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SESSION 3: THE NDA IN CTD FORMAT (CONTINUED)
Session Chair(s)
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
Michael Hamrell, PHD, RAC
President
MORIAH Consultants, United States
- Module 5
- Structure and contents of clinical study reports - E3
- Module 2
- Safety update reports (CTD module 5)
Speaker(s)
THE NDA IN CTD FORMAT (CONTINUED)
Michael Hamrell, PHD, RAC
MORIAH Consultants, United States
President
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