On-line training course on GCP audit and inspection

Overview :

This GCP auditing course is designed to provide practical training resulting in a harmonised, common audit methodology in Europe. The ICH GCP guideline implemented in the EU, Japan and the USA is being widely incorporated into guidelines worldwide. Systems audits, previously seen as “advanced auditing”, have become a basic task of many audit groups and are an essential element of inspections in Europe.

The course material is regularly updated with the objective of experience sharing and a common professional approach in order to pave the way for mutual recognition and acceptance, reducing costs and stimulating efficiency, allowing faster medicinal product development to the benefit of the patients and health care.

Key Topics

Regulatory framework EU and ICH

Quality management, defining quality, risk-based approach to audit and inspection

Trial audit in practice

System audits

Communication of audit findings

Inspections by European and other authorities

GCP audit and inspection training materials:

A must-have guide for any professional in the drug manufacturing industry

这 良好的临床实践 (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code.

Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards.

This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits.

The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals.

Among the topics discussed:

Good Clinical Practices and therapeutic product development in clinical research

The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee

The roles and responsibilities of the clinical trial investigator

The inspection preparation

The Audit Report and the Form 483

Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development

Learning Objectives

Upon completion, attendees will be able to:

Identify and define the principles and requirements for GCPs

Define the basic roles and responsibilities of the sponsor, monitor, investigators and FDA as they relate to the quality of clinical trials

Understand the GCP audit process for sponsors

Know when to conduct audits of vendors, sites, IRBs and laboratories

Ensure that your data and supporting documentation are accurate and presentable for inspection

Gain knowledge concerning common outcomes and findings in clinical trials

Understand how to respond to an audit to avoid further regulatory consequences

Learn how to detect and prevent fraud and misconduct in clinical trials

Fully understand the consequences which result when proper procedures are not followed, through the use of examples

Case study analysis, exercises and videos will be used throughout the course to provide insight and promote discussion.

一种 GCP audit training package has been developed on the basis of the documents developed byICH Steering Committee Members.

We wish to thank to:

博士. Peter Arlett
Head of Sector for Pharmacovigilance and Risk Management
European Medicines Agency London UK

博士. Tomas Salmonson
Medical Products Agency
Preclinical and Clinical Investigation Unit Uppsala, Sweden

博士. Christine-Lise Julou
European Federation of Pharmaceutical
Industries Associations – EFPIA Brussels, Belgium

博士. Andrй W. Broekmans
Schering Plough Research Institute The Netherlands

Mr. Shinobu Uzu
Ministry of Health, Labour & Welfare Tokyo, 日本

博士. Satoshi Toyoshima
Pharmaceuticals and Medical
Devices Agency (PMDA) Tokyo, 日本

Mr. Kazutaka Ichikawa
Japan Pharmaceutical Manufacturers
Association – JPMA Tokyo, Japan Mr. Kohei Wada
Asia Clinical Development Department
Daiichi Sankyo Co., Ltd. Tokyo, 日本

博士. Justina A. Molzon
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration Rockville, 医学博士, 美国

博士. Robert A. Yetter
Center for Biologics Evaluation and Research (CBER)
Food and Drug Administration Rockville, 医学博士, 美国

博士. Alice Till
Science Policy and Technical Affairs
Pharmaceutical Research and Manufacturers of America – PhRMA
Washington DC, 美国

博士. Peter K. Honig
Worldwide Regulatory Affairs and Product Safety
Merck Research Laboratories North Wales, PA, 美国

Mme Alicia D. Greenidge
International Federation of Pharmaceutical
Manufacturers Associations – IFPMA Geneva, Switzerland

博士. Odette Morin
Director of Regulatory and Scientific Affairs
International Federation of Pharmaceutical
Manufacturers Associations – IFPMA Geneva, Switzerland

Mr. Mike Ward
International Policy Division
Bureau of Policy and Coordination
Therapeutic Products Directorate
Health Products and Food Branch Health Canada

博士. Lembit Rago
Quality Assurance and Safety : Medicines
HTP/EDM/QSM
World Health Organization Geneva, Switzerland

博士. Petra Doerr
Swissmedic, Swiss Agency for Therapeutic Products
Berne, Switzerland