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Mar 14, 2022 10:00 AM - Mar 16, 2022 3:15 PM

(US Eastern Standard Time)

Latin America Regulatory Conference

DIA Your Way! Join us virtually from the comfort of your home/office March 14-16 or watch later at a time that works for you. This event provides access to the materials for a full two months!

Welcome to Day Two and Session 4: Risk-based Approach in Regulatory Activities

Session Chair(s)

Cammilla  Horta Gomes, MA, MPharm

Cammilla Horta Gomes, MA, MPharm

LATAM Regulatory Policy Lead

Roche, Brazil

Maria Antonieta Tony Roman, MPharm

Maria Antonieta Tony Roman, MPharm

Head Regulatory Policy Emerging Markets LATAM

Novartis, Mexico

This session will open with a presentation on concepts and practices that guide risk-based regulatory activities. A subsequent panel discussion will bring the perspective of regulators and industry on the application of these concepts and practices in GMP inspections, quality control testing, and management of post-approval changes. This session will provide different perspectives and benefits about implementing this important tool, providing a set of information that will contribute to the identification of new opportunities to apply this approach.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Recognize the importance of a risk-based mindset and its potential benefits to regulatory activities
  • Identify best practices and examples of implementation of risk-based approaches
  • Outline opportunities for the expansion of these approaches in Latin America and the Caribbean


Hugo  Hamel, MBA, MSc

From Concept to Practice: Building a Risk-Based Mindset for Regulatory Activities

Hugo Hamel, MBA, MSc

Health Canada, Canada

Associate Director, BRDD

Stephan  Roenninger, DrSc


Stephan Roenninger, DrSc

Amgen (Europe) GmbH, Switzerland

Director, Quality External Affairs

Raphael  Sanches Pereira

Risk-based Approach in Regulatory Activities

Raphael Sanches Pereira

ANVISA, Brazil

Quality Assessment of Synthetic Medicines Office Manager

Heriberto Enrique García Escorza, MPA, RPh


Heriberto Enrique García Escorza, MPA, RPh

Instituto de Salud Pública de Chile, Chile


Juan Jose  Villegas Campos


Juan Jose Villegas Campos


GMP Inspector, Laboratory Team of the Inspection and Certification Directorate

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