MDR Academy: A guide to clinical studies and clinical investigations
Course Details
- Course Duration: 8 hours
- Target Audience: Representatives of pharmaceutical companies, project managers, regulatory specialists, medical advisors, scientific researchers
- Course Dates: Dates for 2025 have not yet been announced
- Course Fee (excl. VAT): CZK 7,500 per person
- Course Time and Venue: 08:30 – 17:30 at the company headquarters – Poštovská 3, Brno
The course will take place if at least 3 participants register. If the minimum number is not met, we will inform registered participants about the course cancellation three weeks prior to the planned start date.
Course introduction
Requirements for clinical studies/investigations under MDR? No stress! Join the MDR Academy and see that it’s absolutely doable – effectively and with ease.
Do you want to understand the current European regulations on medical devices (MDR)? Our academy will prepare you for conducting clinical studies, post-market clinical follow-up (PMCF), and compiling the necessary documentation.
Course objective
The goal of the course “MDR Academy: A Guide to Clinical Studies and Clinical Investigations” is to introduce participants to the current requirements of the European Medical Device Regulation (MDR 2017/745) and related standards (ISO 14155), and to help them understand these regulations.
This course is intended for healthcare professionals involved in clinical evaluation of medical devices and post-market activities: clinical study coordinators, regulatory specialists, representatives of pharmaceutical and biotech companies, and others.
The program of this intensive academy is structured into three modules that combine theory with practical insights.
At the beginning of the course, participants will be introduced to the essentials of planning a clinical investigation/study, including defining objectives and study design. The academy then focuses on the conduct and management of the clinical investigation, where participants will learn how to manage the study, what to monitor during its course, and how to ensure compliance with regulatory requirements. Finally, participants will learn how to properly prepare and manage clinical investigation/study documentation, including patient consent forms and progress reports.
The topics of the three modules are as follows:
- Planning and Essentials of a Clinical Investigation/Study
- Conduct and Management of a Clinical Investigation/Study
- Documentation of a Clinical Investigation/Study
Reference
Interested?
Are you interested in the course or training, but no dates are currently available, the listed date or format doesn’t suit you, or would you like to arrange training for a larger group? Don’t hesitate to contact us at info@biostatistika.cz – we’ll do our best to accommodate your needs.