Day 1: Tuesday, May 12th
11:00 AM ET: FDA Welcome and Opening Comments, Eric Pittman, Program Director BIMO West, FDA
Mr. Pittman 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, Program Director BIMO West, 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, 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.
3:00 PM ET: Medical Device Aspects of Clinical Research, Cynthia Bushee, BSN, Consumer Safety Officer, FDA
Ms. Bushee 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: Wednesday, May 13th
11:00 AM ET: Introduction to Investigational New Drugs, Lara Akinsanya, Science Policy Analyst, Center for Drug Evaluation and Research, FDA
Ms. Akinsanya will introduce the IND Process and Clinical Trial Regulations, discuss how to determine if an IND is needed for a clinical trial, summarize the types of INDs, and share information on the Pre-IND Consultation process at the FDA.
12:30 PM ET: 21 CFR Part 11 Compliance, Cheryl Grandinetti, 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.
3:00 PM ET: What FDA Expects in a Pharmaceutical Clinical Trial, Rachel Skeete, MD, Team Leader, 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. Dr. Skeete 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.
Day 3: Thursday, May 14th
11:00 AM ET: COVID-19 Guidance Updates, Iris MacInnes, Consumer Safety Officer, FDA
12:30 PM ET: Clinical Investigations, Dawn Olenjack, BS, DC, Consumer Safety Officer, FDA
Ms. Olenjack 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.
3:00 PM ET: Informed Consent, Travis Beard, Consumer Safety Officer, FDA
This discussion considers regulations addressing the Informed Consent process and documentation from the investigator’s point of view.