[KIC > 심화]
임상시험종사자 직능(식약처 기준)
시험책임자(PI) / 시험자(SubI) / 관리약사 / IRB위원(의사) / IRB위원(의사 외) / 코디네이터(CRC) / 품질보증담당자(QA) / 모니터요원(CRA)심화 /
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[Workshop 1 & 2] PROGRAM DETAILS | ||||
October 6(Tue) | ||||
Time | Program | Speaker | Affiliation | |
[Workshop 1] Mastering Risk-Based Monitoring & Quality Management | ||||
09:30~10:50 | Mastering Risk-Based Monitoring & Quality Management - Part 1 | Chair : Yoon-Duk Han, Hye-Jong Yoo | ||
09:30~10:10 | W1.1-1 | RBM overview & methodology: on-site, off-site & central monitoring (including Regulatory Guidance) | Eehwa Pae | Bristol Myers Squibb |
10:10~10:50 | W1.1-2 | Study Risk Management Plan: How to manage a Risk in SRMP? | Hyewon Song | Sanofi |
10:50~11:00 | Break | |||
11:00~12:40 | Mastering Risk-Based Monitoring & Quality Management - Part 2 | Chair : Yoon-Duk Han, Hye-Jong Yoo | ||
11:00~11:25 | W1.2-1 | Mock Site Risk Assessment | Ji-Hee Kwon | AstraZeneca |
11:25~11:40 | W1.2-2 | Challenges & Opportunities of Risk Based Monitoring | Sun-Ha Park | Roche |
11:40~11:55 | W1.2-3 | Case study - Challenges & Opportunities (TransCelerate initiative) | Hyunju Park | CKD Pharmacy |
11:55~12:20 | W1.2-4 | Measuring The Impact Of Risk Based Monitoring: The PAST, PRESENT & FUTURE of RBM METRICS | Yoon-Duk Han | Pfizer(TransCelerate) |
12:20~12:40 | Q&A (Workshop1-Part1&2) | |||
12:40~14:00 | Lunch | |||
[Workshop 2] Biotech Boot Camp | ||||
14:00~15:40 | Biotech Boot Camp - Part 1 | Chair : James Lee | ||
14:00~14:50 | W2.1-1 | What is RBM and How to Adopt It More Effectively? | Jason Junghwe Koo | LB Investment |
14:50~15:40 | W2.1-2 | Key Role of Centralized Monitoring - Going forward in RBM - | Jungseob Shin | KB Investment |
15:40~15:50 | Break | |||
15:50~17:30 | Biotech Boot Camp - Part 2 | Chair : James Lee | ||
15:50~16:20 | W2.2-1 | From Molecule to IND | Yun Jeong Song | ImmuneOncia |
16:20~16:45 | W2.2-2 | How to Prepare IND | Kisuk Kim | C&R Research |
16:45~17:10 | W2.2-3 | Project Management: Steering Ultimate Project Success with CROs | Jenny Shin | Syneos Health |
17:10~17:30 | Q&A (Workshop2-Part1&2) |
평가기준 | 집합 출석율 | 온라인 진도율 | 시험 | 과제 | 토론 | 기타 |
---|---|---|---|---|---|---|
배점비율 | 50.00% | - | 50.00% | - | - | - |
과락기준 | 80% | - | 60점 | - | - | - |