This webinar will discuss the importance of a governance process that facilitates rich TPP/TPC discussions across all functions in a company and with the FDA. We will hear from each of the presenters who are representing a different stakeholder group how the TPP/TPC impacts them and how they use this information to inform drug product development:
- Drug product development – how the TPP/TPC informs trial design
- Regulatory development – how and when to engage FDA in the TPP/TPC process for the best outcome – what groups at FDA need to be engaged and why
- Drug product labeling – considerations for timing and innovative labeling concepts
- Marketed product commercialization – when is the optimal time to input into the process; and when is it too late
- FDA – Perspectives on engaging with the FDA during drug product development – how to use the TPP/TPC throughout the development process with FDA
Event Details Available Here.