Event Calendar

Agenda

FDA Clinical Trial Requirements Regulations, Compliance and GCP Conference


November 13 and 14, 2019 |  Philadelphia, PA - Jointly Sponsored with the FDA Philadelphia Office

For a printable PDF of the November 2019 agenda, click here.

Day One- Wednesday
Glenn Bass, District Director, Detroit District, FDA
The speaker will address the role of the FDA District Office relative to the Bioresearch Monitoring Program.
8:45 – 9:45   Modernizing FDA’s Clinical Trials / BIMO Programs
Janet Donnelly, BA, CIP, RAC, Policy Analyst, Good Clinical Practice Program, Office of GCP, Office of the Commissioner, FDA
This presentation will provide an overview of the good clinical practice program through a discussion of achievements in the regulation of FDA regulated clinical trials, the challenges facing Clinical Investigators, Sponsors, and IRBs in clinical research, and the various initiatives underway within FDA.
9:45 - 10:15        Break (with opportunity for conversation and discussion)
10:15 - 11:30  What FDA Expects in a Pharmaceutical Clinical Trial
Susan Leibenhaut, MD, Medical Officer; Division 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. This presentation 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.
11:30 –  12:30 Medical Device Aspects of Clinical Research 
Irfan Khan, Consumer Safety Officer, Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health, FDA
Mr. Khan 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.  
12:30 – 1:30 Lunch (Provided)
1:30 - 2:30 Adverse Event Reporting – Science, Regulation, Error and Safety
John Kessler, PharmD, Founder and Chief Clinical Officer of SecondStory Health;
Clinical Associate Professor, University of North Carolina School of Pharmacy
Chairman of the Duke University Health System Institutional Review Board
The science, regulation and assessment of adverse events will be discussed in a context that brings forth the motivations and ethics of human research protections.  The role of system errors and safe medication practices will be discussed.
2:30-3:30 Working with FDA’s Center for Biologics Evaluation and Research
Patricia Holobaugh, MS, Branch Chief, 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.
3:30- 3:45 Break (with opportunity for conversation and discussion) 
3:45 - 4:30   Ethical Issues in Subject Enrollment
Joal Hill, JD, MPH, PhD, Director, Research Ethics; 
Chairman, Institutional Review Board, Advocate Health Care
As applied to human subject studies, the ethical principle of justice underlies responsible participant selection requiring fair distribution in the burdens and benefits of research.  Although some groups have been specifically identified in federal regulations as particularly vulnerable to exploitation in research, subjects who are not members of those groups may also require special consideration because of cognitive, medical, or other deficits.  This session will address how the current research climate (e.g., increased industry investment in research, online research, etc.) affects the ethics of subject enrollment and will suggest ways of recognizing and safeguarding susceptibilities of research subjects. 
4:30 - 5:00   Question and Answer Session / Panel Discussion

8:00–8:30 - Registration and Continental Breakfast

8:30–8:45 - SOCRA Welcome

8:45–9:15 - 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.

9:15–9:30 - Break (with opportunity for conversations and discussion)

9:30–10:45 - Knock Knock - The FDA Inspection
Christine Smith, BS, Director of Investigations, 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’.

10:45–11:30 - Medical Device Aspects of Clinical Research
Marisa White, Lead Consumer Safety Officer, Center for Devices and Radiological Health, FDA
Ms. White 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.

11:30–12:30 - What FDA Expects in a Pharmaceutical Clinical Trial

Aisha Johnson, 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. Dr. Johnson 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.

12:30–1:30 - Lunch (Provided)

1:30–2:30 - Adverse Event Reporting – Science, Regulation, Error and Safety
John Kessler, PharmD, Founder and Chief Clinical Officer of SecondStory Health; Clinical Associate Professor, University of North Carolina School of Pharmacy
The science, regulation and assessment of adverse events will be discussed in a context that brings forth the motivations and ethics of human research protections.  The role of system errors and safe medication practices will be discussed. 

2:30–3:15 - Ethical Issues in Subject Enrollment
Joal Hill, JD, MPH, PhD, Director, Research Ethics; Chairman, Institutional Review Board, Advocate Health Care

As applied to human subject studies, the ethical principle of justice underlies responsible participant selection requiring fair distribution in the burdens and benefits of research.  Although some groups have been specifically identified in federal regulations as particularly vulnerable to exploitation in research, subjects who are not members of those groups may also require special consideration because of cognitive, medical, or other deficits.  Dr. Hill will address how the current research climate (e.g., increased industry investment in research, online research, etc.) affects the ethics of subject enrollment and will suggest ways of recognizing and safeguarding susceptibilities of research subjects.

 3:15–3:30 - Break

3:30–4:30 Working with FDA’s Center for Biologics Evaluation and Research
Christine Drabick, 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 marketingof biologic drug products. This session will consider the organization, mission, and activities of the Center as well as the Center’s inspection program.

4:30–5:00 - Question and Answer Session / Panel Discussion


Day Two- Thursday

8:00–8:30 - Registration and Continental Breakfast

8:30-9:15 - FDA Conduct of Clinical Investigator Inspections

CDR Michael Serrano, Bioresearch Monitoring Specialist, BIMO East, FDA
CDR Serrano 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.

9:15-10:00 - Investigator Initiated Research

George D’Addamio, PhD, President, PharmConsult, Inc.
The Sponsor/Investigator takes on numerous additional responsibilities including protocol development, assurance of peer review, development and quality assurance related to Data Capture Procedures. They must secure financial and clinical resources, and they have the opportunity for Publication. All of these activities fall under the regulations and are subject to FDA oversight. This session will offer details about the Sponsor/Investigator’s legal responsibilities and insight into the additional activities the Sponsor/Investigator must provide.

10:00-10:15 - Break (with opportunity for conversations and discussion)

10:15-11:00 - Meetings with the FDA—Why, When and How

Celia Peacock, Project Management, Center for Drug Evaluation and Research, FDA
It is of the utmost importance to the research project to assure good communication and timely interactions with the FDA. This speaker will discuss the various types of meetings available to the sponsors/investigators to enhance the communication process with the FDA and offer some practical tips that can greatly facilitate the review process.

11:00 – 12:00 - Part 11 Compliance—Electronic Records

Rachel Skeete, MD, Team Leader, 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.

12:00 – 1:00 - Lunch (Provided)

1:00-2:00 - IRB Regulations and FDA Inspections

LCDR Iram R. Hassan, Ph.D., Bioresearch Monitoring Specialist, BIMO East, FDA
During this session, LCDR Hassan 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.

2:00 – 2:30- Break (with opportunity for conversation and discussion)

2:30 – 3:30 - Informed Consent Regulations
CDR Peter Lenahan, DC, MPH, PhD, Investigator, BIMO East, FDA
This discussion considers regulations addressing the Informed Consent process and documentation from the investigator’s point of view.

3:30- 4:15 - BIMO Compliance and Enforcement
Anne Johnson, Program Division Director, BIMO East, FDA
This presentation will cover Fiscal Year 2018 metrics and selected regulatory actions taken by the Agency.

4:15–4:35 - Question and Answer Session / Panel Discussion