8:00–8:30 - Registration and Continental Breakfast
8:30–8:45 - SOCRA Welcome
8:45–9:15 - FDA Welcome and Opening Comments
Eric Pittman, MBA, Program Division Director, BIMO Division II (West), Office of Regulatory Affairs (ORA), FDA
Mr. Pittman will address the mission of FDA and the role of the Office of Bioresearch Monitoring Operations (OBIMO) Program Division relative to the Bioresearch Monitoring Program.
9:15–11:00 - 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’.
11:00–11:15 - Break (with opportunity for conversations and discussion)
11:15–12:30 - Marketing Applications, the Review Process, and FDA’s GCP Compliance Review for NDAs/BLAs
Callie Cappel-Lynch, PharmD, RAC, Chief, Project Management Staff, Office of Regulatory Operations, Office of New Drugs, Center for Drug Evaluation and Research, FDA
Cara Alfaro, PharmD, Clinical Analyst, Good Clinical Practice Assessment Branch, Office of Scientific Investigations, Center for Drug Evaluation and Research, FDA
The regulations regarding clinical trials are clear and published. FDA guidance, policies, and requirements abound. Dr. Cappel-Lynch will discuss the review process for NDA and BLA submissions. Dr. Alfaro will discuss Good Clinical Practice inspections and the role of the Office of Scientific Investigations in the evaluation of data integrity and study participant protections in the review process.
12:30–1:30 - Lunch (Provided)
1:30–2:30 - Working with FDA’s Center for Biologics Evaluation and Research
Triet M. Tran, PhamD, 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. Dr. Tran 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
Audrey Vigil, Director of Investigations, 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. Ms. Vigil 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: Thursday
8:00–8:30 - Registration and Continental Breakfast
8:30-9:30 - FDA Conduct of Clinical Investigator Inspections
Samson Oluseye, PharmD, Investigator, BIMO Division II (West), Office of Regulatory Affairs (ORA), FDA
Dr. 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.
9:30-10:30 - IRB Regulations and FDA Inspections
Grace Santos, Supervisory Investigator, BIMO Division II (West), Office of Regulatory Affairs (ORA), FDA
During this session, Ms. Santos 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.
10:30-10:45 - Break (with opportunity for conversations and discussion)
10:45-11:45 - Informed Consent Regulations
Grace Santos, Supervisory Investigator, BIMO Division II (West), Office of Regulatory Affairs (ORA), FDA
Samson Oluseye, PharmD, 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.
11:45-12:30 - Part 11 Compliance—Electronic Records
Audrey Vigil, Director of Investigations, BIMO Division II (West), Office of Regulatory Affairs (ORA), FDA
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.
12:30 – 1:15 - Lunch (Provided)
1:15-2:00 - Decentralized Clinical Trials
Eric Pittman, MBA, Program Division Director, BIMO Division II (West), Office of Regulatory Affairs (ORA), FDA
Mr. Pittman 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
Eric Pittman, MBA, Program Division Director, BIMO Division II (West), Office of Regulatory Affairs (ORA), FDA
This presentation will cover Fiscal Year 2022 metrics and selected regulatory actions taken by the Agency.
3:30- 4:00 - Question and Answer Session / Panel Discussion