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Topics
- What is a publication, reasons and goals, regulatory requirements, different forms of publication, and target groups
- Research before publishing, journal selection, requirements for authors, literature research, data selection, quality control, dealing with negative data and inconsistent results, merging data from multiple studies, criteria and checklists, CONSORT, further standards, criteria and checklists
- Minimum standards for scientific publications, the writing process, correct formulation, and target group orientation
- Publication as a marketing tool, regulations to be observed, advertising ban and special cases, problematic statements, practical problems with scientific publications, and cost/benefits considerations
- Workshop: Consideration of the publication already in the study planning, decision on the publication of the results, and application of the CONSORT criteria
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 requirements for publications about medical devices
- Be aware of the different options which exist in this context and how to select the right scientific journal
- Know which writing techniques are expected
- Be able to handle the peer-review process until reaching acceptance of the publication
- Understand how to prepare a scientific publication taking into account the requirements for the specific medical device