| 1 x | Clinical Evaluation Report: Review for Regulatory Professionals | € 308.00 |
| 1 x | GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations | € 84.00 |
| 1 x | ISO 14155_课程1_范围 | € 143.00 |
| 1 x | test training for stg env | € 12.00 |
| 1 x | second video test | € 9.00 |
| 1 x | 临床试验的启动 | € 95.00 |
| 1 x | 临床试验关闭或终止 | € 66.00 |
| 1 x | US Safety Reporting Requirements during Pre-Market Clinical Trials | € 72.00 |
| 1 x | Duplicate of wmdos-34 | € 20.00 |
| 1 x | GCP for Investigators: Clinical Investigation Close out or Termination | € 66.00 |
| 1 x | Clinical Evaluation for Market Approval | € 616.00 |
| 1 x | GCP for Investigators: How to Qualify for Medical Device Clinical Investigations | € 95.00 |
| 1 x | GCP for Investigators: Introduction to Medical Devices | € 126.00 |
| 1 x | Managing Data Release Consent During Post Market Studies | € 75.00 |
| 1 x | European Safety Reporting Requirements during Clinical Investigations | € 90.00 |
| 1 x | Medical Device GCP for Investigators | € 120.00 |
| 1 x | Understanding Clinical Evaluation for Notified Body and Regulatory Professionals | € 544.00 |
| 1 x | GCP for Investigators: Initiation of a Medical Device Clinical Investigation | € 95.00 |
| 1 x | ISO 14155_课程3_临床试验策划 | € 180.00 |
| 1 x | ISO 14155_课程4_临床试验的开展 | € 143.00 |
| 1 x | Medical Device GCP – Investigator Certificate | € 255.00 |
| 1 x | ISO 14155_课程5_临床试验关闭 | € 90.00 |
| 1 x | Importance of Clinical Investigator´s Brochure (IB) | € 332.00 |
| 1 x | with video | € 22.00 |
| 1 x | Applying GDPR to Medical Devices Clinical Investigations | € 124.00 |
| 1 x | The European Medical Device New Regulation 2017/745 | € 925.00 |
| 1 x | with video /2222 | € 15.00 |
| 1 x | ISO 14155 GCP – Main Differences with ICH 6 clinical professionals should know | € 161.00 |
| 1 x | ISO 14155_课程7_主要研究者职责 | € 125.00 |
| 1 x | GCP for Investigators: Clinical Investigation Conduct and Reporting | € 128.00 |
| 1 x | 课程1：医疗器械简介 | € 120.00 |
| 1 x | wmdos-34 | € 20.00 |
| 1 x | Clinical Evaluation for Market Approval | € 352.00 |
| 1 x | 如何进行医疗器械临床试验相关资质评估 | € 95.00 |
| 1 x | Source Document Verification | € 108.00 |
| 1 x | The Close Down Visit | € 108.00 |
| 1 x | ISO 14155:2020 - Ethical Considerations | € 108.00 |
| 1 x | The Case Report Form Process | € 161.00 |
| 1 x | The Clinical Investigation Plan | € 161.00 |
| 1 x | ISO 14155:2020 - Clinical Investigation Close Out | € 90.00 |
| 1 x | ISO 14155:2020 - Certificate | € 580.00 |
| 1 x | Introduction to Good Clinical Practice | € 109.00 |
| 1 x | ISO 14155:2020 - Clinical Investigation Planning | € 180.00 |
| 1 x | Device Accountability | € 72.00 |
| 1 x | The Informed Consent Process | € 161.00 |
| 1 x | ISO 14155:2020 - Clinical Investigation Conduct | € 143.00 |
| 1 x | Adverse Event Processes | € 275.00 |
| 1 x | Ethics Committee(EC) / Institutional Review Board Requirements | € 143.00 |
Adverse Event Processes
Adverse Event Processes
This course provides a detailed review of the basics and fundamentals of safety reporting during clinical investigations prior to market approval. It outlines the entire process, using practical examples and flowcharts to illustrate each mechanism of the safety processes step-by-step.
This course covers the following topics:
- Objectives of safety reporting
- Definitions of the different classifications of adverse events and device deficiencies according to ISO 14155: 2011 principles
- Roles and responsibilities of the following parties: sponsors, monitors, investigators and their teams, critical event committees, and data monitoring boards
- Reporting obligations of each party
- Summary of the national differences in safety reporting, i.e. the US, Europe, and Japan
- Type of reports
- Examples and exercises of common errors
- Case studies of several real-life situations and step-by-step guidance on what to do as a monitor or sponsor
2 modules
€ 275.00
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