Agenda

Virtual FDA Conference: FDA Clinical Trial Requirements, Regulations, Compliance and GCP Conference


*All times are in Eastern Time Zone


Day 1


11:00 AM ET: FDA Welcome and Opening Comments

Anne Johnson, Program Director BIMO East, 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

Peter Lenahan, Consumer Safety Officer BIMO East, 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 PM ET: Working with FDA's Center for Biologics Evaluation and Research

LCDR Malcolm Nasirah, PharmD, MS, Consumer Safety 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. This session will consider the organization, mission, and activities of the Center as well as the Center’s inspection program.

1:30 PM ET: Q&A and Break

2:30 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.

Day 2


11:00 AM ET: What FDA Expects in a Pharmaceutical Clinical Trial

Ryan Raffaelli, MD, Medical 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.

12:00 PM ET: 21 CFR Part 11 Compliance

Zana Marks, MD, MPH, Medical Officer, 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.

1:00 PM ET: Q&A and Break

2:00 PM ET: Drugs/Devices/Biologics

Nicole Bell, Staff Director, BIMO, FDA
LCDR Bell with discuss the regulatory similarities and differences for drugs, devices, and biologics. The presentation compares and contrasts the regulations for drugs, devices, and biologics.

3:00 PM ET: COVID-19 Guidance Updates
Anne Johnson, Program Director BIMO East, FDA

Day 3


11:00 AM ET: Clinical Investigations

Peter Lenahan, Consumer Safety Officer BIMO East, 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 PM ET: Informed Consent

Marcia Worley, Consumer Safety Officer, FDA
This discussion considers regulations addressing the Informed Consent process and documentation from the investigator’s point of view.

1:00 PM ET: Q&A and Break

 2:00 PM ET: BIMO Compliance and Enforcement

Anne Johnson, Program Director BIMO East, FDA
This presentation will cover Fiscal Year 2019 metrics and selected regulatory actions taken by the Agency.