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Colorado Chapter Webcast: Expedited Development, Review & Innovation Incentives for the US Market

1.0
RAC Credits
Monday, 20 July 2020 (12:00 PM) - Monday, 20 July 2020 (1:00 PM) Mountain Time (US & Canada)

Member: FREE
Nonmember: $20

Your participation in the regulatory community is vital. Currently, RAPS Chapter in-person events are converted to webcasts so that regulatory professionals have online access to valuable knowledge necessary to understand the daily impact on our industry. RAPS is offering this webcast for free to members and $20 for non-members.

Description

Expediated pathways, designed to provide drugs to patients sooner, are being used more often.  These “express lanes” are open to products containing both significant benefit over available therapies and filling an unmet need. 

This presentation will examine the opportunities and incentives available to sponsors to expedite the development and approval specifically of drugs and biologics, with a focus on the United States. 

The topics covered will include: 

  • FDA programs to accelerate development and approval of drugs and biologics for serious and unmet need
  • Approval statistics for expedited programs
  • Priority Review Vouchers - history and use
  • Exclusivity incentives

A Q&A session will be provided at the end.

This event is brought to you by the RAPS Colorado chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.

This webcast is available to RAPS members for free. RAPS membership provides vital information for regulatory professionals, as well as a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. 

Find out more about RAPS membership today.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation. 

Featured Speakers:
Linda Bowen, MSc., RAC, FRAPS, head of regulatory policy and intelligence, Seattle Genetics

 

Register