FDA`s Expedited Development and Approval Programs: Taking the Mystery out of Expedited Approvals 2017

  • 25 May 2017
  • Webinar

Description

FDA`s Expedited Development and Approval Programs: Taking the Mystery out of Expedited Approvals 2017 is a webinar that covers topics such as:

  • Best practices for format, style and organization of the each type of expedited approval pathway
  • Assessing the eligibility of a product for an expedited approval pathway: drugs, biologics and medical devices
  • Pros and cons of applying for each designation
  • Best time in the development timeline to apply for each designation
  • Managing public information related to each expedited approval pathway
  • What to do when a given designation is rejected: general processes to re-apply and appeal
  • Common errors and potential solutions

FDA`s Expedited Development and Approval Programs: Taking the Mystery out of Expedited Approvals 2017 is intended for:

  • Senior management executives (CEO, COO, CFO, etc)
  • Regulatory affairs professionals
  • Clinical trial specialists
  • Project Managers
  • People investing in drug and biologics products
  • Regulatory Compliance Associates and Managers

Past Events

Important

Please, check "FDA`s Expedited Development and Approval Programs: Taking the Mystery out of Expedited Approvals" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical laboratories, Medical technology, Pharma
Industry: Food & Beverages
Technology: Biotechnology

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