*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’.
12:45-12:55 PM Beak and Q&A
12:55 - 2:00 PM ET: 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.
2:00 - 2:10 Break and Q&A
2:10 PM ET: CDRH (Looking for them to present on the application review up to the assignment of an inspection to BIMO) 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.
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: 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.
1:10 - 1:40 PM ET: Q&A and Break
1:40 PM ET: Investigational Review Boards
Dina Tallman, Investigator, BIMO-W
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: Clinical Investigations
Chelsea Lamm, Investigator, BIMO-W
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
Dina Tallman, Investigator, BIMO-W
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
Eric Pittman, MBA, Program Division Director, BIMO Division II (West), Office of Regulatory Affairs (ORA), 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 presenter will discuss the Sponsor’s oversight of DCTs and key issues to consider.