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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 Roman
Head Regulatory Policy LaCan, 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)
Hugo Hamel, MBA, MSC
Associate Director, BRDD, Health Canada, Canada
Stephan Roenninger, DRSC
Director, Quality Compliance External Affairs , Amgen (Europe) GmbH, Switzerland
Raphael Sanches Pereira
General Manager of the Office for Medicines, ANVISA, Brazil
Heriberto Enrique García Escorza, MPA, RPH
Director, Instituto de Salud Pública de Chile, Chile
Juan Jose Villegas Campos
GMP Inspector, Laboratory Team of the Inspection and Certification Directorate, DIGEMID, Peru
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