7th Annual

Clinical Trial Auditing

Building Effective Audit Programs

April 24-25, 2017

The goal of a clinical trial audit is to ensure that patient safety is observed, that collected data is accurate, and that the conduct of the trial is compliant; to accomplish these tasks, a comprehensive quality management system and risk-based audit plan must be established. Cambridge Healthtech Institute’s Seventh Annual “Clinical Trial Auditing” conference will examine best practices and case studies for developing risk-based auditing practices, establishing CAPA plans, and creating effective audit teams.

Monday, April 24

7:25 am Conference Registration and Morning Coffee

SETTING THE STAGE FOR A SUCCESSFUL AUDIT

8:25 Chairperson’s Opening Remarks

Johanna L. Stamates, RN, MA, CCRC, CHRC, Executive Director, RCQA (Research Compliance and Quality Assurance), University of Miami

8:30 Setting the Stage for a Successful Audit: Building Effective Partnerships with Internal/External Stakeholders

Mark Lepkowski, GCP Audit Lead, R&D Audit and Inspection, Alexion Pharmaceuticals Inc.

This talk will address understanding your stakeholder landscape, educating others about the audit process, and involving stakeholders in the audit planning process. Discuss setting stakeholder expectations before an audit and learn tips to conducting a “no surprise” audit from the opening meeting to the debrief and getting the distribution list for the audit report right.

RISK-BASED APPROACH TO AUDITING

9:00 Assessing Sites’ Electronic Health Records for Clinical Research Readiness

Linda Maziarz, Director, Clinical Development QA, America’s Region, CDQA, GlaxoSmithKline

The importance of assessing sites’ Electronic Health Record (EHR) systems when used as a source in clinical trials is reflected in recent guidance issued by the FDA in the Draft Guidance on the Use of EHR Data and the MHRA Position Statement and Guidance on EHRs. There are many practical challenges for sponsors in how to go about assessing these systems to ensure they adhere to the fundamental elements of data quality (ALCOA). This session will highlight some of the challenges and offer suggestions to support sponsors in the assessment of EHR systems.

9:30 Evolution of an Internal Audit Program

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 rules, regulations, and guidance documents, increased protocol complexity, and evolution of the researchers themselves require continuing review of our audit programs, as well as solicitation of feedback from related compliance programs. This presentation will provide the audience with examples of strategies for review of an existing auditing program, as well as a step-by-step approach to the review of existing structures and of the implementation of new practices. Vision, focus on methodology and an open mind form the basis for successful implementation.

10:00 Networking Coffee Break

10:30 PANEL DISCUSSION: Developing a Risk-Based Auditing Plan for Modern Clinical Trials

Moderator:
Anthony Borisow, Senior Quality Manager, Clinical Quality Assurance, Vertex Pharmaceuticals Inc.

Panelists:
Ana Sharma, Global Head, Strategy and Operations, Clinical Development Quality, Novartis

Linda Maziarz, Director, Clinical Development Quality Assurance, America’s, GSK

Mark Lepkowski, GCP Audit Lead, R&D Audit and Inspection, Alexion Pharmaceuticals Inc.

Conventional auditing approaches are no longer efficient: as evolving regulations, complex clinical trial structures and outsourcing strategies, and new tools and technologies for data capture morph the face of clinical trials, a more risk-based approach to auditing is necessary. This panel will discuss best practices and methods for developing a risk-based audit program with insight from various members of a clinical trial team.

11:30 Session Break

AUDITING FOR VENDOR QUALIFICATION AND PERFORMANCE

1:25 Chairperson’s Remarks

Anthony Borisow, Senior Quality Manager, Clinical Quality Assurance, Vertex Pharmaceuticals Inc.

1:30 We Hold This Truth to Be Self-Evident: NOT All GCP Vendors Are Created Equal

Robyn Lori, Director, GCP Vendor Management, Vertex Pharmaceuticals

Any given clinical trial may have a number of different vendors participating, with each contributing to the trial in different ways. With this in mind, how do we determine the frequency with which we should audit each vendor? This talk will discuss Vertex’s risk-based strategy to determine how often audits should be performed to ensure that each trial stays on schedule.

2:30 Refreshment Break in the Exhibit Hall

3:15 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format, please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

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4:15 Welcome Reception in the Exhibit Hall

5:30 Close of Day

5:30 Dinner Short Course Registration

Tuesday, April 25

7:25 am Morning Coffee

HEALTH AUTHORITY INSPECTIONS

7:55 Chairperson’s Remarks

Andy Lawton, Director and Consultant, Risk Based Approach Ltd.

8:00 Actionable Insight from Health Authority Inspections

Janis Little, Vice President, Global Regulatory Quality, Allergan

As the trend toward health authority inspections grows, companies must be prepared to adjust their operational models to be prepared for these visits. This talk will address the trends in inspections, how common they are, and how to prepare for an audit of clinical trial documentation during mergers and acquisitions. Allergan’s “open science” model will also be discussed.

8:30 Lessons Learned from mHealth Canada Health Authority Inspection

Derek Hall, Associate Director, Quality Assurance GCP, Incyte

This talk will discuss Incyte’s experience with their recent health authority inspection at mHealth Canada. Lessons learned revolve around policies, documentation, and validation.

ICH E6 R2: EFFECTS ON AUDITING

9:00 ICH E6 (GCP) Addendum – Impact on Use of Audits?

Andy Lawton, Director and Consultant, Risk Based Approach Ltd

ICH GCP (E.6) Addendum was released in December last year and is due to be implemented in mid 2017. ICH GCP forms the basis for companies to undertake clinical trials and so it is essential that preparations are made to build the changes from the addendum into our processes, and yet a large number of companies have not fully addressed the changes. The main changes and the focus of this presentation are in the area of auditing, although not directly addressed the introduction of quality tolerance limits will be a natural limit to the use of audits. This talk will allow attendees to understand the changes in ICH GCP (E6) and the drivers for them, the impact on sponsors, and the essential steps to take for ICH E6, including gap analysis, an action plan, and a project plan.

10:00 Coffee Break in the Exhibit Hall

1:20 Close of Clinical Trial Auditing. Stay on to attend Mastering Risk-Based Monitoring.