How to Audit Against ICH GCP 2 Addendum to Ensure Compliance
This informative session will cover these new requirements for auditing clinical trials, evaluate the changes and understand how these impact on auditors, also Review best practice of these additional new GCP requirements for auditors.
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It is important GCP Auditors to understand how to audit the changes required by the new ICH GCP R2 Addendum. To consider how audit checklists and procedures should have been updated to ensure the new requirements are met and their organisations are ready for regulatory inspection. The session will also include an update on the proposed further major revision of ICH GCP R2 planned by ICH to start later next year. The new guideline includes a number of "hot" GCP inspection topics which are also covered in a number of other EU and FDA guidelines and documents, such as risk-based approaches for running clinical trials. These new approaches are going to be areas inspectors will be focussing on.
Why should you Attend:
This informative session will cover these new requirements for auditing clinical trials, evaluate the changes and understand how these impact on auditors. This will enable you to meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.
Areas Covered in the Session:
Who Will Benefit:
- Understand the new requirements of the updated ICH GCP R2 guideline for auditors
- Hear about the future ICH major revision planned
- Review the new requirements for what auditors should look for Sponsor Oversight, Risk based quality systems, risk based monitoring, data management, Investigator site audit, the trial master file
- Review best practice of these additional new GCP requirements for auditors
- QA Professionals
- Clinical Research/Clinical Operations
- Regulatory Affairs
- CRO, Regulatory Authorities
- Clinical Trial Personnel
- Quality Assurance
- All other Professionals who want to know more about the new ICH GCP (R2) guideline
Dr. Laura Brown , PhD, MBA, Diploma Clinical Sciences, is an independent QA and training consultant in the pharmaceutical industry. She is a managing director with LB Training and Development Ltd., course director for the M.Sc. in Clinical Research, School of Pharmacy at the University of Cardiff, and course director for M.Sc. Regulatory Affairs, TOPRA.
Dr. Brown has 20 years experience running clinical trials and clinical quality assurance in the pharmaceutical industry, and auditing clinical trials internationally. She has held a number of international and senior management QA positions in the pharmaceutical industry including her role as an associate director with a leading GCP audit consultancy.
She has worked for several international companies like GlaxoWellcome, Hoechst Marion Roussel and Phoenix International.
Dr. Brown has published material on the new EU Clinical Trial Regulation and also a practical guide to the current regulatory requirements for carrying out clinical trials in the EU. She has penned a chapter on training QA staff in the leading GXP book "Good Clinical, Laboratory and Manufacturing Practices" (2007).
She has authored SCRIP's latest GCP guide and one entitled "Practical Guide to the Clinical Trial Directive". She is also co-author of several books including "Developing the Individual" and "Project Management for the Pharmaceutical Industry". She has regularly lectured at conferences and in training courses on QA and GXP issues.
Dr. Brown developed an e-learning module: "How to Prepare for Audit and Inspection" for Zenosis (a regulatory commercial e-learning training organization) in 2008 and is editor of an e-learning SOP series for Henry Stuart Conferences (2013).
She runs many training courses on topics such as: pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, GCP, regulatory requirements for clinical trials, the clinical trial directive, managing clinical trials, QA management and business skills, how to prepare for audit and inspection, how to audit, etc.