GCP审核和检查的在线培训课程

概述 :

这 GCP审计课程 旨在提供实用的培训，导致一致, 欧洲的常见审计方法. 欧盟实施的ICH GCP指南, 日本和美国已被广泛纳入全球指南. 系统审核, 以前被视为 “高级审计”, 已成为许多审核小组的基本任务，并且是欧洲检查的基本要素.

该课程材料定期更新，目的是经验共享和一种常见的专业方法，以便为相互认可和接受铺平道路, 降低成本并刺激效率, 允许更快的药物开发为患者和医疗保健带来好处.

关键主题

监管框架欧盟和ICH

质量管理, 定义质量, 基于风险的审计和检查方法

实践中的试用审核

系统审核

审计发现的沟通

欧洲和其他当局的检查

GCP审核和检查培训材料:

药物制造业中任何专业人员的必备指南

这 良好的临床实践 (GCP) 审计 是一项乏味但必要的练习，可以确保所有各方都正确地完成工作并符合适用的FDA代码.

临床试验审计准备旨在为所有涉及各方的审计过程神秘, 包括临床研究赞助商, 临床研究人员, 和机构审查委员会.

本书为临床试验的FDA审核程序以及制药公司的方式提供了分步的解释。, 临床研究人员, 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, 临床研究人员, 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审核 process for sponsors

Know when to conduct audits of vendors, 站点, 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.

一个 GCP audit training package has been developed on the basis of the documents developed by ICH 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, 比利时

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) 东京, 日本

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

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

博士. Robert A. Yetter
Center for Biologics Evaluation and Research (CBER)
Food and Drug Administration Rockville, MD, 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, 瑞士

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

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, 瑞士

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