A Comprehensive Review of Regulatory Procedures for New Drug Applications in the US

ONLY 5 SEATS LEFT! This course will enhance understanding and be beneficial to persons who work in clinical research, data management, biostatistics, basic research, project management and marketing.

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SESSION 1: THE NDA IN CTD FORMAT

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, United States

Michael Hamrell, PHD, RAC

President

MORIAH Consultants, United States

Getting from the IND to the NDA
Types of NDAs

Speaker(s)

THE NDA IN CTD FORMAT

Michael Hamrell, PHD, RAC

MORIAH Consultants, United States

President

A Comprehensive Review of Regulatory Procedures for New Drug Applications in the US

SESSION 1: THE NDA IN CTD FORMAT

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

Michael Hamrell, PHD, RAC

Speaker(s)

THE NDA IN CTD FORMAT

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