Pathways to Expedited Drug Development in the U.S. and Europe, Upcoming Webinar Hosted by Xtalks

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In this free webinar, attendees will understand the multiple and essential interfaces with the FDA and European Medicines Agency as well as the importance of having a pre-IND meeting with the FDA to minimize risk upfront. The featured speakers will discuss avenues for expedited product review in the U.S. and Europe: what approaches are available, and how to use them to your best advantage.

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.

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.

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

Join expert speakers from Premier Research, Sameena Sharif, President, RPI, Naomi Kautz, Director, Regulatory Affairs and Beatriz Criado, Associate Director, Regulatory Affairs, in a live webinar on Wednesday, March 24, 2021 at 11am EDT (4pm BST/UK).

For more information, or to register for this event, visit Pathways to Expedited Drug Development in the U.S. and Europe.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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Sydney Perelmutter
Xtalks
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