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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 3: Integrity of the Supply Chain and Global Product Quality

Session Chair(s)

Mike  Ward

Mike Ward

Coordinator, Regulatory Systems Strengthening, EMP

World Health Organization (WHO), Switzerland

Latin American markets have become more vulnerable to and negatively impacted by the international movement of spurious, substandard, falsified, falsely-labeled and counterfeit (SSFFC) medical products. This session will focus on the region’s efforts and initiatives to ensure that the trade in legitimate products is not disrupted. Specific areas to be discussed, include, but are not limited to, a) good distribution practices, b) controls on components used as part of good manufacturing practices and quality management systems, c) import and export practices, d) dispensing practices via the Internet, e) detection technologies, among others.

Speaker(s)

Mike  Ward

Introduction

Mike Ward

World Health Organization (WHO), Switzerland

Coordinator, Regulatory Systems Strengthening, EMP

Jésica  Carino

Traceability in Brazil

Jésica Carino

Medicamentos y Productos Médicos, ANMAT, Argentina

Fiscalizadora, Programa Nacional de Control de Mercado de

Raul  Mendoza Paredes

Guatemalan Regulation on Counterfeit Medicines

Raul Mendoza Paredes

Ministry of Public Health and Social Assistance, Guatemala

Coordinator, Legal & Technical Unit

Anthony  Zook, PharmD

Update on RX360

Anthony Zook, PharmD

Merck and Co., Inc., United States

Senior Project Manager, Counterfeits Management

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