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Zdrowie i gospodarka · 11.03.2004

Industry Exchange Workshop on FDA Clinical Trial Requirements; Public Workshop

The Food and Drug Administration (FDA) Detroit District, in cooperation with the Society of Clinical Research Associates, (SoCRA) is announcing a workshop on FDA clinical trial statutory and regulatory requirements. Topics for discussion include: Pre-IND(investigational new drug application) meetings and FDA meeting process, medical device, drug and biological product aspects of clinical research, investigator initiated research, informed consent requirements, adverse event reporting, how FDA conducts bioresearch inspections, ethics in subject enrollment, FDA regulation of Institutional Review Boards, FDA and confidence in the conduct of clinical research, and what happens after the FDA inspection. This 1 1/2-day workshop for the clinical research community targets sponsors, monitors, clinical investigators, institutional review boards and those who interact with them for the purpose of conducting FDA regulated clinical research. The workshop will include both industry and FDA perspectives on proper conduct of clinical trials regulated by FDA. Date and Time: The public workshop is scheduled for Wednesday, April 21, 2004 from 8:30 a.m. to 4:45 p.m. and Thursday, April 22, 2004, from

Source: Federal Register — Food and Drug AdministrationOpen original release →