Regional Regulations for Biotherapeutics

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Thursday, September 11, 2014 | 9:15 - 10:25 | Gávea B

Speakers will present a global market access and policy landscape analysis of biologics, biosimilars and non-comparable products with attention given to regulatory frameworks in Brazil, Mexico, Colombia and Argentina. Perspectives on nonclinical safety assessments of biologics will also be presented. To improve human health, there is a need to provide timely access to biotherapies treating chronic and grievous illnesses. The general principles and specific technical topics, including species selection, study duration, PKPD support and carcinogenicity of non-clinical safety assessments of biologics will be discussed. These are prerequisites to ensure patients receive a safe and effective drug, based on the best science and a risk/benefit evaluation. Studies must be designed and conducted to inform safe dosing and patient monitoring, using animals ethically and responsibly.

Speakers

  • Reginaldo Arcuri, President, Grupo FarmaBrasil, Brazil
  • Lic. Mikel Arriola, Commissioner, Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), Mexico*
  • Dr. Dirceu Barbano, Director-Chairman, Brazilian Health Surveillance Agency (ANVISA), Brazil*
  • Prof. Andreas Baumann, Director and Principal Scientific Expert for Biologics within Global Early Development, Bayer Pharma AG
  • Joseph Damond, Senior Vice President, International Affairs, BIO (moderator)
  • Marité Prieto Faria, Regulatory Affairs, Safety and Compliance Director, Amgen, Brazil 

*Invited