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Regulatory Considerations for Investigational New Drug(IND) applications to USA FDA

ÀϽà: 2023.4.12. 4pm-5:30pm

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- Structure and content of an IND & submission pathway(INDÁ¦Ãâ ¹æ¹ýÀÇ ±¸Á¶ ¹× ³»¿ë)

- FDA expectation of scientific & technical content (°úÇÐÀû ¹× ±â¼úÀû ³»¿ë¿¡ ´ëÇÑ FDAÀÇ ¿ä±¸)

- Other development considerations for the IND, how to increase your probability of success (IND¿¡ ´ëÇÑ ±âŸ °³¹ß °í·Á »çÇ×, ¼º°ø°¡´É¼ºÀ» ³ôÀÌ´Â ¹ý)

- FDA meetings and maximizing successful FDA interactions (FDA ¹ÌÆà ¹× ¼ÒÅë ±Ø´ëÈ­)

- How to operationalize the IND, eCTD publishing & IND maintenance (IND ¿î¿µ ¹æ¾È, eCTD °ÔÀç ¹× À¯Áö°ü¸® ¹æ¾È)

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Andrew Willis, Chief Development and Regulatory Officer LIfT BioSciences  

Jasbir Chohan,  Executive Vice President at Framework Solutions 

Christine Grew, Director of Regulatory Affairs at Framework Solutions

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