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Navigating IND Applications & Pre-IND Meetings: Key Considerations And Misconceptions

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Manage episode 421270305 series 2877522
内容由Citeline提供。所有播客内容(包括剧集、图形和播客描述)均由 Citeline 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
Advancing Investigational New Drugs (INDs) can be a complex process, especially for smaller companies. Listen to your free podcast now as Marcus Delatte, PhD, Vice President at Allucent and Harshini Neelakantan, Executive Director at Ridgeline Therapeutics discuss best practices and considerations for leveraging your pre-IND meeting and submitting a successful IND application. Listen now for insights into: • Current trends and challenges related to IND submissions • The purpose and benefits of pre-IND meetings with regulatory bodies • Indicators that should prompt companies to request a pre-IND meeting • The role of consultants in supporting sponsors in pre-IND meetings • Getting the most from your pre-IND meeting and tips for IND application success • How IND submissions will evolve in the future
  continue reading

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Manage episode 421270305 series 2877522
内容由Citeline提供。所有播客内容(包括剧集、图形和播客描述)均由 Citeline 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
Advancing Investigational New Drugs (INDs) can be a complex process, especially for smaller companies. Listen to your free podcast now as Marcus Delatte, PhD, Vice President at Allucent and Harshini Neelakantan, Executive Director at Ridgeline Therapeutics discuss best practices and considerations for leveraging your pre-IND meeting and submitting a successful IND application. Listen now for insights into: • Current trends and challenges related to IND submissions • The purpose and benefits of pre-IND meetings with regulatory bodies • Indicators that should prompt companies to request a pre-IND meeting • The role of consultants in supporting sponsors in pre-IND meetings • Getting the most from your pre-IND meeting and tips for IND application success • How IND submissions will evolve in the future
  continue reading

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