戻る Agenda
ISO 14155: 2020 Revision of Medical Devices Good Clinical Practice
Session Chair(s)
Milos Stojkovic, MPHARM
Safety Process Director
F. Hoffmann-La Roche Ltd, Switzerland
In Medical Devices the EU MDR is driving the headlines these days, takeaway being that much more emphasis is placed on clinical data. Trying to understand how to obtain clinical data, in this session we ask – are you familiar with Good Clinical Practice (GCP) requirements for Clinical Investigations of Medical Devices? If not – this session will bring you up to speed; if you already are – join us to discuss the changes 2020 revision of ISO 14155 will bring into practice.
Speaker(s)
Understanding GCP for Medical Devices with respect to newly revised ISO 14155:2020
Milos Stojkovic, MPHARM
F. Hoffmann-La Roche Ltd, Switzerland
Safety Process Director
Role of GCP Certification in Clinical Investigations conduct
Susanne Gerbl-Rieger, DRSC
Dr. Susanne Gerbl-Rieger, Germany
Department Manager of Clinical Audit, Clinical Centre of Excellence (cCE)
Impact of Device GCP revision on Clinical Investigations in the Digital Era
Fiona Maini, MS
Medidata a Dassault Systèmes Company, United Kingdom
Principal Global Compliance and Strategy Principal