Risk-based principles and quality management systems are the new reality of clinical auditing. Building on their foundation of traditional auditing techniques, auditors must now expand and adapt their skills to be effective in this new environment. CHI’s fifth annual Clinical Auditing Forum is designed to help auditors meet these challenges head on, with the goal of strengthening auditing programs and ensuring compliance with risk-based techniques.
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Tuesday, June 2
12:00 pm Conference Registration
1:15 Welcome & Chairperson’s Opening Remarks
1:20 Implementing Risk-Based Auditing
Dirk Gille, Vice President, Head Bioresearch QA, Janssen R&D, Belgium
To ensure patients in high medical need continue to have access to affordable drugs, companies and authorities are looking at means to decrease the cost of clinical trials while still maintaining oversight on patient safety and integrity, and data credibility. A risk-based approach has been encouraged by both EMA and FDA as a means to deploy resources where it matters most based on identified risks. Auditing is an important tool to get detailed insight in the quality and compliance of clinical development and more specifically the execution of clinical trials. This presentation will provide insight on a proposal on how risk-based auditing can be implemented in an organization by deploying a risk management framework, performing a formal risk assessment on the trial, and translating the identified risks and related controls into the audit diagnostic tool, used by the auditor.
1:55 Risk Management: An ICH Perspective
Bob Figarotta, Senior Manager, Clinical, Allergan
ICH Q9 principles outline quality risk management methodologies that can be applied to all types of audit programs. This includes tools to assist in discovering where audit programs should focus their attention and resources, and what to do with risks identified during the planning and execution of the audit program. This presentation will encompass discussion of the following areas of risk management with an ICH Q9 perspective:
• Potential Applications
• Quality Risk Management Process
• Assessments and Controls
• Methods and Tools
2:30 Sponsored Presentation (Opportunity Available)
3:00 Networking Refreshment Break and Exhibit Viewing
3:30 Rethinking CAPA Metrics and TMF Metrics: Are You Measuring the Right Things?
Linda B. Sullivan, Co-Founder & President, Metrics Champion Consortium (MCC)
The Metrics Champion Consortium (MCC) has done extensive research into the standardization of metrics that drive clinical trial quality. In this session, your speaker will address:
• How what you measure influences people’s behavior
• How adopting performance metrics supports clinical trial planning
• How the right metrics can support your QMS knowledge management program
4:05 Case Study: Building an Effective CAPA Management Process
Federico Feldstein, J.D., Vice President, Medical Regulatory Compliance, Pfizer, Inc.
This presentation will provide an overview on quality issues and the execution of a CAPA, with a focus on building an effective CAPA management process. Topics will include:
• Developing a compliant, effective, and efficient CAPA System
• Conducting a robust, systematic investigation and effectively measuring performance
• Examining quality issues to determine severity, occurrence, and level of impact (systemic vs. non-systemic issues) to prioritize management and remediation
• Addressing systemic issues at multiple sites, executing a CAPA, and overseeing CAPA execution
• Case Study: Reinforce your understanding of CAPA management and execution by applying best practices to manage a systemic quality issue
4:40 Risk-Based Monitoring and Quality Management Systems
Denise M. Shelley, MS, Clinical Project Manager II, Clinical Research Directorate, Clinical Monitoring Research Program (CMRP), Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research
This presentation includes an analysis of the data collected from monitoring visits in support of the National Institute of Allergies and Infectious Disease (NIAID) intramural domestic and international clinical research program demonstrating how risk based monitoring (RBM) plans are developed and used to support implementing quality systems. This presentation will demonstrate how a RBM plan is developed based on site findings and in turn used to provide guidance to assist site staff in developing their quality systems plans. An analysis of monitoring visit findings of NIAID funded intramural clinical trials has shown higher frequencies in the areas of protocol procedure compliance, the informed consent/process and subject eligibility. These are similar to the findings noted by the FDA Office of Scientific Investigations as reported in their January 2014 annual inspection metrics report. (Funded by NCI Contract No. HHSN261200800001E. This research was supported [in part] by the National Institute of Allergy and Infectious Disease.)
5:15 Reception and Exhibit Viewing (Sponsorship Opportunity Available)
5:45 Short Course Registration
6:00 Close of Day One
Wednesday, June 3
7:15 am Breakfast Presentation (Sponsorship Opportunity Available)
or Morning Coffee
8:00 Chairperson’s Opening Remarks
8:10 Avoiding the Leap from 483 to Warning Letter
Robert Romanchuk, BSHS, CCRC, CIP, CHRC, Vice Chair, Schulman Associates, IRB
All too often, sites move on after responding to a 483 only to receive a Warning Letter a few months later. A series of sponsor, IRB, and FDA audits ensue, with business consequences that can be tragic. In worst case scenarios, a good site is taken down simply because they did not respond to a 483 adequately. (Un)fortunately, the records of these events are public and can be consulted by those wishing to avoid this chain of events. This presentation will analyze recent 483s and Warning Letters, examine guidance, and extrapolate best practices to avoid the leap from 483 to WL. Your presenter will share practical experiences from his nine years of investigator site audits on behalf of independent IRBs.
8:45 Sponsor Oversight: The Importance of Auditing in Vendor Management
Beverly Brown, Manager, Global Regulatory Quality, Allergan
9:20 Sponsored Presentation (Opportunity Available)
9:35 Networking Coffee Break and Exhibit Viewing
10:20 Case Study: Achieving Compliance in Human Subject Research: Elements of Compliance Structures and Quality Systems
Johanna L. Stamates, RN, MA, CCRC, CHRC, Executive Director, RCQA (Research Compliance and Quality Assurance), University of Miami
The field of clinical research is constantly evolving. The ever-changing regulations, rules and guidance documents, increased oversight by regulatory agencies, and the increasing sophistication of the public and of potential research subjects require not only sponsors, but also universities and academic medical centers to stop and reflect on their current practices in the conduct of clinical research. The current climate requires awareness, implementation of a robust compliance structure, use of quality systems, and risk management approaches. In short, a proactive rather than a reactive approach. This presentation will provide the audience with examples of positive changes, heightened awareness, and strategies for the implementation of new and strengthening of existing compliance structures and quality systems. Essential elements for a robust organizational compliance structure and examples of potential/existing barriers in the compliance “culture” will be presented. Attendees will be introduced to existing quality systems at the University as well as those in the planning and implementation stage. The take-home message is that compliance professionals must be viewed as change agents rather than clinical research police.
11:00 Interactive Roundtable Discussions
11:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:00 pm Decrease Audit Traffic and Increase Audit Value through Broader Audit Scope and Exchange of Information
Dr. Barbara Heumann, Managing Director, GXP-Engaged Auditing Services GmbH
Debra Ploss, Quality Manager, GXP-Engaged Auditing Services GmbH
The sharing of information obtained during audits continues to be a difficult concept in the world of clinical research, although the advantages of this are increasingly apparent. Through exchange of basic information obtained in previous audits, the number of audits conducted at any one facility could be reduced, and the scope of information covered in each audit conducted could be broadened. Instead of covering just the basics of one study, the performance of the site or vendor could be evaluated over several studies, the participation of individual patients in various studies could be followed, and the remediation of issues discovered in previous audits could be followed up. This would give a more transparent and more complete picture of the overall compliance of the facility, aiding in the future selection of appropriate sites/vendors.
1:35 Risk-Based Audit Planning: Developing a Three Year Strategy
Rita Farrell, Compliance Specialist, Global Quality & Regulatory Compliance – Clinical Trials & Safety (GQRC-CT&S), Bristo-Myers Squibb
This session will address the strategy and risk management techniques applied to planning Good Clinical Practice (GCP) audits from both a short and long term perspective. The presentation will include a review of the planning for three audit types: investigator site audits, vendor audits, and internal system audits (including safety related audits). In addition, it will outline the process of obtaining stakeholder input and management endorsement, including the guidelines utilized to obtain data, calculations used to analyze the data, and the resulting documentation.
2:10 Sponsored Presentation (Opportunity Available)
2:25 Networking Refreshment Break
2:40 Randomized Controlled Trials: Ethics, Consenting, Maintaining the Blind, and Protocol Adherence
Jerri B. Perkins, M.D., former Medical Officer, FDA
Currently (NEJM Dec 18, 2014) FDA is making the case for RCTs (Randomized Controlled Trials) in evaluating Ebola therapies. FDA is challenging industry and the medical community in the necessity of conducting scientifically valid trials and understanding the importance of the placebo effect. This session will include an overview by a former FDA medical officer on the importance of learning how to think like a regulator especially during the consenting process, maintaining the blind and protocol adherence. This presentation will use case studies to demonstrate the power of RCTs to achieve success. Bring your questions and join the discussion as we learn to see through the eyes of a regulator. Upon completion of this program participants will be able to better prepare investigators and site for current study design challenges to fulfill both ethical and regulatory requirements.
3:15 Managing Global Inspections
Janis A. Little, MS, Vice President, Global Regulatory Quality, Allergan
3:50 pm Close of Summit
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