| 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 |
Importance of Clinical Investigator´s Brochure (IB)
Importance of Clinical Investigator´s Brochure (IB)
This course focuses on clinical Investigator’s Brochures (IBs) and offers key insight into the importance of providing investigators with information supporting a medical device’s use in clinical investigations. This document, along with personal instructional training, directly impacts the establishment of trust and cooperation with investigators.
A large portion of this course is dedicated to detailing the type of content an IB must present to investigators. It covers the following topics:
- A discussion on the role of Instructions for Use (IFU) and product training
- The importance of protecting company intellectual property
- How risk management uses investigational device information and pre-clinical and clinical data to form compelling arguments regarding the safety of investigational devices
2 modules
€ 332.00
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