*All times are in Eastern Time Zone
11:00 AM ET: FDA Welcome and Opening Comments
Eric Pittman, MBA, Program Division Director, BIMO Division II (West), 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 ET: Knock Knock - The FDA Inspection
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’.
12:30-12:40 PM Break and Q&A
12:40 - 1:40 PM ET: What FDA Expects in a Pharmaceutical Clinical Trial
Shubhangi (Gina) Mehta, PharmD, Consumer Safety Officer (Reviewer), Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, FDA
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.
1:40 - 2:10 Break and Q&A
2:10 PM ET: E-Systems in Clinical Trials – A Regulatory Perspective
Elena Boley, MD, MBA, FACP, Senior Medical Officer, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, FDA
Electronic systems (E-systems) play a critical role in the conduct of clinical trials, but when not adequately validated and maintained to ensure that they are fit for use for their intended purpose, they may significantly impact the quality and reliability of clinical trial data. This presentation will focus on key E-system considerations for ensuring data integrity and security, what critical E-systems and E-system controls FDA will review and evaluate during inspection, and an inspection case example that resulted in data reliability inspection findings.
11:00 AM ET: Building Quality into the System
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 - 12:10 PM ET: Q&A and Break
12:10 PM ET: Medical Device Aspects of Clinical Research
Christopher Gioffre, MA, MS, Consumer Safety Officer, Center for Devices and Radiological Health, FDA
The speaker will discuss how medical device regulatory requirements differ from pharmaceuticals and biologics. This will include an overview of medical device regulatory history, medical device classification, investigational device exemption (IDE), valid scientific evidence, regulatory submission process and how risk plays a prominent role in medical device route to market.
1:10 - 1:40 PM ET: Q&A and Break
1:40 PM ET: Investigational Review Boards
Dina Tallman PhD, MS, RDN, Investigator, BIMO Division II (West), 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.
11:00 AM ET: FDA Inspections of Clinical Investigations
Colleen Burke, Investigator, BIMO Division II (West), Office of Regulatory Affairs (ORA), FDA
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 - 12:10 PM ET: Q&A and Break
12:10 PM ET: Informed Consent Regulations
Dina Tallman, PhD, MS, RDN, Investigator, BIMO Division II (West), Office of Regulatory Affairs (ORA), FDA
This discussion considers regulations addressing the Informed Consent process and documentation from the investigator’s point of view.
1:10 - 1:40 PM ET: Q&A and Break
1:40 PM ET: Sponsor Oversight of Decentralized Clinical Trials
Jeanne Thai, MPA, Investigator, BIMO Division II (West), Office of Regulatory Affairs (ORA), FDA
Ms. Thai 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 speaker will discuss the Sponsor’s oversight of DCTs and key issues to consider.