Global

Courses tagged with "Global"

Scientific Discussion on the treatment of refractory angina. 

Dr. Konigstein presents the results of the latest publication on a novel treatment for this challenging clinical problem.

Category: Clinical Trials
Length: 00:40
Duration:  Unlimited
Cost:  49  USD

Video Course
Time: 15 Minutes

This lecture describes covers the basic concepts that are important to understand in clinical research for different medical products. 
After the course you can take a final test to receive your certification. Enjoy!

Category: Clinical Trials
Duration:  Unlimited
Cost:  49  USD

This recorded lecture, given by Charisse Green, Global Quality Expert, will help you discover the fundamental concepts of global quality for medical devices and clinical trials. She brings to you her professional perspective which stems from her extensive background as an FDA inspector.

Length: 00:20
Duration:  Unlimited
Cost:  49  USD

Video Course
Time: 22 Minutes

This video lecture discusses the impact of COVID-19 on clinical trials,  potential pathways and modifications needed to run a successful trial and how new technologies can assist in moving forward. 

Category: Covid-19
Length: 00:20
Version: 01
Release Date: 21 May 2020

FDA Medical Device Development Tools (MDDT) Program

FDA Medical Device Regulation for Everyone
Duration:  Unlimited
Cost:  49  USD
This recorded lecture, given by Charisse Green, Global Quality Expert, will help you discover the Medical Device Development Tools Program, this program is a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices.
Length: 00:20
Duration:  Unlimited
Cost:  49  USD
This recorded lecture, given by Charisse Green, Global Quality Expert, will help you discover the monitoring essential guidelines for medical devices in the US. She brings to you her professional perspective which stems from her extensive background as an FDA inspector.
Length: 00:10

ISO 14155 2020 Safety and Adverse Events

ISO 14155:2020 GCP for Medical Devices
Duration:  Unlimited
Cost:  99  USD

This lecture describes the key changes in the international ISO standard for clinical trials. In this module we will show you the main changes that have occurred compared to the ISO 14155 2011 in the safety and adverse event reporting.

Length: 00:15

New ISO 14155 2020 Key Changes for your Trial

ISO 14155:2020 GCP for Medical Devices

LEARN FOR FREE
RECORDED LIVE LECTURE - Dr. M. Tocchi
Time: 15 Minutes

This recorded video-lecture by Dr. Monica Tocchi, who contributed to the development of international standard ISO 14155 for clinical trials. This introductory course describes the key changes that affect pre-market studies and post-market trials for medical devices.

Length: 00:15
Version: 01
Release Date: 16 February 2020

ISO 14155 2020 Overview

ISO 14155:2020 GCP for Medical Devices
Duration:  Unlimited
Cost:  49  USD
VIDEO LECTURE
Time: 15 minutes

MDR is finally here and takes effect in May 2020! This video lecture provides you with an overview of the new regulations and clinical responsibilities set forth by the new ISO 14155 2020.
Length: 00:15
Version: 01
Release Date: 2 June 2020

ISO 14155 2020 New Responsibilities of Sponsor/CRO

ISO 14155:2020 GCP for Medical Devices
Duration:  Unlimited
Cost:  99  USD
VIDEO LECTURE
Level: Intermediate 
Time: 20 Minutes

This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for sponsor and CRO responsibilities.
Length: 00:20
Version: 01
Release Date: 20 April 2020

ISO 14155 2020 Responsibilities of Principal Investigator

ISO 14155:2020 GCP for Medical Devices
Duration:  Unlimited
Cost:  99  USD
VIDEO LECTURE
Level: Intermediate 
Time: 20 Minutes

This tutorial provides an accurate overview of the main changes introduced by ISO 14155:2020 for principal investigator responsibilities
Length: 00:20
Version: 01
Release Date: 1 April 2020

ISO 14155 2020 Masterclass

ISO 14155:2020 GCP for Medical Devices
Duration:  Unlimited
Cost:  495  USD
The ISO 14155 standard provides crucial guidance and support to any party involved in a clinical investigation - primarily to Sponsors (including monitors) and investigators, but also ethics committees, regulatory authorities and notified bodies implicated in the conformity assessment of medical devices.
Length: 02:00
Version: 01
Release Date: 20 April 2020

ISO 14155 2020 Ethical Considerations

ISO 14155:2020 GCP for Medical Devices
Duration:  Unlimited
Cost:  99  USD

This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for Ethics and the informed consent process.

Length: 00:20
Version: 01
Release Date: 12 April 2020

ISO 14155 2020 Clinical Trial From Start To Finish

ISO 14155:2020 GCP for Medical Devices
Duration:  Unlimited
Cost:  99  USD
VIDEO LECTURE
Level: Intermediate 
Time: 35 Minutes

This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for the Clinical Trial process. The clinical trial’s process is described from the beginning to the end: Planning, Conduct and Closeout. 
Length: 00:35
Version: 01
Release Date: 30 March 2020

INNOVAZIONE NEL MONDO DELLA RICERCA CLINICA

New Medical Device Regulation (MDR)
Duration:  Unlimited
Cost:  49  USD
Il mondo della ricerca clinica sui Medical Device sta subendo in questi anni una forte evoluzione dovuta all'incremento degli standard di qualità che in tempi brevissimi dovranno raggiungere il livello delle sperimentazioni con farmaco. Per questo motivo è fondamentale per chi lavora in questo ambito, ma anche per chi vuole ampliare le proprie prospettive, conoscere quali saranno gli scenari futuri dovuti a questa rivoluzione.

The goal of this presentation is to provide you with the essential elements for success and to teach you how to apply the information to your project.

Navigating the regulatory process and planning clinical trials can be the most daunting aspect of running your start-up.

Win KOLs and work with Partners

Startup and Business Practices
LEARN FOR FREE

What is a KOL? How to approach him? And, most importantly, how can he foster your business? This video course will provide you with insights about the world of KOLs and influencers in the Medtech and healthcare industry. Moreover, you will find out how KOLs can support the medtech development process and drive success of your company!

Length: 00:45
Version: 01
Release Date: 3 June 2020