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.
Good Clinical Practice for Drugs and Medical Devices
Clinical TrialsTime: 15 Minutes
This lecture describes covers the basic concepts that are important to understand in clinical research for different medical products.
Quality Management System for Medical Devices and Clinical Trials
Clinical Trials in USThis 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.
Clinical Trials During COVID-19
Covid-19Video Course
Time: 22 Minutes
FDA Medical Device Development Tools (MDDT) Program
FDA Medical Device Regulation for EveryoneMonitoring for Medical Devices in the US Essential FDA Guidelines
FDA Medical Device Regulation for EveryoneISO 14155 2020 Safety and Adverse Events
ISO 14155:2020 GCP for Medical DevicesThis 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.
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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.
ISO 14155 2020 Overview
ISO 14155:2020 GCP for Medical DevicesTime: 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.
ISO 14155 2020 New Responsibilities of Sponsor/CRO
ISO 14155:2020 GCP for Medical DevicesLevel: Intermediate
Time: 20 Minutes
This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for sponsor and CRO responsibilities.
ISO 14155 2020 Responsibilities of Principal Investigator
ISO 14155:2020 GCP for Medical DevicesLevel: Intermediate
Time: 20 Minutes
This tutorial provides an accurate overview of the main changes introduced by ISO 14155:2020 for principal investigator responsibilities
ISO 14155 2020 Masterclass
ISO 14155:2020 GCP for Medical DevicesISO 14155 2020 Ethical Considerations
ISO 14155:2020 GCP for Medical DevicesThis tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for Ethics and the informed consent process.
ISO 14155 2020 Clinical Trial From Start To Finish
ISO 14155:2020 GCP for Medical DevicesLevel: 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.
INNOVAZIONE NEL MONDO DELLA RICERCA CLINICA
New Medical Device Regulation (MDR)Fastrack to Success: How to Build a Regulatory and Clinical Strategy
Startup and Business PracticesThe 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.
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!