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Ep. 17: Renovating ICH guidelines to support the evolution of clinical research
Manage episode 297871922 series 2953454
Content provided by Kathy Vandebelt and Oracle Corporation. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Kathy Vandebelt and Oracle Corporation or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
The clinical research ecosystem has undergone an evolution over the past 18 months, and many want it to continue. To help set the industry on a solid path forward, ICH has created guidelines that provide direction on behaviors and actions to take. Recently, a specific set of these guidelines, ICH E6 Revision 3 and E8 Revision 1, have been referred to as being under renovation in response to the way work is done today and in the future.
In this episode, Kathy speaks with Andy Lawton, director at Risk-Based Approach Ltd., Crissy MacDonald, vice president of client delivery at Avoca Group, and Erika Stevens, principal at Recherche Transformation Rapide, about these specific ICH guidelines to learn what is new and improved about the quality by design approach, how this will impact the future of clinical research, and what you need to do to prepare.
43 episodes
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Manage episode 297871922 series 2953454
Content provided by Kathy Vandebelt and Oracle Corporation. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Kathy Vandebelt and Oracle Corporation or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
The clinical research ecosystem has undergone an evolution over the past 18 months, and many want it to continue. To help set the industry on a solid path forward, ICH has created guidelines that provide direction on behaviors and actions to take. Recently, a specific set of these guidelines, ICH E6 Revision 3 and E8 Revision 1, have been referred to as being under renovation in response to the way work is done today and in the future.
In this episode, Kathy speaks with Andy Lawton, director at Risk-Based Approach Ltd., Crissy MacDonald, vice president of client delivery at Avoca Group, and Erika Stevens, principal at Recherche Transformation Rapide, about these specific ICH guidelines to learn what is new and improved about the quality by design approach, how this will impact the future of clinical research, and what you need to do to prepare.
43 episodes
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Similar to The Latest Dose
BBC Radio 5 live’s award winning gaming podcast, discussing the world of video games and games culture.
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The American healthcare system is one of the most innovative in the world. But it’s also riddled with complex challenges, such as access to affordable medications, inefficiency and administrative burdens, and communication barriers between providers. There’s clearly a better way—and at Surescripts, we have a unique sightline into what that may be. In this series, host Melanie Marcus, Chief Marketing Officer of Surescripts, sits down with today’s most inspiring and innovative leaders in healt ...
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