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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)
Ivone Takenaka
Associate Director, GRSB-CMC and LATCAN Reg Expert, Bristol-Myers Squibb Company, United States
Latin America - Post Approval Changes and the Industry Perspective
Raphael Sanches Pereira
General Manager of the Office for Medicines, ANVISA, Brazil
Post Approval Changes in Brazil: Current Scenario and Perspectives
Marcio Andre Silva
Regulatory Governance / P&I Manager, Emerging Markets & Asia Pacific - Brazil, GlaxoSmithKline Brazil Ltda, Brazil, Brazil
Post Approval Change Requirements and Discussion of New Quality Consultation Guidance