Orphan Drug Application and Submission
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This course is available as a client site course. Please click here for more information.
Who Should Attend
This course is intended for professionals within the
pharmaceutical and biopharmaceutical industries. It will be
especially beneficial for:
• Document Managers
• Regulatory Affairs Personnel
• Managers and Directors of Regulatory Submissions
• Those involved in clinical trials
Description
Orphan Drugs, designed to treat or prevent diseases
affecting fewer than 200,000 persons, have a special FDA
status. Fees are waived; exclusivity protection is provided and
there is some additional flexibility in experimentation and
approval. Orphan Drug Status is awarded after agency
review of a submitted Orphan Drug Application.
This two-day seminar provides hands on guidance, FDA
evaluation criteria and submissions checklists. Participants
who bring a planned submission topic to the course will
develop a comprehensive application outline over the two
days of the program.
By the end of the course you will have a specific outline for
your regulatory submission.