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Session 02C: Case Studies and Post Approval Change Requirements in Latin America
Session Chair(s)
Rebecca E. Thomas, MS
Owner
Bekki Thomas Consulting, LLC, United States
Multi-national companies are challenged with the rapidly evolving regulatory environment in Latin America. The region has diverse country specific requirements that impact NCE’s and life cycle management of the assets. An industry speaker will present an overview of post approval changes and the impact on industry followed by an update on challenges with international harmonization and RDC 58 discussion presented by the Office of Evaluation of Post Approval Changes of the Brazilian Health and Surveillance Agency. Example case studies of simple post approval changes and the impact to industry will be presented. The session will include an opportunity for CMC experts to ask questions and discuss opportunities for convergence or regionalization of the regulatory requirements.
Speaker(s)
Latin America - Post Approval Changes and the Industry Perspective
Ivone Takenaka
Bristol-Myers Squibb Company, United States
Associate Director, GRSB-CMC and LATCAN Reg Expert
Post Approval Changes in Brazil: Current Scenario and Perspectives
Raphael Sanches Pereira
ANVISA, Brazil
General Manager of the Office for Medicines
Post Approval Change Requirements and Discussion of New Quality Consultation Guidance
Marcio Andre Silva
GlaxoSmithKline Brazil Ltda, Brazil, Brazil
Regulatory Governance / P&I Manager, Emerging Markets & Asia Pacific - Brazil