Combination Products: How to Get Your Combination Product Approved and onto the US Marketplace 2014

  • 30-31 Oct 2014
  • Courtyard San Francisco Airport/Oyster Point Waterfront, CA, United States

Description

Combination Products: How to Get Your Combination Product Approved and onto the US Marketplace 2014 is a conference that covers topics such as:

  • How to navigate the FDA Combination Product system
  • What a Combination Product is
  • The FDA Office of Combination products
  • The FDA Combination Product Process
  • How to prepare a Request for Designation
  • Mode of action and primary mode of action
  • GMPs for Combination products
  • User Fees for Combination products
  • Post-Approval Modifications

Combination Products: How to Get Your Combination Product Approved and onto the US Marketplace 2014 is intended for:

  • Research Personnel
  • Clinical Personnel
  • Quality Personnel
  • Personnel who require an understanding of the FDA Combination Product Process
  • Regulatory Affairs Personnel
  • Manufacturing Personnel

Past Events

Important

Please, check "Combination Products: How to Get Your Combination Product Approved and onto the US Marketplace" official website for possible changes, before making any traveling arrangements

Event Categories

Education: Training
Health & Medicine: Healthcare, Medical technology, Pharma

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