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

Jaksot(64)

Episode 16: Continuous Improvement of Quality Management Systems

Episode 16: Continuous Improvement of Quality Management Systems

Welcome to the 16th 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! In this we...

26 Helmi 201912min

Episode 15: Qualifications and Oversight of Contract Service Providers with Lisa Helmonds from MWA consulting

Episode 15: Qualifications and Oversight of Contract Service Providers with Lisa Helmonds from MWA consulting

Welcome to episode 2 of the 6-part series with Lisa Helmonds about virtual companies in the life sciences space. Lisa is the Vice President of MWA Consulting and has over 30 years of industrial traini...

12 Helmi 201922min

Episode 14: Key Elements of Virtual Life Sciences Companies with Lisa Helmonds from MWA consulting

Episode 14: Key Elements of Virtual Life Sciences Companies with Lisa Helmonds from MWA consulting

Welcome to the first episode back in the new year! Your host, Mandy Gervasio, and her co-host, Philippe Gaudreau, the CEO of Solabs, are back to start a very interesting new series. Continuing their...

29 Tammi 201926min

Episode 13: Recapping Industry Trends in 2018

Episode 13: Recapping Industry Trends in 2018

Welcome to the 13th episode of Automating Quality, the show that bridges the gap between automation and your quality management systems. Mandy Gervasio is your host, and she's on a mission to bring y...

11 Joulu 201814min

Episode 12: Validating a Cloud-based Solution with Philippe Gaudreau

Episode 12: Validating a Cloud-based Solution with Philippe Gaudreau

Welcome to the twelfth episode of Automating Quality, the show that bridges the gap between automation and your quality management systems. Mandy Gervasio is your host, and she's on a mission to brin...

27 Marras 201824min

Episode 11: How to Build an Effective Training Assessment Program with Brian McNamara

Episode 11: How to Build an Effective Training Assessment Program with Brian McNamara

Welcome to the eleventh 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! Mandy is...

13 Marras 201830min

Episode 10: Social and Collaborative Learning with Jay Turner

Episode 10: Social and Collaborative Learning with Jay Turner

Welcome to the tenth 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! Today, Mand...

29 Loka 201843min

Episode 9: Effective Training Methods for Millenials with Graham O'Keeffe

Episode 9: Effective Training Methods for Millenials with Graham O'Keeffe

Welcome to the ninth 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 joine...

15 Loka 201826min

Suosittua kategoriassa Liike-elämä ja talous

sijotuskasti
mimmit-sijoittaa
rss-rahapodi
psykopodiaa-podcast
rss-rahamania
herrasmieshakkerit
ostan-asuntoja-podcast
taloudellinen-mielenrauha
rss-sami-miettinen-neuvottelija
rahapuhetta
juristipodi
rss-startup-ministerio
rss-paasipodi
rss-draivi
pomojen-suusta
rss-lahtijat
rss-rikasta-elamaa
rss-pinnan-alla-kiehuu
rss-sisalto-kuntoon
rss-seuraava-potilas