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Hyatt Regency Bethesda

Apr 13, 2015 7:00 AM - Apr 15, 2015 12:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

CMC Workshop 2015

Session 02C: Case Studies and Post Approval Change Requirements in Latin America

Session Chair(s)

Rebecca E. Thomas, MS

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

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

Raphael  Sanches Pereira

Post Approval Changes in Brazil: Current Scenario and Perspectives

Raphael Sanches Pereira

ANVISA, Brazil

Quality Assessment of Synthetic Medicines Office Manager

Marcio Andre Silva

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

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