-
Sale!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.
-
Get Certified Today!
Do you need an upgrade to MDR, MPDG and ISO 14155:2020 to your existing MPG certificate to continue or start your medical device trials? Would you like to deepen your knowledge? This Mastertrial MPDG/MDR update course is all online and is recognized by the Berlin Medical Association as CME continued education. Download the MDR/MPDG Update Course Brochure -
Get Certified Today!
Do you need an MPG certificate to carry out clinical trials with medical devices? Would you like to deepen your knowledge? This Mastertrial MPG/GCP course is all online and is recognized by the Berlin Medical Association (CME). This Refresher Course offers the following accredited training course for principal examiners, examiners and members of the examination group. Download the MPG courses brochure -
Get Certified Today!
Do you need an MPG certificate to carry out clinical trials with medical devices? Would you like to deepen your knowledge? This Mastertrial MPG/GCP course is all online and is recognized by the Berlin Medical Association (CME). This Basic Course offers the following accredited training course for principal examiners, examiners and members of the examination group. Download the MPG courses brochure -
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.
-
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).