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Virtual

Mar 06, 2023 10:00 AM - Mar 08, 2023 4:30 PM

(US Eastern Standard Time)

Latin America Annual Meeting

Latin America Annual Meeting is fully virtual. Join us from the comfort of your own space!

Session 6, Tracks A, B: The Journey of ICH Implementation in LATAM and Opportunities for Further Harmonization

Session Chair(s)

Leonardo  Semprun, PharmD

Leonardo Semprun, PharmD

Global Regulatory Policy Lead-LatAm

MSD, Panama

Lorena  Larrosa, RPh

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)

Jared  Auclair, PhD

The Journey of ICH Implementation in LATAM and Opportunities for Further Harmonization

Jared Auclair, PhD

Northeastern University, United States

Interim Dean and Professor

Mario  Alanis, PhD

ICH Guidelines Implementation Status by Authority Type

Mario Alanis, PhD

Erudee Foundation, Frpath, Mexico

Senior Advisor

Ana Carolina  Moreira Marino Araujo, PharmD

Status of ICH Implementation in Brazil - Reflection from ICH Member

Ana Carolina Moreira Marino Araujo, PharmD

ANVISA, Brazil

Head of the International Affairs Office

Miriam Jackeline Jackeline Loera Rosales

Implementation of ICH in Mexico

Miriam Jackeline Jackeline Loera Rosales

COFEPRIS, Mexico

Commissioner of Evidence and Risk Management

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