Digitalisation of Clinical Research - Opportunities and Risks

26.11.2019

Digitalisation is becoming increasingly relevant in clinical research. What are the consequences for patients, manufacturers and clinical contract research institutes, data protection specialists and other parties involved in the planning and conducting of clinical trials?

MEDIACC participates on Friday (29.11.19) in the symposium "Digitalisation of Clinical Research - Curse or Blessing" of the Federal Association of Contract Research Organisations (BVMA). The legal requirements of the General Data Protection Regulation (GDPR) and the challenges of Medical Device Regulation (MDR) will be discussed. Present are university research institutions, large pharmaceutical companies, the BVMA executive board, representatives of the BfArM and lawyers.

We expect intensive discussions on the innovations which the Medical Devices Implementation Act (MPDG) will bring with it, which will be debated in the Federal Council on 20 December 19. The implementation of new, very influential laws such as the General Data Protection Regulation (GDPR), the Medical Device Regulation (MDR) and the Medical Devices Implementation Act (MPDG) in the context of the changes caused by digitalisation requires a high degree of cooperation between many specialists in their respective fields. This is the only way to ensure the safety of our patients, the positioning of Germany in Europe and worldwide, and to guarantee manufacturers of innovative products for the healthcare market a sustainable expansion in increasingly demanding markets.

We are looking forward to the exchange with colleagues and would like to inform you about the next steps on the way to modern, safe, patient-oriented clinical research. We are also happy to meet for project-related discussions.