| 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 |
课程1：医疗器械简介
课程1：医疗器械简介
本次课程阐述了医疗器械GCP 的基本信息和背景
本次课程内容包括：
- 基本要点概述
- 在欧洲和美国的医疗器械法规环境概述
- 赫尔辛基宣言如何应用于医疗器械领域
- 相关的GCP 法规文件
- ICH E6 GCP 与ISO 14155 GCP 的主要区别
- 开展临床试验必要的生产流程
- 简述医疗器械研究设计要点
本次课程内容根据：
- ISO 14155:2011版：应用于人类受试者的医疗器械临床试验
- 赫尔辛基宣言
- 21 CFR 812：试验用器械豁免
- 21 CFR 50：人类受试者的保护
观看课程预告
2 modules
€ 120.00
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