8:00–8:30 - Registration and Continental Breakfast
8:30–8:45 - SOCRA Welcome
8:45–9:15 - FDA Welcome and Opening Comments
Christine M. Smith, Division Director, BIMO Division 2 (Southeast), Office of Inspections and Investigations (OII), FDA
Ms. Smith will address the mission of FDA and the role of the Office of Bioresearch Monitoring Inspectorate (OBMI) relative to the Bioresearch Monitoring Program.
9:15–10:45 - Knock Knock - The FDA Inspection
Christine M. Smith, Division Director, BIMO Division 2 (Southeast), Office of Inspections and Investigations (OII), 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’.
10:45–11:00 - Break (with opportunity for conversations and discussion)
11:00–12:30 - 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, Senior Pharmacologist, 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)
1:30–2:15 - 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.
2:15-3:15 Building Quality into the System
LauraLee Staples, Branch Chief, BIMO Division 2 (Southeast), Office of Inspections and Investigations (OII), 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. Staples will focus on 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.
3:15-4:30- Quality by Design
Ann Meeker-O’Connell, Director, Office of Clinical Policy and Programs (OCLiP), Office of the Commissioner, FDA
This session will provide a hands-on opportunity to apply the principles of Quality by Design, as described in ICH E8(R1) General Considerations for Clinical Studies, and in the draft ICH E6(R3) Good Clinical Practice guideline. Participants will discuss how applying good design principles can contribute to both improved trial design and tailored trial oversight.
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
LT Koffi Amegadje, PharmD, Investigator, BIMO Division 2 (Southeast), Office of Inspections and Investigations (OII), FDA
Dr. Amegadje 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
LauraLee Staples, Branch Chief, BIMO Division 2 (Southeast), Office of Inspections and Investigations (OII), FDA
Ms. Staples 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
LT Koffi Amegadje, PharmD, Investigator, BIMO Division 2 (Southeast), Office of Inspections and Investigations (OII), FDA
Dr. Amegadje will discuss regulations addressing the Informed Consent process and documentation from the investigator’s point of view.
11:45-12:30 – Informed Consent- Guidance and Best Practices
Ann Meeker-O’Connell, Director, Office of Clinical Policy and Programs (OCLiP), Office of the Commissioner, FDA
Ms. Meeker-O’Connell will discuss recent FDA draft guidance on key information in informed consent and other related agency activities.
12:30 – 1:15 - Lunch (Provided)
1:15-2:00 - Decentralized Clinical Trials
LauraLee Staples, Branch Chief, BIMO Division 2 (Southeast), Office of Inspections and Investigations (OII), FDA
Ms. Staples 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
Christine M. Smith, Division Director, BIMO Division 2 (Southeast), Office of Inspections and Investigations (OII), FDA
Ms. Smith will cover Fiscal Year 2023 metrics and selected regulatory actions taken by the Agency.
3:30- 4:00 - Question and Answer Session / Panel Discussion