返回 Agenda
Import Testing: Current Requirements and Opportunities to Simplify Access of Medicines for Patients
Session Chair(s)
Joerg Garbe, PHD, MSC
IFPMA In-Country Testing Taskforce Lead; Global Quality Manager & Policy Lead
F. Hoffmann-La Roche Ltd, Switzerland
This session will demonstrate the legal requirements and clarify misconceptions on import testing. Product knowledge as well as good manufacturing and distribution practices provides assurance of safe and effective medicines delivered to patients. Delays and impact to supplies of medicines to patients due to duplicate/redundant testing will be highlighted.
Speaker(s)
Opportunities for Improved Access to Safe and Efficient Medicines
Stephan Roenninger, DRSC
Amgen (Europe) GmbH, Switzerland
Director, Quality Compliance External Affairs
Market Surveillance Testing of Medicinal Products by the European OMCL Network
Michael Wierer, DRSC
European Directorate for the Quality of Medicines and HealthCare, France
Head, Biological Standardisation, OMCL Network, Blood Transfusion and Transplant