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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 8: ACTIVITIES AND SUBMISSIONS AFTER THE ORIGINAL IND

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

  • Amendments to the IND
  • Annual reports
  • Non-standard INDs
  • IND administrative actions

Speaker(s)

Michael  Hamrell, PhD, RAC

ACTIVITIES AND SUBMISSIONS AFTER THE ORIGINAL IND

Michael Hamrell, PhD, RAC

MORIAH Consultants, United States

President

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