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AUDITS & INSPECTIONS

Barnett International , London, UK
September 16-17, 1999

Program:
BARNETT INTERNATIONAL’S

AUDITS & INSPECTIONS
Accelerate Global Drug Approval through GCP Compliance

September 16-17, 1999
Regents Plaza Hotel And Suites, Plaza Parade, London

Up-to-the-Minute and In-Depth Discussion from the Experts with…
Unparalleled Industry Representation

Bayer
Baxter Healthcare
PAREXEL International
Pharm-Olam International
ClinAudits
MORIAH Consultants
Astra Pharmaceuticals
Eli Lilly & Company
Quintiles GmbH
Blandy & Blandy
AMGIT
Clinical QA & Quality Management Services
META Solutions

Plus representation by a former FDA Reviewer

Outstanding Answers to Today’s Questions:
 Using FDA Findings to Minimize Risk and Exposure of Sponsors and Investigators
 Detection, Handling and Prevention of Fraud
 Compliance with Electronic Signatures and Records
 Ensuring Data Integrity: Auditing New GCP Electronic Systems
 Maximizing Benefits of Audits of Databases & Data Management Systems

PLUS
Sites are Always Ready for an Audit: A Walk-Through of Monitoring Visits

Barnett International is approved by the American Council of Pharmaceutical Education as a provider of continuing education credits.
September 16, 1999

8:30
Breakfast & Registration

Increase Regulatory Compliance and Minimize Risk

9:00
Chairperson’s Welcome & MCA Audits and Inspections
Invited: Anya Sookoo, GCP Inspector, Medicines Control Agency

9:45

Using FDA Findings to Minimize Risk and Exposure of Sponsors and Investigators

Michael Hamrell, PhD, RAC, President, MORIAH Consultants, California, USA

The FDA continues to emphasize the inspection of clinical studies for medical products as a QA tool. New strategies in FDA enforcement has resulted in an increasing number of actions involving clinical investigators and companies resulting from the audit of clinical studies. The planning and organization of the study can affect the quality of the data collected and the acceptability of the clinical data by the FDA. Understanding these issues can help to minimize the risk and reduce the exposure for the Sponsor and the Clinical Investigator. This session will also discuss recent FDA findings and trends from the inspections of clinical studies.

10:30
Break

10:45
Improving Quality and Consistency of ICH GCP Compliance
Rick Walsh, Quality Department, Astra

With the acceptance of ICH guidelines for Good Clinical Practice, the FDA and other regulatory bodies expect more effort on the part of sponsors, investigators, IRBs, central facilities and CROs to ensure their responsibilities have been met. This presentation will focus on current and future regulatory activities and how you can take steps to improve the quality and consistency of your efforts and ensure compliance with ICH GCPs.

11:30
Practical Implementation of the ICH Guidelines in the United States
Cheri Wilczek, President, ClinAudits, LLC

This presentation is designed to help those involved in every phase of the clinical research process to better comprehend the practical implementation of the ICH guidelines. Although the process of clinical development in the US has long been governed by the applicable parts of Title 21 of the US Code of Federal Regulations, not until 1997 did the FDA issue the long-awaited final version of the comprehensive GCP document intended to bring together all the existing regulations under a single coherent title. Session attendees will:
 Expand awareness of GCP
 Develop knowledge of ICH guidelines and ICH regulations
 Identify the updated differences between FDA regulations and ICH guidelines

12:15
Lunch

Maximize Auditing and Monitoring Results

1:15

The Sponsor’s Ongoing Role in Preparing for a Site Inspection

Carl Verlinde, Regional Clinical Coordinator, Eli Lilly & Company

This presentation concentrates on the role the sponsor can play and the activities that can be developed to prepare a site for an inspection. The talk concentrates on practical examples which have been set-up by a pharmaceutical company to assist a site.
 Practical solutions to prepare the site for an inspection
 Ongoing activities by the sponsor
 What can be done at different levels

2:00

Accumulating Audit Results and Feedback into the Quality System: Study Audits

Ursula Streicher-Saied, Head of Clinical Quality Management Europe and Overseas, Bayer plc Medical Affairs

The routine audit cycle often implemented in companies focuses on performing audits, communicating audit findings and resolving the findings on an individual audits basis. There are other ways to use the results of audits to benefit an organization which are much more beneficial. Some of the ways to explore include using cumulative results of audits to identify weaknesses and focus resources to fix and identify trends and trace back to root causes. The most effective way of being able to perform this type of audit is to plan for it up-front in the design of audit methodology and adaptation of the audit process to facilitate this.

2:45
Break

3:00
Assessing Documentation and Collection Forms
Lillian Natorff, Medical Director, Pharm-Olam International

Some basic principles of data quality are formally stated in the ICH Guidelines for Good Clinical Practice. Data quality standards are not formally defined in GCP regulations, however, source data from “adequate and well-controlled” clinical trials supporting marketing applications to the FDA, on the grounds of statistical and experimental control, should reflect the same elements for data quality and integrity. This presentation will discuss the importance of data quality, provide suggestions for source documentation design, and highlight the implications of inadequate documentation procedures. In addition, examples of good and unacceptable documentation and data collection forms will be examined.
Learn how to ensure the following:
 Support and validate entries in CRFs and demonstrate compliance with protocol
 Proper documentation of edits, and additions or corrections to patient or subject generated data
 Facilitation of data integrity and validity
 Site personnel’s adherence to proper data correction procures in source documents


3:45
Auditing Clinical Labs & How to Avoid Common Problems
Dawn Livingstone, Senior Auditor, Bayer Medical Affairs, Europe & Overseas

The Quality Standard, which should be applied when auditing clinical laboratories, is a much debated question. This session shall compare the elements required by selected Quality Standards, which are applicable to laboratories participating in clinical studies. The presentation shall also demonstrate one specific approach that may be taken to the audit of routine laboratories. In addition, problematic areas commonly identified during audits will be discussed.

4:30

Ensuring Sites are Always Ready for an Audit: A Walk-Through of Monitoring Visits

Alexandra Hopwood, Project Manager, Baxter Healthcare LTD Clinical Affairs

This presentation will explore the purpose behind the procedures carried out at monitoring visits. Ways to make the most of such visits to ensure sites are always ready to be audited will be discussed. Other site visits, such as pre-study site visits and close-out visits and their importance in ensuring GCP compliance are addressed.

 Keep on top of drug accountability
 Screen out problem investigators early
 Spot protocol compliance issues

5:45
Close of Day One


September 17, 1999

9:00
Conducting Successful Pre-Contract Assessments and Post-Contract Audits of Contract Research Organizations
Caroline Gasson, Director, AMGIT

Use of CROs to supplement sponsor resources is increasing in the clinical trials industry. Quality Assurance often participates in this process by conducting pre-contract QA assessments focusing on the quality systems in place at the CRO. Such assessments tend to be one-day activities and rather subjective as actual study conduct cannot be reviewed and validated against standard operating procedure requirements. Routine reassessments while studies are ongoing can provide more useful information.



9:45
Detection, Handling and Prevention of Fraud
Joachim Schwarz, Quintiles GmbH

The problem of fraud and scientific misconduct in clinical studies, although in decline since the introduction of GCP standards, is still a pressing one. Fraud may be defined as the deliberate reporting of false or misleading data, or the withholding of reportable data. This presentation will define the three types of fraud, how to detect fraud, effectively and efficiently handle fraud once detected during an audit or inspection, and also how to use the auditing and monitoring processes to prevent fraud.

10:30
Break

10:45
Early Intervention and Solutions for the Problem Site
Mike Hammond, Clinical QA & Quality Management Services

Avoid costly mistakes that can be prevented through auditing and monitoring.
 What triggers an Inspection?
 Identify fraud and misconduct
 Handling unusual findings
 Responding and reporting
 Early intervention methodologies


11:30
The Impact of the Data Protection Act 1998 on Clinical Trial Data: Data Protection and the New Regime
Kathy Minter, Solicitor, Corporate & Commercial, Blandy & Blandy

To date, is does not appear that the data protection has had a significant impact on the public consciousness. This new legislation, together with legislation in the field of human rights and freedom of information, will undoubtedly increase public awareness. This presentation examines the impact the legislation will have on the handling of clinical trial data and the rights of clinical trial subjects, looking specifically at the new data protection principles and how you can comply with:
 Extension of data subjects’ rights to access data;
 Requirements for the processing of “sensitive” data;
 New controls imposed of trans-border data flows through the use of model contract clauses.

12:15
Lunch

Successful Auditing and Monitoring of Electronic Systems


1:00
Compliance with Electronic Signatures and Records
Len Grunbaum, President, META Solutions, Inc.

A number of presentations have been made to describe the Part 11 regulations, but there has been little practical advice on how to achieve compliance. Typical approaches have focused on specific types of systems or large, mission-critical systems. However, these approaches result in compliance with only these particular systems, and not the entire enterprise. This presentation will provide a strategic approach to enable the entire organization to prepare for compliance with the new electronic signatures/electronic records regulations. Particular attention will be given to developing a corporate methodology and plan for the various technical, business and compliance functions to effectively and efficiently achieve compliance.


2:00
Maximizing Benefits of Audits of Databases & Data Management Systems
Cathy Griffiths, Senior Manager, Quality Assurance, PAREXEL

In addition to investigator and on-site audits, conducting audits of in-house project databases and data management systems as a whole can provide extremely valuable information on the overall quality of the study data. This presentation will focus on how best to maximize the conduct, and report such audits as well as how to maximize the expected benefits across both the clinical and data management groups.

3:00
Ensuring Data Integrity: Auditing New GCP Electronic Systems
Len Grunbaum, President, META Solutions, Inc.

GCP electronic systems are present throughout all phases of the modern clinical research process. New challenges in compliance assessment are generated for quality assurance compliance auditors. The challenges include assessing electronic system integrity for data quality, adequacy of the available documentation, and developing an increased skill and comfort level when auditing new systems. This presentation will describe strategies for auditing new electronic systems. Audit preparation is an important step to ensure an effective and efficient audit. The first step for the audit team is to gain an overall definition and understanding of the electronic system. Also, determining the distribution of appropriate credit enhances the
Communication process during the audit feedback discussions. Finally, the suggestions for important questions regarding data integrity will be discussed.


4:00
End of Conference

Registration :
$1,795 USD (for discount information, contact tracy.trauger@parexel.com)

Deadline for Abstracts: N/A

Email for Requests and Registration: customer.service@parexel.com


Posted by: Tracy Trauger Host: parexel.com date: June 18, 1999 12:52:56
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