Donawa Lifescience again participated in the 2020 RAPS Euroconvergence Conference, held as a ‘virtual event’ from 26 to 28 October 2020.

RAPS is the largest global organization serving regulatory professionals and the regulatory profession worldwide, and the RAPS European Regulatory Conference is designed by European regulatory affairs professionals for European regulatory professionals, and a place where the regulatory community can gather to discuss the most pressing regulatory topics of the moment, share experiences and network with other stakeholders.

A wide range of current issues facing medical device, IVD and medicine regulatory professionals was covered at the 2020 event, as well as general subjects that impact all professionals in the healthcare space.

Donawa Lifescience was involved in two sessions, including the first conference session specifically dedicated to In Vitro Diagnostic Devices, in which Donawa’s President, Maria E. Donawa, M.D., chaired the session titled ‘Conduct of an Actual IVD Study Compared with Provisions of ISO 20916:2019 – The New Standard for IVD Clinical Performance Studies’, which took place on the second day. Daniela Karrer, Donawa’s VP Operations and Clinical Affairs, together with Matteo Mosso, Donawa’s Senior Clinical Project Manager, also presented on two topics:

The first described the study planning phase, including quality system set up and preparation of study documents; and the second focused on compliance with the ISO 20916 standard during the data collection phase of the study, providing details on the control mechanisms adopted to ensure data quality.

During both parts of the session, useful tips on study conduct to avoid problems and delays were provided. This approach will help IVD manufacturers to better understand how to transfer theory to compliant and effective study practice.

Daniela Karrer also spoke on the third day, on the subject of ‘Creating and Implementing Effective Post-market Clinical Follow-up Under the EU Medical Devices Regulation’, a session that she shared with Adrian Keene, Director EMEA, NAMSA. Daniela provided practical insight into various options for meeting the new PMCF requirements in the MDR during her part of the session.