How to Apply for a Breakthrough Therapy Designation and Win It is dedicated to Breakthrough Therapy Designation (BTD).
How to Apply for a Breakthrough Therapy Designation and Win It 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 brings together:
- Quality Departments
- Regulatory Affairs Departments
- Clinical Personnel
- Research and Development Departments
- Auditors
- Manufacturing Departments
- Legal Personnel
- Clinical Research Associates (Monitors)