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Miami Marriott Biscayne Bay

May 14, 2014 9:00 AM - May 15, 2014 6:15 PM

1633 North Bayshore Drive, Miami, FL 33132

6th Latin American Regulatory Conference (LARC) 2014

Session 4: Panel Discussion: Multi-regional Clinical Trials (MRCTs)

Session Chair(s)

Justina  Molzon, JD, MS

Justina Molzon, JD, MS

Consumer Services

Consumer Services, United States

This session is devoted to discuss specifics on the value and potential benefits of MRCTs. Participants from regulatory agencies, the pharmaceutical industry, and academia will come together to identify issues and make recommendations for resolving major challenges with the aim of improving the capacity of the Latin American region to carry out MRCTs.

Speaker(s)

Justina  Molzon, JD, MS

Introduction

Justina Molzon, JD, MS

Consumer Services, United States

Consumer Services

Cesar  Masache, MD

Ecuadorian Perspective

Cesar Masache, MD

Ministry of Public Health, Ecuador

Head, National System on Pharmacotherapy & Pharmacovigilance

Stephen  Sonstein, PhD

From Compliance to Compentency: Core Compentencies for the Clinical for the Clinical Research Professional

Stephen Sonstein, PhD

MRTC Center of Brigham and Women's Hospital and Harvard, United States

Chair, CAAHEP; Senior Advisor

Vitor  Harada, MBA, RPh

Interactive Discussions with Panelists and Audience

Vitor Harada, MBA, RPh

Quintiles, Brazil

Senior Director, Clinical Site Monitoring

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