교육관리시스템

Application

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Multi-Regional Clinical Trials(MRCT) and Good Clinical Practice(GCP) Inspection

Classification	Online education
Category	KIC_eng. > Level 6
Name	Multi-Regional Clinical Trials(MRCT) and Good Clinical Practice(GCP) Inspection
Application period	2021.08.25 (09:00) ~ 2021.09.17 (24:00)	Education period	2021.10.03 ~ 2021.10.31
Days/hour	7 days / 9 hours	Place	Virtual
Education fee	free	Capacity	No personnel limit

Introduction
Table of contents
Education schedule

Overview of Learning

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AGENDA 1 (On-line)

AGENDA 2 (Live Session)

Tutor

1.Ni Aye Khin
2.Dong Ho Kim Pietsch
3.Jason Wakelin-Smith
4.Jun Li
5.Annette Gross
6.Yuki Ando
7.Cheryl Grandinetti
8.Julia Cho

Pass/fail criteria

Evaluation criteria	Attendance rate	Online progress rate	Test	Task	Discussion	Others
Percentage in evaluation	-	100.00%	-	-	-	-
Minimum requirement	-	4%	-	-	-	-

No.	Classification	Name of Lecture	Study period	Hours
1	Online/Lecture	Basics of GCP Inspection	2021-10-03 09:30 ~ 2021-10-24 23:50	43minute
2	Online/Lecture	Planning & Preparation of GCP Inspection	2021-10-03 09:30 ~ 2021-10-24 23:50	1hours 14minute
3	Online/Lecture	Conducting GCP Inspection	2021-10-03 09:30 ~ 2021-10-24 23:50	53minute
4	Online/Lecture	Evaluation of GCP Inspection	2021-10-03 09:30 ~ 2021-10-24 23:50	46minute
5	Online/Lecture	Quality & Compliance in Decentralised Clinical Trials	2021-10-03 09:30 ~ 2021-10-24 23:50	56minute
6	Online/Lecture	MRCT and ICH E17: Ethnic sensitivity and pooling strategy considerations	2021-10-03 09:30 ~ 2021-10-24 23:50	52minute
7	Online/Lecture	Assessment of Marketing Authorization Application with MRCT	2021-10-03 09:30 ~ 2021-10-24 23:50	46minute
8	Online/Lecture	eSystems Used in Clinical Trials: Are They Fit for Purpose?	2021-10-03 09:30 ~ 2021-10-24 23:50	32minute
9	Online/Lecture	FDA Bioavailability/Bioequivalence Inspection	2021-10-03 09:30 ~ 2021-10-24 23:50	44minute
10	Online/Questionnaire	Multi-Regional Clinical Trials(MRCT) and Good Clinical Practice(GCP) Inspection_Survey	2021-10-03 09:00 ~ 2021-10-31 23:50	-

Date	Time	Title of Lecture
10/ 03	09:00-18:00	Basics of GCP Inspection
10/ 03	09:00-18:00	Planning & Preparation of GCP Inspection
10/ 03	09:00-18:00	Conducting GCP Inspection
10/ 03	09:00-18:00	Evaluation of GCP Inspection
10/ 03	09:00-18:00	Quality & Compliance in Decentralised Clinical Trials
10/ 03	09:00-18:00	MRCT and ICH E17: Ethnic sensitivity and pooling strategy considerations
10/ 03	09:00-18:00	Assessment of Marketing Authorization Application with MRCT
10/ 03	09:00-18:00	eSystems Used in Clinical Trials: Are They Fit for Purpose?
10/ 03	09:00-18:00	FDA Bioavailability/Bioequivalence Inspection

국가임상시험지원재단

KAC, 6th floor of the 137 KPX Building, Mapo-daero, Mapo-gu, Seoul, Republic of Korea / Business Registration Number: 110-82-17935 / Director: Inseok Park
Education 02-398-5090, 02-398-5036, 02-398-5093, 02-398-5094
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