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Courses tagged with "English"
Clinical Evaluation Upgrade to MDR
Clinical Evaluation 2020Time: 39 minutes
Is your Clinical Evaluation ready for the MDR? Discover Meditrial e-learning and avoid delays for market access. Meditrial will guide you with easy steps. Learn at your own pace and reach your goals!
After the course, you can take a brief test to receive your certification. Enjoy!
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.
Clinical Trial Information System (CTIS)
Clinical Trials
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.
Training on Meditrial Good Clinical Practice (GCP) procedures
Clinical TrialsLimited to Meditrial CRO Customers
Learn everything you need to know for a successful Clinical Trial Monitoring and Management, in accordance with the new ISO 14115:2019
Clinical Site Selection
Clinical TrialsLimited to Meditrial CRO Customers
Readiness for GCP Audit
Clinical TrialsDiscover Meditrial Academy’s course on how to get ready for a GCP audit. Learn from the experts how to prepare for the visit of an auditor to ensure your trial’s conformity to the protocol, procedures and regulation will be successfully confirmed.
Study Approval In EU Countries
Clinical TrialsLimited to Meditrial CRO Customers
Compassionate Use Approval Procedures
Clinical TrialsLimited to Meditrial CRO Customers
6. MDR ADVERSE EVENT REPORTING IN CLINICAL INVESTIGATIONS
Clinical Trials for Medical Devices in Europe
5. MDR SUBSTANTIAL STUDY CHANGES, TEMPORARY HALT AND TERMINATION
Clinical Trials for Medical Devices in Europe
4. MDR STUDY APPLICATION AND APPROVAL - NEW COORDINATED ASSESSMENT
Clinical Trials for Medical Devices in Europe
3. MDR CONDITIONS, ETHICAL PRINCIPLES, METHODS, INFORMED CONSENT
Clinical Trials for Medical Devices in Europe
Clinical Trials for Medical Devices in Europe - COMPLETE TRAINING PROGRAM
Clinical Trials for Medical Devices in Europe
1. MDR NEW DEFINITIONS AND TYPES OF TRIALS
Clinical Trials for Medical Devices in Europe
2. MDR THE ACTORS: SPONSOR, INVESTIGATOR & SUBJECT
Clinical Trials for Medical Devices in EuropeThis course presents an overview of the "actors" within the scope of the new MDR, namely the sponsors, investigators, and subjects. Learn all you need to know about how these "actors" play a significant role within the new MDR.
After the course, you can take a brief test to receive your certification. Enjoy!
INVESTIGATIONAL DEVICE EXEMPTION (IDE)
Clinical Trials in US
LEARN FOR FREE
This exclusive educational event is reserved to selected Meditrial customers and Meditrial’s staff. With COVID 19, medical device companies are facing increasing complexity to conduct their clinical trials in the US.
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.
COVID-19 PPE Emergency
Covid-19Time: 15 Minutes
Clinical Trials During COVID-19
Covid-19Video Course
Time: 22 Minutes
In the world today we need digital health. We will discuss what is the digital health revolution and in what way has Covid acted as the catalyzer. We will then get into what are the tools and technologies that are already out there today.
INTERVIEW
LEARN FOR FREEThe Digital Health landscape is rapidly expanding and innovating. In this webinar Peter Fitzgerald delivers an informative and interesting presentation of digital health in the COVID Age and forward.
The Digital Health landscape is rapidly expanding and innovating. In this webinar Peter Fitzgerald delivers an informative and interesting presentation of digital health in the COVID Age and forward.
Southern Europe Market Access
Europe Market AccessLevel: All Levels
Time: 15 Minutes
This tutorial intends to provide the requirements for placing CE-marked Medical Devices on the European market according to the Regulation (EU) 2017/745 on Medical Devices (MDR).
Eastern Europe Market Access
Europe Market AccessLevel: All Levels
Time: 15 minutes
This tutorial intends to provide the requirements for placing CE-marked Medical Devices on the European market according to the Regulation (EU) 2017/745 on Medical Devices (MDR).
Western Europe Market Access
Europe Market AccessLevel: All Levels
Time: 15 minutes
This tutorial intends to provide the requirements for placing CE-marked Medical Devices on the European market according to the Regulation (EU) 2017/745 on Medical Devices (MDR).
Northern Europe Market Access
Europe Market AccessLevel: All Levels
Time: 15 minutes
This tutorial intends to provide the requirements for placing CE-marked Medical Devices on the European market according to the Regulation (EU) 2017/745 on Medical Devices (MDR).
FDA IVD REGULATION
FDA Medical Device Regulation for Everyone
FDA EARLY FEASIBILITY STUDY PROGRAM
FDA Medical Device Regulation for EveryoneWe will provide insights concerning Early Feasibility Studies and FDA applicable requirements. We will guide you through the steps needed for a successful EFS submission despite challenges that may impact the process. Moreover, you will get recommendations on the submission process and helpful information.
510(k) Submission Process
FDA Medical Device Regulation for Everyone
FDA Q-Submission Process
FDA Medical Device Regulation for Everyone
Breakthrough Device Designation
FDA Medical Device Regulation for Everyone
Emergency Use Authorization (EUA)
FDA Medical Device Regulation for Everyone
De Novo Classification Pathway
FDA Medical Device Regulation for Everyone
FDA Clinical Laboratory Improvement Amendments (CLIA)
FDA Medical Device Regulation for Everyone
FDA Safer technology program (STeP)
FDA Medical Device Regulation for Everyone
FDA Premarket Approval (PMA)
FDA Medical Device Regulation for Everyone
FDA Medical Device Development Tools (MDDT) Program
FDA Medical Device Regulation for Everyone
Monitoring for Medical Devices in the US Essential FDA Guidelines
FDA Medical Device Regulation for Everyone
What is GDPR?
When is it applicable?
Fines for Non-Compliance
GDPR and Clinical Trials
How to comply, practical approach
GDPR Compliance
GDPRSLIDE-SHOW
Compliance with the new general data protection regulation (GDPR): the present course explains about EU General Data Protection Regulation (GDPR) issued by the European Parliament and the Council of the EU to strengthen and unify data protection for all
individuals within the EU. The processing of personal data related to EU subjects for the purpose of clinical trials falls within the scope of the GDPR.
INNOVATIONS IN GLOBAL CLINICAL TRIALS
ISO 14155:2020 GCP for Medical DevicesWEBINAR REPLAY
This webinar provides an overview of the innovations in clinical trials and provides practical suggestions on how to get ready now – as the standard is already effective and everyone is expected to comply!
ISO 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.
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.
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 Devices
ISO 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.
In Vitro Medical Device Regulation Roadmap (IVDR)
New In Vitro Device Regulation (IVDR)In this course, we will cover all the necessary regulatory references. We will discuss in details an article 56 of IVDR. Moreover, you will learn about general safety and performance requirements. We will also explain what is the performance evaluation and step by step we will guide you through its components. At the end, we will highlight your periodic deliverables so you will be aware on what and when needs to be updated.
IVDR ISO 20916:2019
New In Vitro Device Regulation (IVDR)
European IVDR Masterclass
New In Vitro Device Regulation (IVDR)
Welcome to this Video Course on Health Economics and Outcomes Research. How companies can apply health economics in the early stages of their product development, and why this has benefits for the business success. This course will cover some basic concepts to review the reimbursement system and define the role of health economics and outcomes research and will focus on how to incorporate health economics in the market access strategy.
MDR ROADMAP FOR YOUR CLINICAL TRIALS
New Medical Device Regulation (MDR)With the new Medical Device Regulation now in force as of 26 May 2021, Meditrial has organized this live event reserved for our customers and partners, to help you understand what changes impact you and manage the transition for ongoing and new clinical trials.
MDR Requirements for device labeling and implant card
New Medical Device Regulation (MDR)
MDR The New European UDI System (Part 2)
New Medical Device Regulation (MDR)
MDR The New European UDI System (Part 1)
New Medical Device Regulation (MDR)
INTRODUCTION TO MEDICAL DEVICE REGULATION ROADMAP & ORIENTATION
New Medical Device Regulation (MDR)This course presents an overview of the new European regulation for medical devices and provides key information regarding new changes within the MDR. Learn all you need to know for a successful transition to the new legislative framework.
After the course, you can take a brief test to receive your certification. Enjoy!
MDR EUDAMED The European Database for Medical Devices and IVDS
New Medical Device Regulation (MDR)This video course presents the European Database for Medical Device and in vitro diagnostic device and provides key information in order to become familiar with the new electronic system for data storage. Learn all you need to know regarding the new Electronic database system.
MDR FOR DUMMIES
New Medical Device Regulation (MDR)This lecture presents the new European regulation for medical devices and provides an easy to learn overview of all the key changes. Learn all you need to know for a successful transition to the new legislative framework.
Post-Market Clinical Follow-Up
New Medical Device Regulation (MDR)This lecture describes the key changes regarding post market clinical follow-up and what companies should do to meet their new obligations. After the course you can take a final test to receive your certification. Enjoy!
Post-Market Surveillance for Medical Devices in Europe
New Medical Device Regulation (MDR)Video Course
Time: 25 Minutes
This lecture describes the key changes regarding post market surveillance and what companies should do to meet their new obligations.
After the course you can take a final test to receive your certification. Enjoy!
Medical Device Regulation Roadmap And Orientation
New Medical Device Regulation (MDR)RECORDED LIVE LECTURE - Dr. M. Tocchi
Time: 58 minutes
This lecture presents the roadmap of the new European regulation for medical devices and provides an orientation to navigate all the key changes. Learn all you need to know for a successful transition to the new legislative framework.
After the course, you can take a brief test to receive your certification. Enjoy!
MDR Fundamentals
New Medical Device Regulation (MDR)Welcome to the Meditrial MDR Fundamentals. In three easy VIDEO-COURSES, you will learn all the essential information regarding the MDR changes and the new procedures for Clinical Evaluation and clinical trials, including a learning module on the new standard 14155. Get ready to learn all you need to know on the new European regulation for medical devices. After the courses, you can take a brief test to receive your certification. Enjoy!
New Medical Device Regulation (MDR) Master Class
New Medical Device Regulation (MDR)Access Meditrial Academy to learn quickly and easily the details of the new Medical Device Regulation (MDR) 745/2017. Everything you need to know about the MDR and how to apply it to devices and companies.
EUDRAVIGILANCE CERTIFIED TRAINING
PharmacovigilanceYou will understand the European regulation, familiarize with the general terms, and learn the mandatory data elements necessary for the electronic submission of safety information on medicinal products.
European Pharmacovigilance and Drug Safety Training
PharmacovigilanceIn response to the global need for training in pharmacovigilance and the regulation changes in Europe, Meditrial has developed a series of e-learning courses covering different aspects of the science of medicines safety.
Meditrial’s e-learning courses take a micro-learning approach, with short, concise lessons connected to clear learning objectives. Most courses are taught in English, with subtitles in English. Courses are also available in other languages such as German, Italian and Chinese. Upon completing a course, you will take a final test to receive a digital certificate that can be printed.
The broad collection of self-paced e-learning courses is suitable to health professionals with an interest in pharmacovigilance. Courses are made available free of charge to those working at pharmacovigilance centres or in the public sector (hospitals, pharmacies, academia etc.). For those working at for-profit organisations or companies (pharmaceutical companies, contract research organisations etc.), the courses will be made available for a fee. Please visit our e-learning platform to enrol and learn more about the course content.
Lesson 3 - Design and Conduct Clinical Trials for Transcatheter Occluders ISO 22679
Product Guidelines and StandardsVIDEO COURSE
Discover the world of innovation and medical standards made easy, learn about the brand new ISO 22679 draft standard for cardiac occluders.CERTIFIED TRAINING
Lesson 2 - Device Design, Pre-Clinical Testing and Risk MGT
Product Guidelines and StandardsVIDEO COURSE
Discover the world of innovation and medical standards made easy, learn about the brand new ISO 22679 draft standard for cardiac occluders.CERTIFIED TRAINING
Lesson 1 - Introduction to ISO 22679
Product Guidelines and StandardsVIDEO COURSE
Discover the world of innovation and medical standards made easy, learn about the brand new ISO 22679 draft standard for cardiac occluders.CERTIFIED TRAINING
Transcatheter Cardiac Occluders - ISO 22679 - Complete course
Product Guidelines and StandardsVIDEO COURSE
Discover the world of innovation and medical standards made easy, learn about the brand new ISO 22679 draft standard for cardiac occluders.CERTIFIED TRAINING
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.
Startup Governance: A 10-Step Guide for innovators and board members
Startup and Business PracticesHow to run a startup successfully? The success of your business depends on the mix of innovative ideas and skilled board members. This video course will offer you a 10-Step Guide to quickly understand what you need to do to accomplish your goals and achieve the business targets for your MedTech company.
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!
NEW REQUIREMENTS FOR SAFETY REPORTING DURING CLINICAL INVESTIGATIONS
Meditrial EnterpriseThis course highlights new safety reporting obligations introduced by the Medical Device Regulation.
This course includes selected guides of Catchtrial eTMF and ISF training program, for MOCA I CorFlow.
By reading the course documentation, the User will be able to access and review eTMF documents stored in Egnyte and understand the structure of the ISF.
At the end of the course, a quiz made of #5 questions is available. Upon successfully answering at least #4 of the #5 questions, the User will get the training certificate.
Welcome to CorFlow MOCA I - eCRF Training for CRA, a guide for training study Monitors on Catchtrial EDC features implemented for MOCA I data capture and images transfer.
By reading the course documentation, the Monitor will be able to access and review the eCRF data, manage system queries (manual an automated), perform electronic Source Data Verification, lock the verified clinical data.
This course includes a final quiz made of #5 questions. Upon successfully answering at least #4 of the #5 questions, the Monitor will get the training certificate.
