Donawa Lifescience will again be participating in the 2020 RAPS Euro Convergence Conference, now being held in Brussels from 26-28 October 2020.
Donawa Lifescience will be involved in two conference sessions, the first conference session specifically dedicated to In Vitro Diagnostic Devices, in which Donawa’s President, Maria E. Donawa, M.D., will chair the session, titled ‘Conduct of an Actual IVD Study Compared with Provisions of ISO 20916:2019 – The New Standard for IVD Clinical Performance Studies’, taking place at 13:30 on the second day. Daniela Karrer, Donawa’s VP Operations and Clinical Affairs, together with Matteo Mosso, Donawa’s Senior Clinical Project Manager, will present on two topics:
The first will describe the study planning phase including quality system set up and preparation of study documents; and the second will focus 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 will be provided. This approach will help IVD manufacturers to better understand how to transfer theory to compliant and effective study practice.
Daniela Karrer will also speak on the third day, at 09:45, on the subject of ‘Creating and Implementing Effective Post-market Clinical Follow-up Under the EU Medical Devices Regulation’, a session that she will share with Adrian Keene, Director EMEA, NAMSA. Daniela will provide practical insight into various options for meeting the new PMCF requirements in the MDR during her part of the session.