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Innhold levert av Kathy Vandebelt and Oracle Corporation. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Kathy Vandebelt and Oracle Corporation eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.player.fm/legal.
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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
Innhold levert av Kathy Vandebelt and Oracle Corporation. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Kathy Vandebelt and Oracle Corporation eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.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

43 episoder

Artwork
iconDel
 
Manage episode 297871922 series 2953454
Innhold levert av Kathy Vandebelt and Oracle Corporation. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Kathy Vandebelt and Oracle Corporation eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.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

43 episoder

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