Society of Clinical Research Associates-Food and Drug Administration; “Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance and Good Clinical Practice”

摘要

The Food and Drug Administration (FDA) is announcing the following conference: Educational Conference co-sponsored with the Society of Clinical Research Associates (SOCRA). The public workshop FDA's clinical trial requirements is designed to aid the Clinical Research Professional's understanding of the mission, responsibilities and authority of the FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among the FDA and clinical trial staff, investigators and institutional review boards (IRB). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices and biologics, as well as inspections of clinical investigators, of IRB, and of research sponsors. Date and Time: The conference will be held on March 11 and 12, (Wednesday and Thursday) 2015, from 8:00 a.m. to 5 p.m. Location: The conference will be held at the Holiday Inn Golden Gateway Hotel, 1500 Van Ness Ave., San Francisco, CA 91409, 415-441- 4000. Attendees are responsible for their own accommodations. Please mention SOCRA to receive the hotel room rate of $159.00 plus applicable taxes (available