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Enjoys making presentations and Webinars on a variety of GCP subjects such as Investigator Responsibility in Clinical Research, The Role of Adverse Event Determination and Reporting in Drug Safety, Data and Safety Monitoring Board set-up and use, Importance of Conflict of Interest Avoidance, What is "GCP", How to Document to have a good FDA Inspection, How to prepare for an FDA BIMO Inspection, The Importance of effective Pharmacovigilance.
Specialties
Safety monitoring is mandated in 21 CFR 312.50, 312.56, and 600.80 for drugs and biologics and 21 CFR 812.40 and 812.46 for devices. Depending on the nature of the test agent, the length of the study or the number of sites conducting the clinical study, the " ...