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Topics
- Medical Device Regulation 2017/745 (MDR), MDCG documents, ISO 14155:2020, Declaration of Helsinki and GDPR
- Submission to Ethic Committees and Competent Authorities
- Conducting the clinical investigation, documentation, risk-based monitoring, and informed consent
- Safety in clinical investigations, reporting obligations, and corrective actions
- Noncompliance, audits and inspections, and frequent problems
- Workshop: development of a concept for a clinical investigation
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
People working in clinical research, safety reporting, regulatory affairs, and quality management.Objectives
After the course, participants will:- Be familiar with the specific regulatory requirements for clinical investigations with medical devices
- Be able to develop a clinical investigation plan and synopsis
- Understand which ethical, scientific and quality aspects need to be considered, including an understanding of what problems may arise and how they can be solved.
- Be equipped to plan, conduct and evaluate a clinical investigation with a medical device and understand the relevant regulatory requirements.