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FALSIFIED MEDICINES DIRECTIVE AND ACTIVE SUBSTANCES
Session Chair(s)
John Kerridge, PhD, RPh
Director Of Quality, External Manufacturing Europe, Africa, Asia
LILLY FRANCE, France
A vitally important topic, this session will discuss the current status of the implementation of the EU Falsified Medicines Directive as it relates to active drug substances including the provisions for importation. It is vital that all stakeholders work together to ensure a smooth implementation of the provisions to allow a continued supply of quality and safe medicines in the Union. The active participation of 3rd countries is a key element of making these provisions a success and the status of this and future plans will be discussed.
Speaker(s)
European Commission – update on the FMD and implementation of provisions for active substances
Stefan Fuehring
European Commission, Belgium
Administrator
Stakeholder Perspective on Active Substance Control
Isabelle Clamou
European Commission, Belgium
Policy Officer, DG SANTE Unit D2
Regulator Perspective on Active Substance Control
Gerald W. Heddell
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Director, Inspection Enforcement & Standards Division
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