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Training Course
Understanding and Implementing
Best Ethics Practices in Clinical Research

 

This two-day course provides an in-depth, practical, and interactive forum so trainees can better understand the critical aspects of ethical requirements, appropriate patient protection, and the Informed Consent Process throughout clinical trials. Supported with examples of real-life experience, this course will deliver a comprehensive understanding of internationally accepted and requested ethical considerations in clinical trials, of an appropriate ethical review process, and the elements of a patient-adapted informed consent process. The trainer will also compare Chinese requirements and ICH/European/US requirements with special focus on ethical review, the informed consent process and issue management by providing practical cases.

 

Session and Abstract Topics
· The history of biomedical research ethics leading to the Declaration of Helsinki and ICH GCP
· Ethical requirements for clinical trials in China
· Patient protection in clinical trials from Phase 1 to Phase 4, including post marketing observational trials
· The ethical review process to ensure reliable patient protection and ethical conduct of clinical trials
· Identifying ethically critical aspects of a protocol provided for review
· The Informed Consent Process in trials with conscious, adult participants
· Critical review of a Patient Information Sheet and the informed consent process
· Ethical issues in clinical trials involving vulnerable adult populations and children
· Different case studies will be presented and the delegates will be asked to identify what the ethical issues are and how these can be addressed
· When support to and compensation of patients in clinical trials become an inducement
· Research integrity, ethics and social responsibility when conducting clinical trials and ethical responsibilities when things go wrong

 

Learning objectives
At the end of the training course, participants should be able to:
· gain a better understanding of the ethics requirements and impacts in conducting clinical research
· have a better understanding of GCP, ICH and the SFDA new guideline for ethics
· follow the regulatory compliance effectively
· design good clinical studies with good ethics practices to ensure successful compliance inspections and regulatory submissions

 

Who should attend
· Medical professionals
· Clinical project managers, directors, group leaders
· Clinical trial/study site investigators
· Medical affairs professionals and medical directors
· Regulatory affairs professionals
· R&D scientists
· Public health policy makers

 

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PROGRAM COMMITTEE

PROGRAM CHAIRPERSON

Haiyan LI, MD, Professor
Director, Drug Clinical Trial Center, Peking University Third Hospital
Vice Director, Peking University Clinical Research Institute, China

 

PROGRAM COMMITTEE

Beat E. WIDLER, PhD (Main Instructor)
Europe Clinical QA & Risk Management Expert, Switzerland

 

Haitao LIU, MD, Master of International Public Health
Senior Advisor, Clinical Development Quality Assurance Asia Pacific, Global Quality and Compliance, GlaxoSmithKline R&D, China

Date Time

2012-12-03 08:30 - Start

2012-12-04 17:30 - End

Ended
Address
  • 中国 北京 海淀区
  • Peking University Health Science Center, Xueyuan Road