6. MDR ADVERSE EVENT REPORTING IN CLINICAL INVESTIGATIONS
Clinical Trials for Medical Devices in EuropeDuration: Unlimited
Cost: 179 USD
The purpose of this tutorial is to analyze the MDR provisions for adverse events recording and reporting to Competent Authorities. The topics addressed are: MDR references, Relevant definitions, Sponsor obligations in case of adverse events occurring
during the clinical investigation and Regulatory comparison: MDD vs MDR.
Length: 00:15
5. MDR SUBSTANTIAL STUDY CHANGES, TEMPORARY HALT AND TERMINATION
Clinical Trials for Medical Devices in EuropeDuration: Unlimited
Cost: 179 USD
This tutorial aims to provide an overview of the MDR provisions related to the end of the clinical investigation, along with an outline of the MDR rules concerning the extraordinary events which could happen during the clinical investigation (substantial
modifications, corrective measures, temporary halt, early termination).
Length: 00:15
4. MDR STUDY APPLICATION AND APPROVAL - NEW COORDINATED ASSESSMENT
Clinical Trials for Medical Devices in EuropeDuration: Unlimited
Cost: 179 USD
Learn the new MDR rules for study application and approval process. The coordinated assessment procedure will streamline clinical investigations conducted in more than one EU Members State.
Length: 00:20
3. MDR CONDITIONS, ETHICAL PRINCIPLES, METHODS, INFORMED CONSENT
Clinical Trials for Medical Devices in EuropeDuration: Unlimited
Cost: 179 USD
This lecture investigates the new Medical Device Regulation (MDR) with regard to conditions, ethical principles, methods and informed consent process. The intent of this tutorial is to describe the conditions for carrying out clinical investigations and
to outline the rules laid down by MDR for particular clinical investigation types.
Length: 00:20
Clinical Trials for Medical Devices in Europe - COMPLETE TRAINING PROGRAM
Clinical Trials for Medical Devices in EuropeDuration: Unlimited
Cost: 1074 USD
This course will help you to discover new definitions and types of trials as well as the main actors involved, specifically sponsor, investigator and subject. You will also learn about conditions, ethical principles, methods and the informed consent process and develop a better understanding of the new coordinated assessment. You will also gain key knowledge regarding substantial changes, temporary halt, and termination as well as adverse event reporting.
Length: 02:00
1. MDR NEW DEFINITIONS AND TYPES OF TRIALS
Clinical Trials for Medical Devices in EuropeDuration: Unlimited
Cost: 179 USD
Learn the new definitions and types of trials contained in the MDR, understand when investigations are not required and much more.
Length: 00:20
2. MDR THE ACTORS: SPONSOR, INVESTIGATOR & SUBJECT
Clinical Trials for Medical Devices in EuropeDuration: Unlimited
Cost: 179 USD
This 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!
Length: 00:15