PV Section 3 3.1: management of adverse events reports from spontaneous reporting 3.1.1: Single case Processing Activities: SOP 202 defines the responsibilities of LSU For…
Guidance for Industry • Submission of Clinical Trial Application for Evaluating Safety and Efficacy • Requirements for permission of New Drugs Approval • Post approval…
Slide 1 Structured Data Capture (SDC) Public Health Tiger Team Call will begin 3 min after the hour November 12, 2013 1 1 DRAFT: Not for distribution Public Health Tiger…
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Slide 1 Standards and Interoperability Public Health Tiger Team (PHTT) Jim Daniel, MPH John Saindon, DrHSc, MT Public Health Lead Health Scientist ONC CDC 1 1 DRAFT: Not…
Guidance for Industry • Submission of Clinical Trial Application for Evaluating Safety and Efficacy • Requirements for permission of New Drugs Approval • Post approval…