*All times are in Eastern Time Zone
11:00 to 11:30 AM ET: FDA Welcome and Opening Comments (0.5 CE)
Eric Pittman, MBA, Program Division Director, BIMO West Division II, Office of Regulatory Affairs (ORA), FDA
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 to 12:45 PM ET: Knock Knock - The FDA Inspection (1.25 CE)
Eric Pittman, MBA, Program Division Director, BIMO Division II (West), Office of Regulatory Affairs (ORA), FDA
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’.
12:45-1:00 PM: Beak and Q&A
1:00 - 2:00 PM ET: The 5Cs, Responding to an FDA-483 (1.0 CE)
Eric Pittman, MBA, Program Division Director, BIMO Division II (West), Office of Regulatory Affairs (ORA), FDA
The 5Cs discusses the process by which a firm can submit an FDA-483 response that is Clear, Concise, Compliant, Comprehensive, and Compelling. Mr. Pittman will help attendees with responding to a 483, understand the timeframes to respond and being able to identify relevant records they can use in their responses.
2:00 - 2:15 Break and Q&A
2:15 PM to 3:15 PM ET: INDs, IDEs, and the ABCs of Exemptions in Research (1.0)
Eric Pittman, MBA, Program Division Director, BIMO Division II (West), Office of Regulatory Affairs (ORA), FDA
Mr. Pittman will review differences in FDA applications, identify situations where exemptions apply, and understand which regulations apply.
3:15 PM to 3:45 PM ET: Q+A Session (0.5 CE)
11:00 AM to 12:00 PM ET: Building Quality into the System (1.0 CE)
Eric Pittman, MBA, Program Division Director, BIMO Division II (West), Office of Regulatory Affairs (ORA), FDA
Quality in clinical studies is an overarching objective that must be built into a study at the beginning through proactive compliance, rather than attempting to inspect the quality into a study after it has been conducted. This talk will focus on the ways to increase the quality of the data generated during a study and will touch on what FDA Investigators look at during inspections to ensure the quality of data submitted to the Agency.
12:00 - 12:15 PM ET: Q&A and Break
12:15 to 1:15 PM ET: Working with FDA’s Center for Biologics Evaluation and Research (1.0 CE)
Dennis Cato, Associate Director of Bioresearch Monitoring, Center for Biologics Evaluation and Research, FDA
The Center for Biologics Evaluation and Research regulates research, development, production, and marketing of biologic drug products. Dr. Tran will consider the organization, mission, and activities of the Center as well as the Center’s inspection program.
1:15 - 1:45 PM ET: Q&A and Break
1:45 to 2:45 PM ET: Investigational Review Boards (1.0 CE)
Dina Tallman, PhD, MS, RDN, Consumer Safety Officer, BIMO West Divison 2, Office of Regulatory Affairs (ORA), FDA
This presentation will provide insight into IRBs, their inspections, regulations, and common deficiencies. Attendees will take away tools for understanding the process of IRB inspections as well as some common errors found by FDA.
2:45 to 3:45 PM ET: Q+A Session (0.5 CE)
11:00 AM to 12:00 PM ET: Clinical Investigations (1.0 CE)
Chelsea Lamm, Investigator, BIMO-W
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.
12:00 - 12:15 PM ET: Q&A and Break
12:15 to 1:15 PM ET: Informed Consent (1.0 CE)
Dina Tallman, PhD, MS, RDN, Consumer Safety Officer, BIMO West Division 2, Office of Regulatory Affairs (ORA), FDA
This discussion considers regulations addressing the Informed Consent process and documentation from the investigator’s point of view.
1:15 - 1:45 PM ET: Q&A and Break
1:45 to 2:45 PM ET: Sponsor Oversight of Decentralized Clinical Trials (1.0 CE)
Eric Pittman, MBA, Program Division Director, BIMO Division II (West), Office of Regulatory Affairs (ORA), FDA
The speaker will provide an overview of decentralized clinical trials (DCTs) along with the FDA’s current regulations and guidance. The presentation will address the perceived and/or actual benefits and challenges of decentralized clinical trials. The presenter will discuss the Sponsor’s oversight of DCTs and key issues to consider.
2:45 to 3:45 PM ET: Q+A Session (1.0)