Online Course Catalogue

Change Currency:
€ EUR$ USD¥ JPY

Clinical Evaluation

Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Importance of Clinical Investigator´s Brochure (IB) 11785 mins€ 332.00€ 249.00
ISO 14155:2020 – A Summary Review 14480 mins€ 286.00€ 215.00
Managing Data Release Consent During Post Market Studies 22631 mins€ 75.00€ 56.00
ISO 14155 GCP – Main Differences with ICH 6 clinical professionals should know N32545 mins€ 161.00€ 121.00
Safety Reporting Requirements 2 course Suite
US Safety Reporting Requirements during Pre-Market Clinical Trials 9020 mins€ 72.00€ 54.00
European Safety Reporting Requirements during Clinical Investigations 8225 mins€ 90.00€ 68.00
Medical Device GCP for Investigators
GCP for Investigators: Introduction to Medical Devices 19352 mins€ 126.00€ 95.00
GCP for Investigators: How to Qualify for Medical Device Clinical Investigations 20032 mins€ 95.00€ 72.00
GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations 21225 mins€ 84.00€ 63.00
GCP for Investigators: Initiation of a Medical Device Clinical Investigation 20230 mins€ 95.00€ 72.00
GCP for Investigators: Clinical Investigation Conduct and Reporting 20451 mins€ 128.00€ 96.00
GCP for Investigators: Clinical Investigation Close out or Termination 20623 mins€ 66.00€ 50.00
Effective Monitoring of Medical Device Clinical Investigations
History of Good Clinical Practice (GCP) 4115 minsFREEFREE
Introduction to Good Clinical Practice 4245 mins€ 109.00€ 82.00
Introduction to Medical Device and Clinical Investigation Planning 4345 mins€ 161.00€ 121.00
The Clinical Investigation Plan 4445 mins€ 161.00€ 121.00
The Informed Consent Process 4545 mins€ 161.00€ 121.00
Ethics Committee(EC) / Institutional Review Board Requirements 4640 mins€ 143.00€ 108.00
Selecting Investigation Sites 4745 mins€ 161.00€ 121.00
Initiation Visit 4845 mins€ 161.00€ 121.00
Adverse Event Processes 5977 mins€ 275.00€ 207.00
The Periodic Monitoring Visit 56120 mins€ 429.00€ 322.00
Device Accountability 5020 mins€ 72.00€ 54.00
Deviations and Non-Compliance Handling 5115 mins€ 54.00€ 41.00
Source Document Verification 5230 mins€ 108.00€ 81.00
The Case Report Form Process 5345 mins€ 161.00€ 121.00
Visit Report Writing 5415 mins€ 54.00€ 41.00
The Close Down Visit 5530 mins€ 108.00€ 81.00
ISO 14155:2020 - GCP Certificate
ISO 14155:2020 - Scope N15840 mins€ 143.00€ 108.00
ISO 14155:2020 - Ethical Considerations N17530 mins€ 108.00€ 81.00
ISO 14155:2020 - Clinical Investigation Planning N17650 mins€ 180.00€ 135.00
ISO 14155:2020 - Clinical Investigation Conduct N17740 mins€ 143.00€ 108.00
ISO 14155:2020 - Clinical Investigation Close Out N17825 mins€ 90.00€ 68.00
ISO 14155:2020 - Responsibilities of Sponsor N18445 mins€ 161.00€ 121.00
ISO 14155:2020 - Responsibilities of Principal Investigator N18535 mins€ 125.00€ 94.00
ISO 14155:2020: 综述
ISO 14155_课程1_范围 N21340 mins€ 143.00€ 108.00
ISO 14155_课程2_伦理和知情同意 N21430 mins€ 108.00€ 81.00
ISO 14155_课程3_临床试验策划 N21550 mins€ 180.00€ 135.00
ISO 14155_课程4_临床试验的开展 N21640 mins€ 143.00€ 108.00
ISO 14155_课程5_临床试验关闭 N21725 mins€ 90.00€ 68.00
ISO 14155_课程6_申办方职责 N21845 mins€ 161.00€ 121.00
ISO 14155_课程7_主要研究者职责 N21935 mins€ 125.00€ 94.00
医疗器械GCP_研究者篇
课程1:医疗器械简介 N20552 mins€ 120.00€ 90.00
如何进行医疗器械临床试验相关资质评估 N20632 mins€ 95.00€ 72.00
医疗器械临床试验伦理和合法流程 N20925 mins€ 84.00€ 63.00
临床试验的启动 N20730 mins€ 95.00€ 72.00
临床试验开展与报告 N21051 mins€ 128.00€ 96.00
临床试验关闭或终止 N20823 mins€ 66.00€ 50.00

Clinical Evaluation

Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Applying GDPR to Medical Devices Clinical Investigations N24637 mins€ 124.00€ 94.00
EU-MDR 2017/745 Review for Clinical Professionals N24980 mins€ 234.00€ 176.00
Clinical Evaluation for Market Approval
Clinical Evaluation for Market Approval 11680 mins€ 352.00€ 264.00

Regulatory Affairs

Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
The European Medical Device New Regulation 2017/745 N180330 mins€ 925.00€ 694.00

Regulatory Affairs

Course Title Click on a title to view course descriptionIDDurationBasicPremiumPurchase
Understanding Clinical Evaluation for Notified Body and Regulatory Professionals
Clinical Evaluation Report: Review for Regulatory Professionals 10770 mins€ 308.00€ 231.00