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수강료 : 440,000원
[모니터요원 심화/보수과정] Medical Writing in Clinical Research [16H]
[약사법] 및 [의약품 등의 안전에 관한 규칙]에 따른 모니터요원(CRA),
Medical Writing 업무를 하고 있는 분
1. 출석(16시간중 80%이상 참석), Test(60점 이상) 모두 만족 시 수료증 발급
2. Test 응시는 교육 당일 자정(24:00)까지 온라인으로 응시 가능합니다. Timeline을 넘기면 수료가 되지 않습니다.
Course Title: Medical Writing in Clinical Research Part 1 |
Presenters: Kim, Kisuk (RA Manager) · Lee, Eunju (Sr.Medical Writer) · Chung, Yongju (Medical Part Manager, Medical Advisor, MD) · Ahn, Byungjin (Chief Medical Officer[JE1] , Vice President of C&R Research, MD) |
Participants: Medical Writing 업무를 하고 있는 분 또는 임상시험관련 업무 종사자 |
Venue: TBD |
Time |
Title |
Instructor |
09:00-09:30 |
Registration |
|
09:30-10:15 |
Investigator’s Brochure Preparation (1) |
KS Kim |
10:15-10:30 |
Break |
|
10:30-11:15 |
Investigator’s Brochure Preparation (2) |
KS Kim |
11:15-11:30 |
Break |
|
11:30-12:30 |
Common Technical Document |
EJ Lee |
12:30-13:30 |
Lunch |
|
13:30-14:15 |
Clinical Trial Design Part I (1) |
YJ Chung |
14:15-14:30 |
Break |
|
14:30-15:15 |
Clinical Trial Design Part I (2) |
YJ Chung |
15:15-15:30 |
Break |
|
15:30-16:30 |
Clinical Trial Design Part II (1) |
BJ Ahn |
16:30-16:45 |
Break |
|
16:45-17:30 |
Clinical Trial Design Part II (2) |
BJ Ahn |
17:30-18:00 |
Wrap-up and Q&A |
|
Course Title: Medical Writing in Clinical Research Part 2 |
Presenters: Jeon, Jaeeun (Medical Part Manager) · Kim, Hyunjung (Medical Team Manager, MD) ·Cho, Minhee (Medical Part Manager) · Oh, Eunsook (Sr.Medical Writer[JE2] ) |
Participants: Medical Writing 업무를 하고 있는 분 또는 임상시험관련 업무 종사자 |
Venue: TBD |
Time |
Title |
Instructor |
09:00-09:30 |
Registration |
|
09:30-10:15 |
Clinical Trial Protocol Development (1) |
JE Jeon |
10:15-10:30 |
Break |
|
10:30-11:15 |
Clinical Trial Protocol Development (2) |
JE Jeon |
11:15-11:30 |
Break |
|
11:30-12:30 |
Literature Searching & Evaluation |
HJ Kim |
12:30-13:30 |
Lunch |
|
13:30-14:15 |
Clinical Study Report (1) |
MH Cho |
14:15-14:30 |
Break |
|
14:30-15:15 |
Clinical Study Report (2) |
MH Cho |
15:15-15:30 |
Break |
|
15:30-16:15 |
Good Design and Review Process (1) |
ES Oh |
16:15-16:30 |
Break |
|
16:30-17:30 |
Good Design and Review Process (2) |
ES Oh |
17:30-18:00 |
Test & Wrap-up |
|
구분 | 진도율 | 시험 | 과제 | 토론 | 총점 |
---|---|---|---|---|---|
평가비율(%) | - | 100 | - | - | 100% |
수료기준(점) | - | 60 | - | - | 60 |