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
Horsham, PA (Vocus) September 30, 2009
The Drug Information Association (DIA) will present FDA, EMEA, Health Canada, emerging region, NGO, and industry perspectives on Global Vaccine Development at the Global Vaccine Development for World Health Symposium from November 3-4 in Bethesda, MD. This two-day symposium will address the regulatory pathways for the development of global vaccines to treat infectious diseases such as tuberculosis, malaria and H1N1.
Representatives and regulatory experts from the US Food and Drug Administration (FDA), World Health Organization (WHO), Bill & Melinda Gates Foundation, International Vaccine Initiative (IVI), Developing Countries Regulatory Network (DCRN), and BIO Ventures for Global Health (BVGH) will discuss strategies for the development and regulation of preventative vaccines for global diseases. Special emphasis will be given to the WHO prequalification process and FDAAA voucher program relative to global vaccine development for world health. Session topics will include:
- 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."
Click here to register.
About the Drug Information Association (DIA)
DIA serves more than 30,000 professionals involved in the biopharmaceutical industry and regulatory affairs worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China, the Association is led by its volunteer-based Board of Directors and executive management team. For more information, visit http://www.diahome.org or call 215-442-6100.
Contact: Joe Krasowski