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Biosimilar Products Training

Nov 22 2013 8:00AM - Nov 23 2013 5:00PM | MEDICA SUR Auditorio del Centro de Investigación Farmacológica y Biotec Puente de Piedra 150. Col. Toriello Guerra Mexico City 14050 Mexico

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Overview 

Early-bird offer extended to October 21st!


Training in Biologic Medicinal Products and Biosimilars Drug Information Association (DIA) - Médica Sur

Course will be taught in Spanish

Who Should Attend 

Professionals involved in:

  • Clinical research and development
  • Quality assurance
  • Regulatory affairs
  • CRO’s
  • Data management
  • SOP administration
  • Clinical site operations
  • Pharmacists
  • Health care professionals: Administrators and Managers, Institutional formularies Decision-makers

Learning Objectives 

  • Acknowledge the patent cliff of biologics and the rise of the biosimilars market
  • Identify the divergence between generics and biosimilars from a scientific and regulatory perspective
  • Differentiate the regulatory process for biologics and biosimilars among the ICH region and identify main regulatory processes in Latin America
  • Understand the scientific and technical requirements for biologic development and the complexity of biotechnology products and their mode of production
  • Portray the requirements for biosimilarity demonstration
  • Recognize possibilities of interchangeability
  • Describe the selection of clinical models, design endpoints, and methods of clinical trials with biologics
  • Comprehend the immunogenicity-related safety problems with biologics
  • Identify safety factors for biologics and biosimilars’ approval application and their marketing authorizations
  • Evaluate and sketch main safety specifications, pharmacovigilance issues and biosimilar products risk management

Contact Information 

For more information about this training course, please contact:

Washington, DC
Mr. Alejandro Bermudez-Del-Villar, MA/IBBD
Latin American and Global Development Coordinator
Alejandro.Bermudez@diahome.org

Mexico
Ms. Angelica Martinez
CIF-BIOTEC, Medica Sur
Tel. +52 55-5424-7200 Ext. 7281
AMartinezr@medicasur.org.mx

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