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Ep. 17: Renovating ICH guidelines to support the evolution of clinical research

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Manage episode 297871922 series 2953454
内容由Kathy Vandebelt and Oracle Corporation提供。所有播客内容(包括剧集、图形和播客描述)均由 Kathy Vandebelt and Oracle Corporation 或其播客平台合作伙伴直接上传和提供。如果您认为有人在未经您许可的情况下使用您的受版权保护的作品,您可以按照此处概述的流程进行操作https://zh.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.

  continue reading

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Manage episode 297871922 series 2953454
内容由Kathy Vandebelt and Oracle Corporation提供。所有播客内容(包括剧集、图形和播客描述)均由 Kathy Vandebelt and Oracle Corporation 或其播客平台合作伙伴直接上传和提供。如果您认为有人在未经您许可的情况下使用您的受版权保护的作品,您可以按照此处概述的流程进行操作https://zh.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.

  continue reading

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