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Post-Market Surveillance and Vigilance – Globalisation and Data Pooling
Session Chair(s)
Eric Klasen
Vice President, Regulatory Affairs & Quality
Medtronic International Trading Sarl, Switzerland
Post-Market Surveillance and Vigilance – Globalisation and Data Pooling
Speaker(s)
What is in the Law, What is Reportable?
Bassil Akra, PhD
QUNIQUE GmbH, Germany
CEO
Practical Industry Interpretation of Reportability and How to Prepare for Trend Reporting
Philippe Soly, MSN
Philips Healthcare, France
Director of Global Regulations, European Authorised Representative
Agency Cooperation and Cross-Agency Reporting – Legal View
Reinhard Berger, DrSc, MSc
Consulting-Advising, Austria
Regulatory Affairs Medical Devices
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