FALSIFIED MEDICINES DIRECTIVE AND SERIALISATION

Track:
Quality (including Falsified Medicines)

Day & Time:
March 5, 4:00PM - 5:30PM

Session Number:
0604

Room Number:
D203/D204

Type:
Session

Title:
FALSIFIED MEDICINES DIRECTIVE AND SERIALISATION

Chair(s):
Domenico Di Giorgio, PhD
Chair, CoE/EDQM Comm. Counterfeit Medicine; Director Unit, Counterfeits
Italian Medicines Agency (AIFA), Italy

Description:
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.

Presentation(s) & Speaker(s):
EU Directive 2011/62 - Features and points of view
Domenico Di Giorgio, PhD
Chair, CoE/EDQM Comm. Counterfeit Medicine; Director Unit, Counterfeits
Italian Medicines Agency (AIFA), Italy

The Implementation of the FMD vs. the Improvement of Supply Chain Management
Maarten Van Baelen, MPharm
Medical Affairs Manager
EGA - European Generic Medicines Association, Belgium

eTACT- The EDQM Anti-Counterfeiting Traceability Service for Medicines
Francois Lery, PharmD
Head of Section for Pharmaceutical Care
European Directorate for the Quality of Medicines , France

The European Stakeholder Model
John Chave, LLM
Secretay General
PGEU, Belgium