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Holiday Inn London Kensington Forum

Oct 16, 2017 1:30 PM - Oct 17, 2017 6:00 PM

97 Cromwell Road, London, SW7 4DN, United Kingdom

A Comprehensive Review of Regulatory Procedures for Investigational New Drugs in the US

This course is designed for persons with a background in pre-clinical research, clinical research, quality assurance or academia, who need knowledge of the US regulatory processes.

SESSION 5: IND IN DETAIL – MODULES 4 & 5

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, United States

Michael  Hamrell, PhD, RAC

Michael Hamrell, PhD, RAC

President

MORIAH Consultants, United States

  • IND item: Non-clinical pharmacology and toxicology – Safety Section
  • IND item: Previous human experience
  • IND item: Additional information

Speaker(s)

Carol H. Danielson, DrPH, MS, RAC

IND IN DETAIL – MODULES 4 & 5

Carol H. Danielson, DrPH, MS, RAC

Regulatory Advantage, LLC, United States

President

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