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CLINICAL INVESTIGATIONS FOR MEDICAL DEVICES AND COMBINATION PRODUCTS

Track:
Regulation of Medical Devices and Combination Products

Day & Time:
March 27, 4:00PM - 5:30PM (Central European Standard Time)

Session Number:
1108

Room Number:
Room I

Type:
Session

Title:
CLINICAL INVESTIGATIONS FOR MEDICAL DEVICES AND COMBINATION PRODUCTS

Chair(s):
Ilona G. Reischl, PhD
Senior Assessor
AGES/BASG, Austria

Description:
Clinical investigations of medical devices and combination products will be the focus of this session. Regulatory and scientific requirements will be presented and discussed, with particular emphasis on specific issues at the intersection of the medicinal product and medical device frameworks.

Presentation(s) & Speaker(s):
Notified Body’s Requirements for Clinical Investigations for Devices and Combination Products
Tina Amini
Pharmaceutical Expert, Device/Drug Combination Products
BSI Group, United Kingdom

Authority’s Requirements for Clinical Investigations for Medical Devices and Combination Products
Ilona G. Reischl, PhD
Senior Assessor
AGES/BASG, Austria

Post Marketing Studies with medical devices in Europe
Vytis Jusevicius
Project Director
Aptiv Solutions, Switzerland