***We’ve gone Virtual – Please note new dates!***
Due to the pandemic the conference will now take place as a virtual event online and will be broadcast on 23-24 November 2020
It is with great pleasure that we invite you to attend The Virtual (European) Conference on Clinical Studies with Medical Devices and IVDs (CSMD2020) which will take place 23-24 November 2020 online.
The Conference is designed to address the most challenging and perplexing aspects of planning and conducting medical device and IVD clinical studies in accordance with the requirements of the European Medical Device Regulation (MDR, 2017/745) and the In Vitro Diagnostic Regulation (IVDR, 2017/746).
Highly experienced and accomplished experts will share their knowledge and practical advice regarding the design, conduct and regulation of medical device and IVD clinical studies, including best practices and mistakes to avoid. Every effort will be made to provide practical, usable information to help attendees understand what must be done, but also avoid errors that will increase costs and extend timescales.
The Conference will be of interest to all who are involved in planning, designing, conducting, sponsoring, evaluating or assisting in medical device or IVD clinical study-related activities.
Topics to be covered during the conference:
- Competent authority views on managing MDR clinical study applications
- Competent authority update on preparation for IVDR study applications
- Notified Body assessment of clinical study strategies
- Industry view on implementation of MDR and IVDR clinical study requirements
- International standard for conducting medical device studies: ISO 14155:2020
- International standard for conducting IVD clinical performance studies: ISO 20916:2019
- Clinical Investigation Plans that meet regulatory and operational requirements
- Key statistical elements of a successful clinical study
- Critical considerations in site selection and subject enrollment
- New medical device clinical safety reporting requirements
- MDR requirements on sponsor GCP audits and how to conduct them
- Aligning clinical investigations and risk management for MDR compliance
- Effective compliance with clinical study-related European privacy requirements
- Remote conduct of clinical studies: digital tools and key concepts
- PMCF investigations, regulatory requirements and practical considerations
We very much look forward to seeing you online.
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| Marie E. Donawa, MD | Danielle Giroud |
| Conference Co-Chairs | |