Conducting Successful FDA Meetings to Negotiate Product Development and Approval: 2-day In-person Seminar 2013

  • 25-26 Apr 2013
  • Grand Hyatt San Francisco, CA, United States

Description

Topics
  • How to prepare an FDA meeting request in accordance with recent FDA proposed guidelines
  • The types of FDA meetings that FDA welcomes
  • Types of FDA persons who conduct meetings with Industry
  • The format and contents of a meeting request
  • Preparing an agenda for the meeting
  • Type of questions appropriate to ask FDA, and inappropriate to ask FDA
  • How to prepare your team for the FDA meeting
  • Who should attend the meeting representing your firm
  • How to judge your success after the FDA meeting
  • How to serve as the central spokesperson of your team at the FDA meeting
  • Preparing a meeting summary for FDA
Who should Attend
  • Marketing
  • Regulatory Affairs
  • Legal
  • Medical Affairs
  • Regulatory Compliance

Past Events

Important

Please, check "Conducting Successful FDA Meetings to Negotiate Product Development and Approval: 2-day In-person Seminar" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Pharma
Science: Life Sciences & Biology

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