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8:00 – 8:30 am |
Registration & Continental Breakfast |
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8:30 – 9:15 am |
Welcome & Opening Comments Jessica Rowe, MA, MS, CCRP, CIP, Yale Cancer Center Mishelle L. Harriger, Acting Division Director, BIMO Division 1 (Northeast) Office of Inspections and Investigations (Oll), FDA Ms. Harriger will address the mission of FDA and the role of the Office of Bioresearch Monitoring Inspectorate (OBMI) relative to the Bioresearch Monitoring Program. |
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9:15 – 10:45 am |
Knock Knock- The FDA Inspection Process D'Arbra Blankenship and Gabrielle Swain, Investigators, BIMO Division 1, Office of Inspections and Investigations, 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.' |
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10:45 – 11:00 am |
Break |
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11:00 – 12:30 pm |
Regulatory Requirements: Clinical Investigator's Responsibilities and the Clinical Research Pharmacist's Role Kathryn Suttling, Investigator, BIMO Specialist, BIMO Division 1, Office of Inspections and Investigations, FDA This presentation will cover clinical investigator regulatory obligations and the clinical research pharmacist's role in compliance, focusing on the five most commonly cited regulations in FDA Form 483s. Ms. Suttling will share strategic questions designed to foster best practices that strengthen patient safety and improve data quality. |
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12:30 – 1:30 pm |
Lunch |
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1:30 – 2:30 pm |
Building Quality into the System Matthew Watson, Investigator, BIMO Specialist, BIMO Division 1, Office of Inspections and Investigations, 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. Mr. Watson 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. |
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2:30 – 3:15 pm
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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. |
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3:15 – 3:30 pm |
Break |
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3:30 – 4:30 pm |
Quality by Design D'Arbra Blankenship and Gabrielle Swain, Investigators BIMO Division 1, Office of Inspections and Investigations, FDA Ms. Swain will discuss the principles of Quality by Design, as described in ICH E8(R1) General Considerations for Clinical Studies, and in the FDA’s draft ICH E6(R3) Good Clinical Practice guideline. Case study will demonstrate how applying good design principles can contribute to both improved trial design and tailored trial oversight. |
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4:30 – 5:00 pm |
Q&A/Panel Discussion |
Day Two: Thursday
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8:00 – 8:30 am |
Registration & Continental Breakfast |
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8:30 – 9:30 am |
FDA Conduct of Clinical Investigator Inspections Meredith Miller and Matthew Watson, Investigators, BIMO Division 1, Office of Inspections and Investigations, FDA The investigators 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. |
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9:30 - 10:30 am |
IRB Regulations and FDA Inspections Kathryn Suttling, Investigator, BIMO Specialist, BIMO Division 1, Office of Inspections and Investigations, FDA Ms. Suttling 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. |
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10:30 - 10:45 pm |
Break |
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10:45 – 11:45 pm |
Informed Consent Regulations Meredith Miller, Investigator, BIMO Division 1, Office of Inspections and Investigations, FDA Ms. Miller will discuss regulations addressing the Informed Consent process and documentation from the investigator’s point of view. |
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11:45 - 12:30 |
Improving Informed Consent - Informed Consent Draft Guidance Gabrielle Swain, Investigator BIMO Division 1, Office of Inspections and Investigations, FDA Ms. Swain will discuss the 2024 FDA draft guidance: Key Information and Facilitating Understanding in Informed Consent. |
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12:30 – 1:15 pm |
Lunch |
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1:15 - 2:00 pm
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Decentralized Clinical Trials Matthew Watson, Investigator, BIMO Specialist BIMO Division 1, Office of Inspections and Investigations, FDA Mr. Watson 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. |
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2:00 - 2:30 pm |
Break |
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2:30 – 3:30 pm |
BIMO Compliance and Enforcement Mishelle Harriger, Acting Division Director, BIMO Division 1, Office of Inspections, Investigations, FDA Ms. Harriger will cover Fiscal Year 2024 metrics and selected regulatory actions taken by the Agency. |
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3:30 - 4:00 |
Q&A / Panel Discussion |