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CHALLENGES AND OPPORTUNITIES IN THE IMPLEMENTATION OF THE FALSIFIED MEDICINES DIRECTIVE

Track:
Regulatory Science

Day & Time:
March 27, 11:00AM - 12:30PM (Central European Standard Time)

Session Number:
0106

Room Number:
Room E1

Type:
Session

Title:
CHALLENGES AND OPPORTUNITIES IN THE IMPLEMENTATION OF THE FALSIFIED MEDICINES DIRECTIVE

Chair(s):
Maren von Fritschen, PharmD
Managing Partner
PharmaLex GmbH, Germany

Description:
A falsified medicine is any medicinal product with a false/fake representation of its identity, source or history. The Falsified Medicines Directive, FMD (Dir 2011/62/EU) substantially changes the European framework for the supply of medicines. The issues relating to the implementation of the FMD will be considered from the perspective of EU regulators, inspectorates and industry. This will include a review of the current status, practical aspects and options and effectiveness of required changes to further protecting patients from the scourge of fake medicines. A panel discussion will give room for consideration of the perspectives of all involved parties.

Presentation(s) & Speaker(s):
Challenges and Opportunities in the Implementation of the Falsified Medicine Directive from the Perspective of EU Regulators and Inspectorates
Gerald W. Heddell
Director, Inspection Enforcement and Standards Division
MHRA, United Kingdom

Optimising Labelling for a Digital Age
Petra Wiesinger
Clinical assessor and qualified person for regulatory affairs, QRD Member
AGES Pharmmed, Austria

Challenges and Opportunities in the Implementation of the Falsified Medicine Directive from Industry’s Perspective
Alexander Natz, JD
Secretary General
European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Belgium