8:00–8:30 - Registration and Continental Breakfast
8:30–8:45 - SOCRA Welcome
8:45–9:15 - FDA Welcome and Opening Comments
Audrey Vigil, Director, Investigations, Bioresearch Monitoring, West, Office of Regulatory Affairs, U.S. Food and Drug Administration
Ms. Vigil 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.
9:15–9:30 - Break (with opportunity for conversations and discussion)
9:15–10:30 - Knock Knock - The FDA Inspection
Audrey Vigil, Director, Investigations, Bioresearch Monitoring, West, Office of Regulatory Affairs, U.S. Food and Drug Administration
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’.
10:30–10:45 - Break (with opportunity for conversations and discussion)
10:45–11:30 - What FDA Expects in a Pharmaceutical Clinical Trial
LCDR Iram Hassan, PhD, Investigator, 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. LCDR Hassan 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. FDA Conduct of Clinical Investigator Inspections
11:30–12:30 - Medical Device Aspects of Clinical Research
Christopher Gioffre, MA, MS, Consumer Safety Officer, Division of Clinical Evaluation and Quality, FDA
Mr. Gioffre 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.
12:30–1:30 - Lunch (Provided)
1:30–2:30 - Working with FDA’s Center for Biologics Evaluation and Research
CDR Peter Lenahan, DC, PhD, MPH, Regulatory Officer, Bioresearch Monitoring Branch, Division of Inspections and Surveillance, Center for Biologics Evaluation and Research, FDA
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.
2:30–3:15 - A Continuing Evolution of Ethical Considerations in Clinical Research
Alyssa K. Gateman, MPH CCRP, Executive Director, Yale Cancer Center Clinical Trials Office
Over time ethical considerations have evolved to address identified violations and challenges in the conduct of clinical research. This talk will review some of the foundational clinical research ethical regulations and guidance, identify ethical principles that create the framework for evaluating clinical studies, and examine diversity and several strategies for improving diversity as examples of our continued need to evolve in our understanding and applications of clinical research ethics.
3:15–3:30 - Break
3:30–4:30 - Building Quality into the System
Chrissy Cochran, PhD, Program Director, OBIMO, 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. Dr. Cochran 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.
4:30–5:00 - Question and Answer Session / Panel Discussion
Day Two: Wednesday
8:00–8:30 - Registration and Continental Breakfast
8:30-9:15 - FDA Conduct of Clinical Investigator Inspections
Samson Oluseye, Consumer Safety officer , ORA/Office of Bioresearch Monitoring Operations, Div. 2 (West), FDA
Mr. Oluseye 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.
9:15-10:15 - IRB Regulations and FDA Inspections
Chrissy Cochran, PhD, Program Director, OBIMO, FDA
During this session, Dr. Cochran will discuss FDA regulations covering the operations of Institutional Review Boards, the procedures used by FDA investigators during inspections of IRBs, the Common Rule, and FDA enforcement options.
10:15-10:30 - Break (with opportunity for conversations and discussion)
10:30-11:15 - eSystems Used in Clinical Trials – A Regulatory Perspective
Mathew Thomas, MD, Senior Policy Advisor, 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.
11:15 – 12:15 - Informed Consent Regulations
CheRon Portee, Consumer Safety officer , ORA/Office of Bioresearch Monitoring Operations, Div. 2 (West), FDA
This discussion considers regulations addressing the Informed Consent process and documentation from the investigator’s point of view.
12:15 – 1:00 - Lunch (Provided)
1:00-2:00 - Decentralized Clinical Trials
LCDR Christina Mello, Consumer Safety officer , ORA/Office of Bioresearch Monitoring Operations, Div. 2 (West), 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 speaker will discuss the oversight of DCTs and key issues to consider.
2:00 – 2:30- Break (with opportunity for conversation and discussion)
2:30 – 3:30 - BIMO Compliance and Enforcement
Chrissy Cochran, PhD, Program Director, OBIMO, FDA
This presentation will cover Fiscal Year 2021 metrics and selected regulatory actions taken by the Agency.
3:30- 4:00 - Question and Answer Session / Panel Discussion