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.
Clinical Trials for Medical Devices in Europe – Complete Training Program
- Course Type: Video Lessons
- Language: English
- Level: Intermediate
- Session: year 2020
- Time: 1 - 3 Hours
- Special: BUNDLE & SAVE!
- MDR New Definitions and Types of Trials
- MDR The Actors: Sponsor, Investigator & Subject
- MDR Conditions, Ethical Principals, Methods, Informed Consent
- MDR Study Application and Approval – New Coordinated Assessment
- MDR Substantial Study Changes, Temporary Halt and Termination
- MDR Adverse Event Reporting in Clinical Investigations
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