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FALSIFIED MEDICINES DIRECTIVE AND SERIALISATION
Session Chair(s)
Domenico Di Giorgio, PhD
Director of Product Quality and Counterfeiting
Italian Medicines Agency (AIFA), Italy
The EU Directive 2011/62 will change the European pharmaceutical distribution framework, by defining new obligations and procedures aimed at strengthening the barriers against falsified medicines. One of the key features of the directive is the traceability scheme to be developed at the European level, based on the concept of serialisation of the packages of medicines. The session goal is the discussion between experts from private stakeholders and administration on the current situation and experiences in the field of traceability and serialisation, with an eye on future technical and regulatory development.
Speaker(s)
EU Directive 2011/62 - Features and points of view
Domenico Di Giorgio, PhD
Italian Medicines Agency (AIFA), Italy
Director of Product Quality and Counterfeiting
The Implementation of the FMD vs. the Improvement of Supply Chain Management
Maarten Van Baelen, MBA, MPharm
Medicines for Europe, Belgium
Market Access Director
eTACT- The EDQM Anti-Counterfeiting Traceability Service for Medicines
Francois Lery, PharmD, PhD
WHO, France
Coordinator for Technologies, Standards and Norms
The European Stakeholder Model
John Chave, LLM
PGEU, Belgium
Secretay General
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