Intermediate
Courses tagged with "Intermediate"
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.
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.
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
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!
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 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.
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.
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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.
3. EUROPA Nuovo Regolamento: panoramica e punti critici per le CRO
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.
2. Orizzonti del Medical Device, Regolamenti Globali, Roadmap to Market
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.
1. Il mondo del medtech, biotech e digital health - capire la classificazione e il mercato
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.
IVDR ISO 20916:2019
New In Vitro Device Regulation (IVDR)
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.
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!
INNOVAZIONE NEL MONDO DELLA RICERCA CLINICA
New Medical Device Regulation (MDR)
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.
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.
