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 a conversation with 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 about defining what are Real-World Data and Real-World Evidence (RWD & RWE).
01:13 Introducing today’s guest: Ben Locwin
03:03 Philippe discusses the link between Real-World Data and its connection with technology
05:05 Ben defines Real-World Data and Real-World Evidence
10:28 Philippe discusses the importance of the integrity of data gathered from different sources
12:18 The importance of looking at the data with a specific hypothesis in mind
15:45 There is a lack of standardizing in data that leaves some concern
17:07 What is the FDA looking for regarding Real-World Data and Real-World evidence?
20:00 Ben shares his closing thoughts on the topic
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