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  • Regulatory Requirements for IND to NDA, BLA and 505(b)(2)

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - May 02, 2013 10:00 AM
  • End Time:
  • Thursday - May 02, 2013 11:00 AM
  • Location:
  • Online
  • This training on guidelines for pharmaceutical product applications will cover regulatory requirements for the IND, its content and format, and CMC requirements for biopharmaceuticals from IND to BLA. It will also discuss combination product development via 505(b)(2) applications.

    Why Should You Attend:

    This session will help you understand how Early Stage Drug Development necessarily involves both a Business and a Regulatory Strategy with the need for the process being cost effective, streamlined and efficient.

    The training will empasize the importance of developing a Business Plan in the context of Drug Product Development and positioning- beginning with a Pre-IND Meeting to an IND (Investigational New Drug Application) Filing and a seamless transition to late stage Development and Commercialization via an NDA (New Drug Application) or BLA (Biologics Licensing Application) Filing and the essential differences between the two. Additionally Combination Product Development via 505(b)(2) Applications will also be considered along with Risk Analysis Profiles and the usefulness of a Design History File.

    Areas Covered in the Webinar:

    This webinar will provide an overview of the following topics:

    1. Regulatory Requirements for the IND
    2. Strategic Planning
    3. Efficient Implementation and Communication with the FDA
    4. Investigational New Drug (IND) Filing Requirements (Guidelines)
    5. Content and Format of IND's
    6. Plan for FDA-Sponsor Meetings
    7. FDA Expectations and CMC Data
    8. Chemistry, Manufacturing and Controls (CMC)
    9. Requirements for Biopharmaceuticals (from IND to BLA)
    10. Critical CMC Data Required at all Stages
    Development History Reports and Current Expectations
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