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Philadelphia Chapter Webcast: FDA Framework on RWE Generation

1.0
RAC Credits
Friday, 11 December 2020 (12:00 PM) - Friday, 11 December 2020 (1:00 PM) Eastern 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

The Food and Drug Administration (FDA) has created a framework for evaluating the potential use of real-world evidence (RWE). This framework will help support the approval of a new indication for a drug already approved under section 505(c) of the FD&C Act or to help support or satisfy drug post approval study requirements. 

In addition to drug and biological products approved under section 505(c), this framework's intention is for application to biological products licensed under the Public Health Service Act. FDA's RWE Program provides guidance documents to assist developers interested in using real-world data (RWD) to develop RWE to support Agency regulatory decisions. 

Learning objectives of this webcast includes: 

  • Explaining supporting the FDA’s regulatory decisions on effectiveness
  • Discussing the use of trials or studies with RWD/RWE for effective decisions
  • Engaging attendees in assessing the fitness of RWD for use in regulatory decision

A Q&A session will be included at the end of the webcast. 

This event is brought to you by the RAPS Philadelphia 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 Speaker:
Kenneth Quinto, M.D., M.P.H., senior medical advisor, Real World Evidence Analytics, FDA