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Fundamentals of Regulatory Affairs – North America Workshop

February 9 @ 8:00 am - 5:00 pm

Fundamentals of Regulatory Affairs – North America Workshop

A one-day comprehensive & Interactive course

  • Overview of the Regulatory Approval Process
  • Regulatory Approval Pathways (US & Canada)
  • Chemistry, Manufacturing, and Controls requirements through stages of development
  • Nonclinical study requirements and timing within development
  • Meetings with the regulatory agency
  • Investigational application filing and requirements
  • Clinical study phases
  • Safety reporting and adverse events
  • Informed consent & ethics committee requirements
  • Documentation requirements
  • Marketing application preparation & submission

Activities:

  • Regulatory approval pathway strategy
  • Regulatory agency meeting strategy & preparation
  • Clinical study design strategy
  • Marketing application strategies

Who Should Attend

This course is directed towards individuals in the Pharmaceutical, Biopharmaceutical, and allied industries with daily responsibilities in the following areas:

  • Quality Assurance
  • Regulatory Affairs
  • Drug Development
  • Product Registration
  • Product Development
  • Clinical Research
  • Compliance
  • Documentation and Technical Writing
  • Submissions
  • Project Management
  • Electronic Submissions
  • Training
  • Academia

Certificate of Attendance and Course Material

  • All participants will receive a certificate of attendance upon completion of the course.
  • The participants will be receiving specially prepared course manual.

Details

Date:
February 9
Time:
8:00 am - 5:00 pm