How to Prepare for an FDA Meeting: Making the Most of Pre-IND/IDE, pre-NDA and Other Critical Meetings 2015

  • 24-25 Sep 2015
  • Grand Hyatt San Francisco, CA, United States

Description

The How to Prepare for an FDA Meeting: Making the Most of Pre-IND/IDE, pre-NDA and Other Critical Meetings 2015 is a seminar that covers topics such as:

  • Creating rationale for FDA meetings
  • Different stages of FDA meetings: pre-IND, Pre-IDE, Pre-NDA, pre-PMA, End-of-Phase 2
  • Creating a meeting information package and its regulatory requirements
  • Requesting process for FDA meetings
  • FDA meeting follow ups
  • Logistics of an FDA Meeting

The How to Prepare for an FDA Meeting: Making the Most of Pre-IND/IDE, pre-NDA and Other Critical Meetings 2015 brings together:

  • Senior management executives (CEO, COO, CFO, etc.)
  • Regulatory affairs professionals
  • Clinical trial specialists
  • Project managers
  • People investing in FDA-regulated product development projects
  • Regulatory compliance associates and managers

Past Events

Important

Please, check "How to Prepare for an FDA Meeting: Making the Most of Pre-IND/IDE, pre-NDA and Other Critical Meetings" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device, Pharma
Industry: Food & Beverages
Science: Life Sciences & Biology
Technology: Biotechnology

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