GCP denetim ve incelemesine ilişkin çevrimiçi eğitim kursu

Genel Bakış :

This GCP auditing course is designed to provide practical training resulting in a harmonised, common audit methodology in Europe. AB'de uygulanan ICH GCP kılavuzu, Japonya ve ABD, dünya çapındaki kılavuzlara geniş çapta dahil ediliyor. Sistem denetimleri, previously seen as “advanced auditing”, Avrupa'da birçok denetim grubunun temel görevi haline gelmiş ve denetimlerin temel bir unsuru haline gelmiştir..

Karşılıklı tanınma ve kabulün önünü açmak amacıyla, deneyim paylaşımı ve ortak mesleki yaklaşım hedefiyle ders materyali düzenli olarak güncellenmektedir., maliyetleri azaltmak ve verimliliği teşvik etmek, Hastaların ve sağlık hizmetlerinin yararına daha hızlı tıbbi ürün geliştirilmesine olanak sağlamak.

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

The İyi Klinik Uygulamaları (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:

İyi Klinik Uygulamaları 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

Öğrenme Hedefleri

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.

A GCP audit training package has been developed on the basis of the documents developed by ICH Steering Committee Members.

We wish to thank to:

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

Dr.. Tomas Salmonson
Medical Products Agency
Preclinical and Clinical Investigation Unit Uppsala, İsveç

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

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

Mr. Shinobu Uzu
Sağlık Bakanlığı, Labour & Welfare Tokyo, Japonya

Dr.. Satoshi Toyoshima
Pharmaceuticals and Medical
Devices Agency (PMDA) Tokyo, Japonya

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

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

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

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

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

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

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

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

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

Dr.. Petra Doerr
Swissmedic, Swiss Agency for Therapeutic Products
Berne, İsviçre