2-day In-person Seminar: Preparing IND Submissions for Conventional and Orphan Products 2012

  • 11-12 Oct 2012
  • Hampton Inn Philadelphia City Center, PA, United States

Description

Topics
  • Overview of FDA’s IND requirements
  • Orphan Drugs and other Special
  • Logistics of IND Submission: Best Practices for timely good quality IND application
  • The Content and Format of an IND
  • Lecture 6: Presenting Pre-clinical and Clinical Information in the IND
  • CMC Section of an IND
  • Best Practices for Maintaining an IND with the FDA
  • FDA Meetings and Other Regulatory Interactions
Who should Attend
  • Orphan drug developers
  • Sponsors of INDs
  • Project management personnel
  • Supervisors, and lead workers in Regulatory Affairs
  • Manufacturing managers, supervisors & personnel
  • Senior management executives (CEO, COO, CFO, etc)
  • People investing in FDA-regulated product development projects
  • Clinical and preclinical laboratory managers

Past Events

Important

Please, check "2-day In-person Seminar: Preparing IND Submissions for Conventional and Orphan Products" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Marketing & Sales
Health & Medicine: Pharma

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