Thursday, June 16, 2011
7:15 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
8:00 Research Compliance Assessment at the University of Miami
Johanna L. Stamates, RN, MA, CCRC, Director, Office of Research Compliance Assessment, University of Miami
This presentation will provide an overview of the research compliance program at the University of Miami. The Office of Research Compliance Assessment (ORCA) is independent from the Institutional Review Board (IRB) and reports directly to the University Vice Provost for Research. ORCA conducts Good Clinical Practice (GCP) and social-behavioral audits at all University of Miami (UM) campuses and research sites, including directed, routine, focused, and investigator requested audits. ORCA audits and Principal Investigator responses are forwarded to the IRB, the Vice Provost for Research, and the respective Dean. Additionally, ORCA provides educational classes and seminars to the UM research community, covering a broad variety of research-related topics. This presentation will include the selection of audits, the audit process, the audit reporting structure, and corrective and preventive action.
8:45 Beyond the Research Department: Analyzing Practices Across an Adult Oncology Practice for Global Compliance Improvement
Susan Radtke, RN, MA, CCRP, Quality Analyst, Norton Cancer Institute
Investigator sites, monitors, and sponsors all have been challenged since the publication of the 2009 Guidance “Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects.” This document served to further clarify and define policies which have existed in research for years but loosely interpreted. As an adult oncology practice operating within a hospital corporation serving up to seven geographic sites, we have been analyzing and redefining processes in order achieve greater compliance with this guidance. This analysis included both the research program as well as overall clinical operations, with a focus on collaborative processes, quality improvement initiatives, and education. This discussion will focus on the workflow involved in this initiative:
Systems review and department mapping
Personnel review, orientation, and education needs
Change process
9:30 Networking Coffee Break and Exhibit Viewing
9:50 Preparation of Sponsor, Monitor, and Investigative Sites for Regulatory Inspections
Swati Tendolkar, Program Manager, Global System Quality Assurance, Johnson & Johnson
Omega Norton-Crable, Associate Director, Therapeutic Area Quality Assurance, Johnson & Johnson
The session will provide information and checklists regarding inspection readiness pertinent to the FDA Investigator Site and Sponsor-Monitor Inspections. In the present regulatory environment with heightened regulatory surveillance, it is essential to understand the FDA inspection process and be prepared for an inspection. The audience will gain knowledge regarding the following:
Information pertinent to the FDA Investigator Site and Sponsor-Monitor Inspection processes such as selection, conduct, and communication of the inspectional findings
Preparation activities such as planning meetings to discuss the inspection logistics, developing inspection roles and responsibilities list, retrieving and reviewing key study documents
Inspection activities such as greeting the FDA investigator(s), inspection room activities, responding to the FDA requests, inspection feedback, and conclusion
Post Inspection Activities such as reviewing the inspection findings, developing effective corrective and prevention plans, and responding to the FDA Inspection Findings
10:35 Investigative Site Compliance: Performing Strategic Clinical Investigator Site Audits
Elizabeth Ronk Nelson, MPH, President and Senior Consultant, Regulatory Risk Management, LLC
ICH defines audits as planned and established systematic examinations of trial-related processes and documentation to determine global compliance. An audit is an opportunity to prospectively evaluate the systems that drive those processes and generate the data and documentation to be assessed. The sponsor’s development of robust auditing and monitoring plans and incorporation of protocol implementation planning at the site permits a review of the systems that are required to ensure credible data is obtained from protected subjects, regardless of therapeutic area or investigational product being studied. This presentation will utilize the synthesis of regulatory documents and case studies to support a proposed framework of systems with procedures that assure the quality of every aspect of the trial is addressed while proactively assessing regulatory risk.
11:20 Managing Internal & External Audits: How to Optimize Logistics and Use Technology to Improve the Audit Experience
BJ Guthrie, Manager, Clinical Operations, Clinical Research, Abbott Vascular
This session is designed to give the audience a very practical overview of how some large clinical research organizations manage internal and external (regulatory authority) audits. This session will include information on the following audit-related topics: audit planning and preparation; audit logistics; and the tools and technology available to help increase audit efficiency and improve the overall audit experience. This session includes very practical information that can be implemented and used successfully regardless of the size of the clinical organization. The audience will gain a better understanding of how to adequately plan for audits, how to manage the logistics of the audit, and how to use technology (web-conferencing, instant messaging, and clinical trial management systems) effectively during audits. This will help increase the overall audit experience and increase the efficiency of the audit.
12:05 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:20 Meeting the Challenges in Delivering Quality Global Clinical Data Karine Julien, M.Sc., M.B.A., Disease Area Lead, Cardiovascular, Pfizer Medical Quality Assurance
Federico Feldstein, J.D., Senior Director, Head of Primary & Consumer Healthcare BU Quality Assurance, Pfizer Medical
The pharmaceutical industry is constantly facing challenges in delivering quality clinical trial data such as the globalization of clinical trials, an intensified regulatory scrutiny, and the increased complexities in clinical trial design and conduct. Sponsors need to adapt and ensure that a robust quality oversight program can overcome these challenges not only in the end product of clinical trials, but also by designing in quality up-front through integrated quality management systems. This presentation will discuss some of the challenges that the industry is facing in the development and conduct of clinical trials, as well as various quality strategies that could be considered to ensure quality oversight of clinical trials.
2:05 Auditing Clinical eSource Records
Chris Wubbolt, Senior Director, Compliance Services, Compliance Services, Accuex, Inc.
This session will discuss considerations for auditing electronic source records at clinical sites. Requirements for electronic source record controls will be reviewed based upon FDA and industry guidance. After review of electronic source record requirements, examples of eSource records as well as issues that may occur with regard to the control and integrity of source records will be reviewed. Auditing practices, including example checklists and questions, will be provided during the presentation. After review of eSource recordkeeping requirements, review of examples, and distribution of the auditing checklists, example case studies will be reviewed and discussed with the audience. At the conclusion of the presentation, the audience will have an understanding of eSource recordkeeping requirements, areas of concern when electronic source records are maintained at clinical sites, and a strong understanding of audit requirements and questions to ask when assessing a site’s eSource record controls.
2:50 Networking Coffee Break and Exhibit Viewing
3:10 Vendor Audits from a Sponsor’s Perspective
Jennifer Leonard, Program Manager, Global System Quality Assurance, Johnson & Johnson
Rather than the “dog and pony show” of a vendor assessment, the sponsor’s process of auditing vendors should involve auditing of actual data whenever possible. In this session, we will discuss the various types of vendors that might be audited, including examples of standard and niche providers. We will also explore the question of whether the auditors themselves have the expertise needed to conduct the audit. We will discuss inspection readiness, including examples of how to prepare a vendor for a possible Health Authority (HA) inspection, how HAs ask sponsors questions about vendors, and sponsor oversight of the process. We will explore risk assessment, including risk-based approaches, determining which vendors to audit, and determining how often to audit. Audit reports, corrective action management, and follow-up will be discussed, including tips on managing vendor willingness to accept recommendations for improvement. Audit logistics, preparation, conduct, and reporting will be reviewed in detail.
3:55 Conducting Compliant Clinical Research: A Canadian Perspective
Hope Senechal, B.Sc., CCRA, Clinical Research Auditor, Administration, Ottawa Hospital Research Institute
As we are just a hop, skip, and a jump away, it’s easy to assume that conducting clinical research in Canada is equivalent to conducting clinical research in the United States. However, Canada does have a few unique differences. Using Health Canada inspection findings and common audit observations, this session will illustrate a few of these key differences and provide suggestions to overcome challenges in conducting clinical research in Canada. By the end of the session participants will be able to:
Identify the regulations which pertain to research in Canada
Describe common examples of noncompliance noted by both Health Canada’s GCP inspectorate and internal QA programs
Identify strategies to overcome the challenges in conducting compliant clinical research in Canada
4:40 Preparation for European Regulatory Agency GCP Inspections
Steve Keys, Head of Quality, The Clinical Trial Company Ltd.
Clinical Trials are often global and need to pass both FDA and European Regulatory inspection. Europe has had statutory GCP inspections since 2004 for sites, CROs, and Sponsors involved in Clinical Trials. The European and US approaches to GCP inspections differ in many respects. This presentation looks at the approach of European member state inspections and the pre-approval GCP inspections carried out by the EMA. The preparation for and format of EU inspections, their findings, and implications on drug approval in Europe will be presented. The differences between the EU approach and that of the FDA sometimes result in a trial being acceptable for registration in North America but not within the European community. The audience will gain insight into the format of EU statutory GCP inspections and EMA pre-approval GCP inspections. Information will be presented on what type of inspections are carried out by European agencies in North America, their findings, and what can be learned from these experiences.
5:25 Close of Conference
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