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Session 2C: Clinical Trials and Marketing Applications in Latin America CMC Considerations
Session Chair(s)
Rebecca E. Thomas, MS
Owner
Bekki Thomas Consulting, LLC, United States
ANVISA regulators will discuss the CMC and Clinical Trials requirements in the Latin America region. Industry speakers will share opportunities, challenges and recent experience with clinical trial and marketing applications. This will include experience with recent guidance such as the API Stability Guidance Resolution 45 issued August 2012. This will be followed by a panel discussion including additional industry experts. An opportunity for the audience to master the intricacies of CMC aspects of clinical trial and marketing applications in the Latin America market with special focus on Brazil.
Speaker(s)
CMC Requirements in Brazil- Regulatory Aspects
Ana Carolina Moreira Marino Araujo, PharmD
ANVISA, Brazil
General Manager, Office of Inspections and Law Enforcement
Clinical Trial Requirements in Brazil - CMC Considerations
Fanny N. Viana, PharmD
Brazilian Health Surveillance Agency-Anvisa, Brazil
Sanitary Surveillance and Regulation Specialist - Pharmacist, COPEM, GESEF
Industry Experience with Clinical Trial and Marketing Applications in Latin America
Rebecca E. Thomas, MS
Bekki Thomas Consulting, LLC, United States
Owner
Panel Industry Representative
Ganapathy Mohan, PhD
Merck & Co., Inc., United States
Head of External Affairs (Quality)
Panel Industry Representative
Marcio Andre Silva
GlaxoSmithKline Brazil Ltda, Brazil, Brazil
Regulatory Governance / P&I Manager, Emerging Markets & Asia Pacific - Brazil
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