Virtual FDA Conference: FDA Clinical Trial Requirements, Regulations, Compliance and GCP Conference
*All times are in Eastern Time Zone
11:00 AM ET: FDA Welcome and Opening Comments
The speaker will address the mission of FDA and the role of the FDA District Office and the BIMO Program Division relative to the Bioresearch Monitoring Program.
11:30 AM ET: Knock Knock - The FDA Inspection
What do you do when a regulatory agency knocks on the door? Turn off the lights? Panic? If you’re prepared, it should be an exercise to ensure that your predesigned systems are working correctly. This presentation will cover FDA Inspections; how to prepare for them and what to do, and expect after the inevitable, ‘Knock, Knock’.
12:30 PM ET: Working with FDA's Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research regulates research, development, production, and marketing of biologic drug products. This session will consider the organization, mission, and activities of the Center as well as the Center’s inspection program.
2:30 PM ET: Medical Device Aspects of Clinical Research
The speaker will discuss how studies with investigational devices differ from those with drugs and biologics. These differences can create issues, especially for companies that may have dealt only with pharmaceuticals in the past. There are some similarities between devices and drugs and biologics. Device differences include the nature of firms and studies, statutory distinctions, and regulatory distinctions.
11:00 AM ET: Introduction to Investigational New Drugs
The speaker will introduce the IND Process and Clinical Trial Regulations, discuss how to determine if an IND is needed for a clinical trial, summarize the types of INDs, and share information on the Pre-IND Consultation process at the FDA.
12:30 PM ET: 21 CFR Part 11 Compliance
This session offers discussion of Part 11 compliance, including scope, implementation, and definitions. The regulations in Part 11 establish the criteria under which the agency considers electronic records, handwritten and electronic signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
2:30 PM ET: What FDA Expects in a Pharmaceutical Clinical Trial
The regulations regarding clinical trials are clear and published. FDA guidance, policies, and requirements abound. The speaker will offer a discussion of the FDA’s oversight of the conduct of pharmaceutical clinical research, including trends FDA has found when comparing research with FDA standards for design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
11:00 AM ET: COVID-19 Guidance Updates
12:30 PM ET: Clinical Investigations
The speaker will explain the responsibilities of the Clinical Investigator including the regulations and guidelines to which the FDA expects the Clinical Investigator to adhere in their participation, review and oversight of clinical investigations.
2:30 PM ET: Informed Consent
This discussion considers regulations addressing the Informed Consent process and documentation from the investigator’s point of view.