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How to Effectively De-Risk your IND Process

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Manage episode 466194200 series 3517729
Content provided by Boyds. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Boyds 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://staging.podcastplayer.com/legal.

In this episode, Dr. Nick Meyers and Dr. Eric Hardter, discuss effective strategies for de-risking Investigational New Drug (IND) applications.

Discover key insights on how to navigate the complexities of IND submissions, including the importance of pre-IND meetings, optimizing your non-clinical and CMC packages, and understanding FDA expectations. Gain valuable tips on engaging with regulatory agencies, addressing potential issues, and ensuring your IND is well-prepared to avoid clinical holds. Whether you're a seasoned professional or new to the field, this episode offers practical advice to help streamline your drug development process.

  continue reading

20 episodes

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iconShare
 
Manage episode 466194200 series 3517729
Content provided by Boyds. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Boyds 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://staging.podcastplayer.com/legal.

In this episode, Dr. Nick Meyers and Dr. Eric Hardter, discuss effective strategies for de-risking Investigational New Drug (IND) applications.

Discover key insights on how to navigate the complexities of IND submissions, including the importance of pre-IND meetings, optimizing your non-clinical and CMC packages, and understanding FDA expectations. Gain valuable tips on engaging with regulatory agencies, addressing potential issues, and ensuring your IND is well-prepared to avoid clinical holds. Whether you're a seasoned professional or new to the field, this episode offers practical advice to help streamline your drug development process.

  continue reading

20 episodes

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