Europe
Courses tagged with "Europe"
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!
Clinical Site Selection
Clinical TrialsLimited to Meditrial CRO Customers
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!
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.
LEARN FOR FREE
Stiamo attraversando la fase 2, ma la fase 3, la fase della Consapevolezza della Nuova Normalità, sarà quella decisiva per molti aspetti, per il lavoro, l'economia, la salvaguardia della salute,
la sicurezza. Inizia a farsi chiaro che sono e saranno molteplici le insidie nell'ambito della mental health che i nuovi scenari stanno già sollecitando oggi. Parleremo di come prepararci ad affrontare questa fase.
COVID-19 PPE Emergency
Covid-19Time: 15 Minutes
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 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.
MDR/MPDG Update Course - Online
Medical Device Clinical Trials in Germany - MPG CME Certified CoursesDer Update-Kurs richtet sich an Hauptprüfer, Prüfärzte und Studienpersonal in klinischen Prüfungen, die ein gültiges MPG-Zertifikat besitzen und die Teilnahme an klinischen Prüfungen unter der neuen EU-Medizinprodukteverordnung und der ISO 14155:2020 beginnen oder fortsetzen wollen.
Der Schwerpunkt des Kurses liegt darin, Sie mit den wichtigsten Änderungen, die sich mit Einführung der EU-Verordnung 2017/745, dem MPDG und der ISO 14155:2020 ergeben, vertraut zu machen.
MPG Auffrischungskurs - Onlinekurs
Medical Device Clinical Trials in Germany - MPG CME Certified CoursesDer Auffrischungskurs richtet sich an Hauptprüfer und Prüfer bei klinischen Prüfungen, die bereits einen MPG Grundlagenkurs absolviert haben, jedoch über einen Zeitraum von drei Jahren keine aktive Beteiligung an klinschen Prüfungen nachweisen können.
Inhouse-Schulungen oder Live-Webinar auf Anfrage.
Sind Sie interessiert?
10. Privacy, GDPR e Medical Device
Medical Device RevolutionMeditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
9. ITALIA: Normative e Procedure di approvazione, gestione centri, monitoraggio e report di sicurezza
Medical Device RevolutionMeditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
8. Digital Health, eCRF/ePRO, Data Management, Cybersecurity
Medical Device RevolutionMeditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
7. ISO 14155: il monitoraggio per i Medical Device in pratica
Medical Device RevolutionMeditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
6. ISO 14155 Conduzione dello studio dalla A alla Z
Medical Device RevolutionMeditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
5. ISO 14155 Fondamenti, Disegno e pianificazione dello studio, la documentazione
Medical Device RevolutionMeditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
4. EUROPA i Trial Clinici, le nuove regole, cosa cambia e come prepararsi
Medical Device RevolutionMeditrial presenta un corso di alta formazione in ricerca clinica sui dispositivi medici: Medical Device Revolution promosso da Formazione del Farmaceutico.
Con la nuova Normativa MDR il mondo dello sviluppo clinico dei dispositivi medici subirà una rivoluzione! Con il Corso "Medical Device Revolution" vogliamo aiutarti ad affrontare questa rivoluzione in maniera più consapevole.
Il corso è coordinato dalla Dott.ssa Monica Tocchi, CMO e Founder della CRO Meditrial, coinvolta in prima persona nel panel di esperti che hanno aggiornato la ISO 14155:2020.
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.
European IVDR Masterclass
New In Vitro Device Regulation (IVDR)
Medical Device Day
New Medical Device Regulation (MDR)L’Università degli Studi di Roma Tre e Meditrial presentano una giornata dedicata al mondo dei Medical Device all’interno del Master Sociosanitario. Le testimonianze di esperti, protagonisti nel settore sanitario, socio-sanitario e socio-educativo, racconteranno l’evoluzione del panorama globale in ambito MDR a livello clinico e regolatorio.
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.
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.
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!
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.
The Pharmacovigilance System in Europe - Chinese
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.
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
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.
