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Plenary 7: Biosimilar Products Development in Latin America: Challenges and Opportunities
Session Chair(s)
José Ascencion Hernández, PhD
Pharmacology, Basic Medical Sciences
Instituto Tecnologico De Estudios Superiores De Monterrey, Mexico
Biosimilar products are emerging as an option of treatment. LA pharmaceutical companies are trying to introduce their products to the global market, however the clinical research process has not been clearly defi ned to guarantee safety. This session will provide an overview of experiences of regulatory guidelines in clinical evaluation of biosimilar products and how troubles have been solved. The aim of this session is to present and contrast the global experiences in clinical evaluation of biosimilar products and how LA clinical research can support pharmaceutical companies to evaluate their biosimilar products.
Speaker(s)
Areli Ceron Sanchez, MSc
National Commission On Bioethics, Mexico
Director of Operations
Development & Regulation of Biosimilars: Brazilian Experience
Laura Gomes Castanheira
Hemobrás- Empresa Brasileira de Hemoderivados e Biotecnologia, Brazil
Head of Regulatory Affairs
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