A Pharmafocus webinar

Join us on Thursday 24th September 2020, 15:00 BST | 16:00 CEST | 10:00 EDT, when Dr Frank Casty, Judith Plon and Professor Steffen Thirstrup will guide you through the expedited regulatory pathways available in the EU and US and discuss how to effectively leverage these to accelerate and optimize your drug development program.

A timely market introduction is a critical component of any drug development strategy – not only from a commercial standpoint, where an earlier market entry can lead to a competitive advantage, but also for patients awaiting better treatment options.

Regulators worldwide have developed specialized pathways to expedite review and approval of new drugs. Navigating these pathways can be a daunting task for sponsors.

Partnering with experienced regulators both in the US and EU is critical to achieving expedited reviews since getting the strategy right, developing effective documentation, and preparing for regulatory interactions can make the difference between a standard regulatory review and a successful expedited review

Our panel will discuss:

  • Which pathways are available
  • When to apply for specific designations
  • What data are required and what to expect if the designation is granted
  • Best practice to create a successful strategy

Click here to book your place today!


 

Speakers

Dr Frank Casty

Senior Clinical Regulatory Advisor

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Judith Plon

Principal Consultant

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Steffen Thirstrup, MD

Advisory Board Director

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