PDF《临床质量保证培训课程》

2011 Drug Information Association ISBN 978-1-4507-7152-8

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t underestimate the impact of electronic applications and computerized systems ? Further develops the standards set forth by Computerized Systems Used in Non Clinical Safety Assessment ? Intended to set a benchmark for requirements of computerized systems used in clinical research Visit www.diahome.org/peach for more information ORDER NOW! Special Member Pricing September 25,

2012 China Pharmaceutical University(CPU) | Nanjing, China Enrollment limited. Register Early! Good Clinical Practice (GCP) is a compilation of best practices and quality standards to be applied to the overall process of a clinical trial. The ultimate goals of quality in clinical research are to ensure patient safety and data integrity. This training will introduce concepts for ensuring quality, which are not limited to quality in clinical research;

rather they are processes and risk controls, systems, data integrity associated with quality, and manufacturing of clinical products from industry and regulations that form the basis for the best practices. The understanding of these best practices will form the foundation for applying quality management system (QMS) to the conduct of clinical research and more specifically, for managing the SLC of clinical data generated from clinical trials. FEATURED TOPICS ? Foundation of ICH-GCP standards ? Industry GCP-compliant and expectations of quality management system ? Critical and core infrastructure of clinical out- comes: data quality and integrity ? Basic concepts and procedures of project and risk management ? Detection and measurement of fraud data in clinical trials ? Building quality structure in the change control of clinical processes ? Relationship of GMP-compliant drug supply to GCP quality management LEARNING OBJECTIVES At the conclusion of this course, participants should be able to: ?? Understand the principles of ICH-GCP E6 as they impact clinical quality system ?? Describe in-depth the expectation and challenges of the project and risk manage- ments as well as more efficient management and communication of trial processes in the clinical study world ?? Understand the importance and relation- ship of data quality and integrity, which constructs a critical foundation in the reliable and accurate outcomes from clinical trials Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association. Speakers and agenda are subject to change without notice. Recording of any DIA training material in any type of media, is prohibited without prior written consent from DIA. For general inquiries and registration, contact Mr. Fei XIE Phone +86.10.6260.2240 [email protected] or [email protected] PROGRAM CHAIRPERSON Daniel LIU, PhD Director, China Development Medidata Solutions Worldwide, China PROGRAM COMMITTEE Eric HERBEL President, Integrated Clinical System, Inc., USA Jingrong LI, PhD Simcere Inc, China Mary Ann MORRIS Associate Consultant, Medical Quality System, Eli Lilly and Company, USA Rong SHAO, Professor Dean, School of International Pharma- ceutical Business, China Pharmaceutical University, China u? Trial quality assurance and quality control professionals u? Trial project managers u? Trial project administrators u?Trial monitors u? Trial data managers u?Trial auditors u? Clinical development professionals u? Clinical regulatory affairs professionals u? Clinical researchers and study coordinators WHO SHOULD ATTEND Training on Clinical Quality Compliance Best Practice for Good Quality Management in Clinical Studies Metropolis Tower 7th Floor I Room #766 I No.2 Haidian Dong San Street I Zhongguancun Xi Zone I Haidian District, Beijing 100080, China Tel. +86.10.6260.2240 Fax. +86.10.6260.2201 www.diachina.org, [email protected] ?? Learn the best practice in the change- able environment of clinical processes as well as the management and implementa- tion of change controls ?? Identify and establish strategies and quality enhancements in the GMP associated with GCP world ? Be familiar with management and assess- ment of quality management system in the standpoints of clinical project needs ? Prepare the participants to contribute positively themselves to implementation, operation and management of the real daily life as clinical trial practitioners The training course provides the opportunites for Table-tops and Advertisements in colors on event mate- rials: Full-page and Half-page. The deadline of advertisement application is September 10th, 2012. Please contact Ms. Runshan CHEN by [email protected] or +86.10.6260.2240 CO-SPONSORS China Pharmaceutical University Chinese Pharmaceutical Association Jiangsu Branch Information Center of State Food and Drug Administration