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  • Current Challenges in Vaccine Development

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Tuesday - Jul 02, 2013 10:00 AM
  • End Time:
  • Tuesday - Jul 02, 2013 11:00 AM
  • Location:
  • Online
  • This webinar on FDA vaccine regulations will cover the unique challenges to modern vaccine development. It will review the FDA regulations governing vaccine safety, potency and effectiveness. A case study approach will be used to discuss the implementation of Animal Rule.

    Why Should You Attend:

    The use of molecular techniques to identify and synthesize pathogen-associated immunogenic antigens, the globalization of vaccination efforts and the threat of bioterrorism have all drastically altered the vaccine landscape. The FDA has implemented regulations to streamline the approval process for vaccines and to provide timely access to at-risk populations. At the same time, the Agency has increased its vigilance on all stages of the vaccine development process, effectively partitioning it into safety and developmental activities.

    This webinar will provide the framework for understanding the modern vaccine approval process, providing a troubleshooting model for avoiding pitfalls and appropriately utilizing the FDA mechanisms for Accelerated, Fast Track and Priority Review procedures. The result will be faster development, and more timely delivery of the vaccine product, reducing the risk of recall. In addition, regulations stipulating the use of Animal Rule when studies in human subjects are not feasible or ethical, as in testing vaccines for smallpox, botulism, plague or anthrax, will be described. Clinical endpoints, immune response endpoints and conditions for the implementation of animal rule will be discussed through presentation of cases.

    Appropriate pharmaceutical examples, through use of case studies, will be described at each stage of the webinar. Involvement of and action on the part of the FDA and the industry will be discussed.

    Learning Objectives:

    By the completion of this program, participants will be able to

    - Describe the pathway for vaccine development and approval as regulated by the FDA
    - Review the safety, efficacy and consistency requirements for biologic vaccines
    - Explain the appropriate utilization of Accelerated Approval, Fast Track
    Approval and Priority Review for vaccine products
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