국가임상시험지원재단

● ICH GCP (R2): Quality Management System & Risk Management

Helen Wong(MSD)?

The ICH Good Clinical Practice (GCP) was firstly finalized in 1996. Throughout the years, the technology used in clinical trials as well as risk management processes have been advanced. ICH E6 Revision 2 (R2), released in Nov 2016, introduced some new concepts and minimum standards in the design, conduct, recording and reporting of clinical trials.
- Report the quality management approach used and important deviations
Risk Management concept is utilized in ICH GCP (R2) which describes QMS should use a risk-based approach in QMS to:
- Identify critical process and data
- Identify risks, Evaluate risks, Control the risk
- Communicate the risk and actions taken, if any.
- Periodically review the risk
- Report the quality management approach used and important deviations ?

● How to Embed cQMS into Daily Work

Hannah Chen(J&J)

Clinical QMS should be Proactive, risk-basked, flexible. It should be tailored based on organization’s portfolio, regulatory environment, to ensure the design of the Clinical QMS and its elements will be “fit for purpose” and can support the quality goal which aligned with business objectives.
System, process and people are the three components of quality system, among which people makes difference. Organization needs to put efforts in building a quality culture, because we see issues still occur where there are system and process in place. Leadership commitment and organization commitment to quality, and continual improvement are the foundation of the quality framework . Senior management behavior, the way we measure performance, and even the organization structure will impact the quality culture and employee’s behavior.

● The Role of Quality Assurance in Multi-Center Trials

Choy Kiew Cheong(IQVIA)

What is the role of Quality Assurance (QA)?  Is it to be a “Policeman” or a “Pro-active Partner” to ensure high quality standards in the delivery of clinical trials?
Given the current environment wherein clinical trials are getting more complex, with directives from senior management to accelerate subject recruitment and timelines, designing multi-country trials including engaging with naive trial sites, the role of QA is seeing a shift from the traditional auditor role to one that is more pro-active, supporting teams to identify and managing risks to prevent potential errors that matter to decision making, ultimately with the single aim in mind of achieving successful regulatory inspection outcomes thus bringing life changing medicines to help improve patients’ lives
But is that all the auditors do? 
Given the current environment wherein clinical trials are getting more complex, with directives from senior management to accelerate subject recruitment and timelines, designing multi-country trials including engaging with naive trial sites, the role of QA is seeing a shift from the traditional auditor role to one that is more pro-active, supporting teams to identify and managing risks to prevent potential errors that matter to decision making, ultimately with the single aim in mind of achieving successful regulatory inspection outcomes thus bringing life changing medicines to help improve patients’ lives?

1. Helen Wong(MSD)

2. Hannah Chen(J&J)

3. Choy Kiew Cheong(IQVIA) 

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[별표 1]

임상시험등 종사자별 교육과정 및 이수시간

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