How to Apply for a Breakthrough Therapy Designation and Win It

How to Apply for a Breakthrough Therapy Designation and Win It is a webinar that covers topics such as:

  • Best practices for format, style and organization of the BTD application
  • Assessing the eligibility of a product for BTD
  • Pros and cons of applying for the BTD
  • Best time in the development timeline to apply for the BTD
  • Managing public information related to the BTD
  • What to do when the BTD is rejected: process to re-apply and appeal
  • Common errors and potential solutions

How to Apply for a Breakthrough Therapy Designation and Win It is intended for:

  • Quality Departments
  • Regulatory Affairs Departments
  • Clinical Personnel
  • Research and Development Departments
  • Auditors
  • Manufacturing Departments
  • Legal Personnel
  • Clinical Research Associates (Monitors)

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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