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Dorint An der Messe Basel

Oct 17, 2013 8:45 AM - Oct 17, 2013 5:30 PM

Schönaustrasse 10, 4058 Basel, Switzerland

Combination Products Workshop – Regulatory Landscape for Drug/Device Combinations and Companion Diagnostics

OVERVIEW OF CHANGING THE REGULATORY FRAMEWORK FOR COMBINATION PRODUCTS, MDD AND IVD

Speaker(s)

Shayesteh  Fürst-Ladani, MBA, MS

Overview of Latest Development on the Proposed Revision of Medtech Legislation and Impact on Regulatory Framework for Combination Products

Shayesteh Fürst-Ladani, MBA, MS

SFL Regulatory Affairs & Scientific Communication, Switzerland

CEO

Waldo  Weijers, PharmD

Regulator View of European Legislation for Combination Products

Waldo Weijers, PharmD

Medicines Evaluation Board, Netherlands

Secretary / Coordinator Consultation Procedures

Theresa  Jeary, MSc

Notified Body View on Revision of European Medtech Law Impacting Combination Products

Theresa Jeary, MSc

Lloyds Register Quality Assurance (LRQA), United Kingdom

Head of Notified Body

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