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DIA Conference to Provide FDA, EMEA, Health Canada, Emerging Regions, NGO, and Industry Perspectives on Global Vaccine Development
Date:9/29/2009

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  • Regulatory Approaches and Pathways for Global Vaccine Development: FDA, EMEA, Emerging Regions and Industry Perspectives
  • Prequalification of Global Vaccines
  • Special Presentation on Ethical Considerations in Global Vaccine Development
  • Novel Approaches to Global Vaccine Development
  • Global Vaccine Development: Path Forward and Open Dialogue
  • Speakers will include:
  • Norman Baylor, PhD, Director, Office of Vaccines Research & Review (OVRR), CBER, FDA
  • David Wood, PhD, Coordinator of the Quality, Safety & Standards Team of the Department of Immunization, Vaccines & Biologicals, WHO
  • Vincent Ahonkhai, MD: Senior Regulatory Officer, Global Health Delivery, Bill and Melinda Gates Foundation
  • Christine Grady, MSN, PhD, Head Section on Human Subjects Research, Department of Bioethics, National Institutes of Health Clinical Center
  • Jesse Goodman, MD, MPH, Acting Chief Scientist & Deputy Commissioner for Scientific & Medical Programs for FDA, will deliver the keynote address.

    "In September 2008 the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA) published an important FDA Guidance Document that will expand the FDA's role in facilitating the development of new vaccines for global bacterial, viral, and parasitic diseases affecting millions of people in developing countries worldwide," explains Program Co-chair Michael Brennan, PhD, Senior Advisor for Global Affairs, Aeras Global TB Vaccine Foundation. "This symposium will explore this new guidance in depth and discuss the necessary paths to develop vaccines for global diseases."

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