Maria Donawa to chair Vienna Conference on Clinical Studies with Medical Devices and IVDs

The “European Conference on Clinical Studies with Medical Devices and IVDs” (CSMD2020) will take place on 16-17 November 2020 in Vienna, Austria.

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).

The Conference will be chaired by Maria E. Donawa, MD, President of Donawa Lifescience, headquartered in Rome, Italy, with over 30 years’ regulatory experience, including six years with the US FDA, in the area of medical device regulation. Dr Donawa is an active member of the ISO study group responsible for the development and revision of ISO 14155, the international standard for medical device clinical investigations. She is also a stakeholder observer to the Clinical Investigation and Evaluation (CIE) Working Group. The CIE assists the Medical Device Coordination Group (MDCG) on issues relating to clinical investigation and evaluation of medical devices in accordance with the MDR.

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 include:

• Regulatory authority view of the new clinical study regulations
• Notified Body procedures related to the evaluation of clinical investigations
• Newly developed European guidance documents important for European clinical study conduct
• International standards for conducting medical device and IVD studies: revised ISO 14155 and ISO 20916:2019
• Quality system concepts in clinical study planning, management, and regulatory compliance
• 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
• PMCF investigations, regulatory requirements and practical considerations
• New medical device clinical safety reporting requirements
• Investigator-initiated studies, new requirements, new considerations
• Effective compliance with clinical study-related European privacy requirements
• Manufacturer best practices for working with CROs

Further details of the program will be available shortly.