| 1 x | The Close Down Visit | € 108.00 |
| 1 x | Applying GDPR to Medical Devices Clinical Investigations | € 124.00 |
| 1 x | ISO 14155 - Risk Management | € 148.00 |
| 1 x | ISO 14155 - Ethical Condiseration | € 112.00 |
| 1 x | GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations (v3) | € 84.00 |
| 1 x | Overview of Data Management Plan and Query Process | € 81.00 |
| 1 x | GCP for Investigators: Clinical Investigation Close out or termination (v3) | € 66.00 |
| 1 x | The Periodic Monitoring Visit | € 429.00 |
Safety Reporting Requirements 2 course Suite v.3
Safety Reporting Requirements 2 course Suite v.3
This suite of 2 courses provides a review of the overall regulatory requirements in EU, US and JAPAN; which documents are applicable and what the different reporting requirements are for both competent authorities and ethics committees. This course will be updated constantly with individual National Competent Authority requirements.
v.3
ID: 79
51 minutes
2 trainings
€ 163.00
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| Course | ID | Duration | |
|---|---|---|---|
European Safety Reporting Requirements during Clinical Investigations v3 |
82 | 31 minutes | |
US Safety Reporting Requirements during Pre-Market Clinical Trials v3 |
90 | 20 minutes |
Learning Objectives
The learner will be able to distinguish the different reporting requirements throughout EU, US and Japan for adverse events during clinical investigations
Who Should Enroll
Primary BoK – related topic # Clinical Evaluation 1.19, 1.20, 1.22
Level of Primary BoK: CMDA
Geographic region: EU and USA
Secondary BoK (cross functional): Regulatory
Prerequisite Knowledge
A full understanding of the basics in adverse event reporting as outlined in the WMDO course ‘adverse event processes (ID 59) is required before taking the courses in this suite. It is also useful to understand the mechanisms of ethics committee or institutional review board communications as outlined in course ‘Ethics Committee and IRB requirements (ID 46)