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

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

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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Episode 8: The Specificities of GCP Quality Systems with Nathalie Bourgouin

Episode 8: The Specificities of GCP Quality Systems with Nathalie Bourgouin

Welcome to the eighth episode of 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! She's join...

1 Loka 201822min

Episode 7: The Philosophy of Quality with Dr. Richard Prince

Episode 7: The Philosophy of Quality with Dr. Richard Prince

Welcome to the seventh episode of 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, and to pr...

17 Syys 20181h 3min

Episode 6: Data Integrity with Rich Greer

Episode 6: Data Integrity with Rich Greer

Welcome to the sixth episode of Automating Quality. Today's topic is data integrity — a current, hot-topic in the regulated space. Mandy is your host, and she's on a mission to bring you hot industry ...

3 Syys 201824min

Episode 5: The Do's and Dont's of Change Management with Rachel Fountain

Episode 5: The Do's and Dont's of Change Management with Rachel Fountain

Welcome to the fifth episode of Automating Quality. Today's topic is change management — picking up the conversation from their first episode on the topic. Mandy is joined by her co-host, Philippe Gau...

20 Elo 201817min

Episode 4: Measuring Operational Effectiveness with Alan Greathouse

Episode 4: Measuring Operational Effectiveness with Alan Greathouse

Welcome to the fourth episode of Automating Quality. Today's topic is operational effectiveness. Mandy is joined by her co-host, Philippe Gaudreau, CEO of Solabs; and their guest this week, Alan Great...

6 Elo 201820min

Episode 3: Phase Appropriate Quality with Mary Senica

Episode 3: Phase Appropriate Quality with Mary Senica

Welcome to the third episode of Automating Quality. Today's topic is phase appropriate quality — a topic that is especially relevant for anyone in the life sciences industry. Mandy is joined by her co...

23 Heinä 201833min

Episode 2: Optimizing Compliance When Implementing an Automated Training Solution with Jay Turner

Episode 2: Optimizing Compliance When Implementing an Automated Training Solution with Jay Turner

Welcome to the second episode of Automating Quality. In this episode, Mandy is joined by Jay Turner of EduJay LLC. Jay's a self-proclaimed learning and development ninja at his latest entrepreneurial ...

8 Heinä 201839min

Episode 1: Change Management with Rachel Fountain

Episode 1: Change Management with Rachel Fountain

Welcome to the first episode of Automating Quality. Today's show is focused on change management — a vital topic for the Life Sciences and regulated industry. Your host is Mandy Gervasio, Sales Engine...

25 Kesä 201826min

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