How to Apply for a Breakthrough Therapy Designation and Win It

How to Apply for a Breakthrough Therapy Designation and Win It is dedicated to Breakthrough Therapy Designation (BTD).

Topics

• 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

Who should Attend

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