Episode 41: Framework for the FDA's Real-World Evidence Program with Ben Locwin

Automating Quality

Treść dostarczona przez SOLABS, Mandy Gervasio, and Philippe Gaudreau. Cała zawartość podcastów, w tym odcinki, grafika i opisy podcastów, jest przesyłana i udostępniana bezpośrednio przez SOLABS, Mandy Gervasio, and Philippe Gaudreau lub jego partnera na platformie podcastów. Jeśli uważasz, że ktoś wykorzystuje Twoje dzieło chronione prawem autorskim bez Twojej zgody, możesz postępować zgodnie z procedurą opisaną tutaj https://pl.player.fm/legal.

2y ago 18:22

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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!

Today’s episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA.

The topic of today’s discussion is the Real-World Evidence framework as defined by the FDA. We highly recommend listening to the previous episode on Real-World Data and Real-World Evidence before diving into this one.

Key Takeaways

00:17 Mandy introduces Ben back to the show

01:13 Today’s topic is the Real-World Evidence framework

02:24 What is the FDA’s definition of Real-World Evidence?

06:50 What is being looked at for the framework?

09:16 What are the 4 Vs of data?

11:18 How do you define your hypotheses in advance when looking at data?

15:44 Mandy reflects on today’s discussion

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