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HARMONISATION: CHALLENGES IN PRODUCT INFORMATION / LABELLING
Session Chair(s)
Dinah Duarte, MSc
Signal Management Lead
European Medicines Agency, Netherlands
Th This year will be challenging in terms of drug product information. The implementation of the pharmaceutical package and the European Commission report on patient information will lead to improved product information in order to increase their value for the healthcare professionals and the general public. The key need for many patients is to have access to harmonised information of multi source products. This session therefore will explore amongst regulators and consumer organisations ways to improve patient information and their contribution to the rational use of medicines and patient safety.
Speaker(s)
The Changing Environment for Product Information Harmonisation – A regulators perspective
Sandra Petraglia, MD, PhD
AIFA - Agenzia Italiana Del Farmaco, Italy
Head of Pre Authorisation Department
Bridging Labelling Expectations in the New Regulatory Framework - the industry's challenge
Barbara Lachmann, MD
Barbara Lachmann Labeling Consulting, Germany
Sole Proprietor
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