FALSIFIED MEDICINES DIRECTIVE AND ACTIVE SUBSTANCES

Track:
Quality (including Falsified Medicines)

Day & Time:
March 5, 2:00PM - 3:30PM

Session Number:
0603

Room Number:
D203/D204

Type:
Session

Title:
FALSIFIED MEDICINES DIRECTIVE AND ACTIVE SUBSTANCES

Chair(s):
John Kerridge, PhD,RPh
Quality Leader, EU QA & EU GMP External Relations
Eli Lilly and Co Ltd, United Kingdom

Description:
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.

Presentation(s) & Speaker(s):
European Commission – update on the FMD and implementation of provisions for active substances
Stefan Fuehring
Administrator
European Commission, Belgium

Stakeholder Perspective on Active Substance Control
Isabelle Clamou
Director
EFPIA, Belgium

Regulator Perspective on Active Substance Control
Gerald W. Heddell
Director, Inspection Enforcement and Standards Division
MHRA, United Kingdom