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Basics of Clinical Regulatory Writing

FREE

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Course Overview

Schedule of Classes

Course Curriculum

1 Subject

Clinical Regulatory Writing

19 Learning Materials

Introduction to Clinical Regulatory Writing

Introduction to Clinical Regulatory Writing

Video
00:13:30
FREE

Essential Clinical Study Documents and Trackers in CRW

Essential Clinical Study Documents and Trackers in CRW

Video
00:15:30

Overview of Clinical Study Report

Overview of Clinical Study Report

Video
00:06:33

Clinical Study Report (CSR) Writing

Clinical Study Report (CSR) Writing

Video
00:21:50

MDR

MDR 1

Video
01:12:40

MDR 2

Video
00:21:13

Safety Reporting

Safety Reporting

Video
00:14:48

Summary of Safety and Effectiveness Data (SSED)

Summary of Safety and Effectiveness Data (SSED)

Video
00:14:12

ISO Standards for Medical Devices

ISO Standards for Medical Devices

Video
00:16:47

ICH GCP E3:1995 vs ISO 14155:2020 vs MDCG 2021-6

ICH GCP E31995 vs ISO 141552020 vs MDCG 2021-6

Video
00:14:16

MedDRA CODING

MedDRA CODING

Video
00:14:02

Clinical Trials Registration and Reporting

Clinical Trials Registration and Reporting

Video
00:29:14

MDCG Rules 2021-24 Guidance on Classification of Medical Devices

Part 1

Video
00:29:55

Part 2

Video
00:21:44

FDA Regulatory and Clinical Submission Pathways for Medical Devices

13A

Video
00:33:45

13B

Video
00:28:25

13C

Video
00:22:02

MHRA Clinical Investigation of Medical Devices

MHRA Clinical Investigation of Medical Devices

Video
00:32:27

SUBJECT EXPERT COMMITTEES (SECs)

SUBJECT EXPERT COMMITTEES (SECs)

Video
00:12:50

Course Instructor