*All times are in Eastern Time Zone
11:00 AM ET: FDA Welcome and Opening Comments
Anne Johnson, District Director, Philadelphia Office (PA/DE), Program Division Director, BIMO Division I (East), 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
Donna Gallien, Investigator, 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’.
12:30-12:40 PM Break and Q&A
12:40 - 1:40 PM ET: What FDA Expects in a Pharmaceutical Clinical Trial
LCDR Quynh-Van Tran, MD, Regulatory Review Officer, 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. The speaker 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.
1:40 - 2:10 Break and Q&A
2:10 PM ET: E-Systems in Clinical Trials – A Regulatory Perspective
Cheryl Grandinetti, PharmD, Pharmacologist, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, 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.
11:00 AM ET: Building Quality into the System
LCDR Dustin Abaonza, PharmD, Investigator, 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: Medical Device Aspects of Clinical Research
Cynthia Bushee, BSN, Consumer Safety Officer, Center for Devices and Radiological Health, FDA
The speaker 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.
1:10 - 1:40 PM ET: Q&A and Break
1:40 PM ET: Sponsor Oversight of Decentralized Clinical Trials
Dr. Debra Boyd-Seale, PhD, Consumer Safety Officer, BIMO Division II (West), Office of Regulatory Affairs (ORA), FDA
Ms. Johnson 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. Dr. Boyd-Seale will discuss the Sponsor’s oversight of DCTs and key issues to consider.
2:40 PM ET: COVID-19 Guidance Updates
Stephanie Mangigian, MS/OSH, BSN, ASN, BIMO Specialist, BIMO Division I (East), Office of Regulatory Affairs (ORA), FDA
11:00 AM ET: Clinical Investigations
LCDR Richard Lyght, Consumer Safety Officer, FDA
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
Shirley Wen, Consumer Safety Officer, BIMO Division I (East), Office of Regulatory Affairs (ORA), FDA
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: BIMO Compliance and Enforcement
Laura Lee Staples, BA, Certified BIMO Specialist, Consumer Safety Officer, BIMO Division I (East), Office of Regulatory Affairs (ORA), FDA
This presentation will cover Fiscal Year 2020 metrics and selected regulatory actions taken by the Agency.