Episode 40: What are Real-World Data and Real-World Evidence? With Ben Locwin

Automating Quality

Konten disediakan oleh SOLABS, Mandy Gervasio, and Philippe Gaudreau. Semua konten podcast termasuk episode, grafik, dan deskripsi podcast diunggah dan disediakan langsung oleh SOLABS, Mandy Gervasio, and Philippe Gaudreau atau mitra platform podcast mereka. Jika Anda yakin seseorang menggunakan karya berhak cipta Anda tanpa izin, Anda dapat mengikuti proses yang diuraikan di sini https://id.player.fm/legal.

2y ago 22:01

MP3•Beranda episode

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).

Key Takeaways

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

58 episode

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