Pathways to Expedited Drug Development in the U.S. and Europe

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Premier Research

About this talk

Preparing for expedited drug development requires a thorough understanding of the steps that comprise a successful first-in-human study. It is 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. Register for this webinar to hear about: – 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 Please note: If Premier Research does not attend to your questions during the webinar, Premier Research may follow up after the presentation directly with a response.

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Premier Research is a clinical research company, dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors. Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.