교육신청
- 전체
- 종사자 공통(GN)
- 임상연구자(PI, Sub-I)
- 심사위원회 위원(IRB)(의사, 의사 외)
- GCP
- 관리약사(CRP)
- 임상시험 코디네이터(CRC)
- 임상시험 모니터요원(CRA)
- 실시기관 품질보증 담당자(QA)
- 실무 통합(IN)
- 임상시험 데이터관리(DM)
- 프로젝트 매니지먼트(PM)
- 임상시험통계(STAT)
- 메디컬라이터(MW)
- 약물감시(PV)
- 규제과학·인허가(RA)
- 기업주도
- 수요자맞춤(기업,대학)
- KIC
[KIC > 심화]
2020 KoNECT International Conference Workshop_심화/보수
구분
비대면교육
카테고리
KIC > 심화
과정명
2020 KoNECT International Conference_심화/보수
교육대상자
임상시험종사자 직능(식약처 기준)
시험책임자(PI) / 시험자(SubI) / 관리약사 / IRB위원(의사) / IRB위원(의사 외) / 코디네이터(CRC) / 품질보증담당자(QA) / 모니터요원(CRA)교육단계
심화 /
보수
신청기간
2020.09.10 (10:00) ~ 2020.09.10 (24:00)
교육기간
2020.10.06 ~ 2020.10.06
학습일수/시간
1 일 / 6
시간
교육장소
2020 KIC Virtual
수강료
무료
교육정원
인원제한없음
소개
목차
교육일정
일정표
| [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) | |||
수료/과락 기준
| 평가기준 | 집합 출석율 | 온라인 진도율 | 시험 | 과제 | 토론 | 기타 |
|---|---|---|---|---|---|---|
| 배점비율 | 50.00% | - | 50.00% | - | - | - |
| 과락기준 | 80% | - | 60점 | - | - | - |
