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.
