Orphan Drug Application and Submission
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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.
Other Courses of Interest
Analytical Methods Validation for FDA Compliance
Sep 13 2010, Burlingame, CA
Analytical Methods Validation for FDA Compliance
Oct 25 2010, Amsterdam, The Netherlands
Best Practices in SAS Statistical Programming for Regulatory Submission
CMC Submissions in CTD Format
Sep 20 2010, Burlingame, CA
CMC Submissions in CTD Format
Nov 04 2010, Amsterdam, The Netherlands
Developing Specifications for Drug Substances (APIs) and Drug Products
Early Stage Clinical Studies for Drugs and Devices
INDs/NDAs/CTDs
Preparation, Packaging and Labeling of Clinical Trial Materials
Sep 27 2010, East Brunswick, NJ
Preparation, Packaging and Labeling of Clinical Trial Materials
Oct 18 2010, Amsterdam, The Netherlands
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