
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