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Audio conference highlights

Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.

In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.

This audio conference covers:

• The complexity and importance of regulatory compliance
• Advantages of using e-labeling
• Challenges of using e-labeling
• e-labeling compliance issues and system requirements
• e-labeling and competitive advantage

About the speaker:

Salma Michor, PhD, is founder and CEO of Michor Consulting EU, serving such clients as Johnson & Johnson, Novartis, Valeant Pharma and Colgate Palmolive. Previously, Michor worked in regulatory and quality assurance with Chiesi-Torrex and Wyeth Whitehall export, and as director of supporting operations at Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. Michor served on the RAPS Board of Editors, 2005–10, and is a member of the RAPS European Advisory Committee. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King’s College, University of London in food technology; and an MBA from Open University, and has earned the EU RAC.

Who should attend?

• Regulatory Affairs
• Quality Assurance
• Project Coordinators
• Packaging Technologists
• Artwork and Labeling
• Safety Officers and Managers

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.