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Welcome to Day Two and Session 4: Risk-based Approach in Regulatory Activities
Session Chair(s)
Cammilla Horta Gomes, MA, MPharm
LATAM Regulatory Policy Lead
Roche, Brazil
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
Speaker(s)
From Concept to Practice: Building a Risk-Based Mindset for Regulatory Activities
Hugo Hamel, MBA, MSc
Health Canada, Canada
Associate Director, BRDD
Panelist
Stephan Roenninger, DrSc
Amgen (Europe) GmbH, Switzerland
Director, Quality External Affairs
Risk-based Approach in Regulatory Activities
Raphael Sanches Pereira
ANVISA, Brazil
Quality Assessment of Synthetic Medicines Office Manager
Panelist
Heriberto Enrique García Escorza, MPA, RPh
Instituto de Salud Pública de Chile, Chile
Director
Panelists
Juan Jose Villegas Campos
DIGEMID, Peru
GMP Inspector, Laboratory Team of the Inspection and Certification Directorate
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