How to comply with ICH GCP 2 Addendum

Overview:

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.

It is important to understand the changes required by the new ICH GCP R2 Addendum. To consider how SOPs, procedures and audit checklists 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.

Why should you Attend:

• Understand the requirements of the updated ICH GCP R2 guideline
• Hear about the future ICH major revision planned
• Review the new requirements for what inspectors should look for
• Review best practice of these additional new GCP requirements

Areas Covered in the Session: 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.

Areas to be covered include:

• Sponsor Oversight
• Risk Based Quality Systems
• Risk Based Monitoring
• Data Management
• Certified Copies
• Investigator Site Audit
• The Trial Master File

Who Will Benefit:

• Clinical Research Managers, VPs and Directors
• Quality Assurance for Clinical Trials /GXP
• Study Site Staff including investigators
• CROs and Other Vendors Working on Clinical Trials
• Data Management
• Pharmacovigilance for Clinical Trials
• Risk and Compliance Managers Responsible for Clinical Trials
• Auditors
• SOP Writers
• Document Management

Speaker Profile
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.