FDA HOLDING CLINICAL TRIALS WORKSHOP NEXT YEAR
The FDA's Los Angeles District is holding a workshop on the agency's statutory and regulatory requirements for clinical trials Feb. 78 in San Diego.
The two-day workshop, cosponsored by the Society of Clinical Research Associates, is aimed at sponsors, monitors, clinical investigators, institutional review boards (IRBs) and others concerned with FDA-regulated clinical research.
The workshop will cover both industry and FDA perspectives on the proper conduct of FDA-regulated clinical trials. Topics to be discussed include:
FDA regulation of clinical research;
Medical device, drug, biologic product and food aspects of clinical research;
Investigator-initiated research;
Pre-investigational new drug application meetings and the FDA meeting process;
Informed consent requirements;
The ethics of subject enrollment;
FDA regulation of IRBs;
Electronic records requirements;
Adverse event reporting;
How the FDA conducts bioresearch inspections; and
What happens after an FDA inspection.
The notice of the workshop can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/ora0619-nm00001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/ora0619-nm00001.pdf).
Upcoming Events
-
11Jul
-
18Jul
-
21Oct