Planning a product development program? Learn how to set the stage for success with our on-demand webinar series.
The steps you take in the earliest stages can profoundly influence your product’s path through development and marketing approval. When is the right time to engage regulators? Which paths to expedited development make sense for your product? Which areas of the world should you target in designing the study, and should you consider adaptive trial design?
Explore these and many other topics in a three-part webinar series from Premier Research. We provide tips for each stage of the development process, helping you to ask the right questions to keep your study on track.
Webinar 1: Pathways to Expedited Drug Development in the U.S. and Europe
- 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
Webinar 2: Considerations to Improve Patient Outcomes in Early Drug Development
- Developing a framework for handling multiple endpoints for the drug’s go-to-market label
- Determining the potential of adaptive design for optimizing the trial and evaluating the applicability of various adaptive design approaches
- Key interactions and questions to ask when seeking regulatory input of pivotal study designs
Webinar 3: Market Application and Lifecycle Management: The Road to Commercial Success
- The importance of developing a risk evaluation mitigation strategy, especially if risk factors require limited product distribution
- Making post-approval product changes, such as switching manufacturers
- The expanding role of pharmacovigilance in identifying potential safety issues