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

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Manage episode 421270305 series 2877522
Kandungan disediakan oleh Citeline. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh Citeline atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.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

1398 episod

Artwork
iconKongsi
 
Manage episode 421270305 series 2877522
Kandungan disediakan oleh Citeline. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh Citeline atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.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

1398 episod

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