Preparing for expedited drug development requires a thorough understanding of the steps that comprise a successful first-in-human study. It’s essential to start with the end firmly in mind, identifying the target population and defining elements of the program long before you dose the first patient. This webinar will show you where to start and how to envision the end, describe the U.S. and European pathways for accelerating development and equip you to engage with regulators effectively.
The webinar will explore the target product profile — the drug development program summary that defines drug labeling concepts and commercial goals — and why the profile must include a development program plan that supports its objectives.
Topics will include:
- Understanding the multiple and essential interfaces with the Food and Drug Administration and European Medicines Agency
- The importance of having a pre-IND meeting with the FDA to minimize risk upfront, when mitigation efforts are most effective
- Avenues for expedited product review in the U.S. and Europe: what approaches are available, and how to use them to your best advantage
Sameena Sharif, President, RPI, A Division of Premier Research
Naomi Kautz, Senior Director, Regulatory Affairs, RPI, A Division of Premier Research
Beatriz Criado, Associate Director, Regulatory Affairs, Premier Research