Upcoming trainings
The next training date is not yet confirmed. Please inquire for more information.
Contact Aurevia Academy
academy@aurevia.comReceive updates about upcoming training sessions by subscribing to our newsletter.
Topics
- Medical Device Regulation 2017/745 (MDR), MDCG-Documents, ISO 14155:2020, Declaration of Helsinki, and other relevant regulations for Germany
- Ethics Commission (EC) and Competent Authority (CA)
- Conduct of a clinical investigation, documentation, monitoring, and informed consent
- Safety in clinical investigations, reporting obligations, and corrective actions
- Noncompliance, audits and inspections, and frequent problems
Trainers
Kirsten Sander, MSc Biology, is the Country Manager of Aurevia GmbH in Germany. She has been working in clinical research for more than 10 years, with experience in medical and scientific writing, monitoring, and project management. She has in-depth knowledge of regulatory requirements for clinical investigations (EU MDR, MDCG, ISO 14155, German MPDG), clinical evaluations, and post-market clinical follow-ups.
Target group
Investigators, members of clinical investigation teams/groups, or persons working in clinical research, safety reporting, regulatory affairs, and quality management. This training is for beginners and advanced learners in this field.Objectives
After this course, participants will:- Be able to act as an investigator or in a clinical investigation team/group
- Know the specific regulatory requirements for clinical evaluations with medical devices
- Understand the relevant tasks during a clinical investigation