Experts share advice on managing source data, local language labeling & country specific requirements
Global life sciences and medical device labeling is a complex subject and an integral part of the supply chain. The landscape is varied in terms of the systems and processes employed in designing, populating and printing labels (including booklets, inserts and IFUs). To control labeling on a global scale a number of key functions need to be managed including:
• Complexities around local language labeling
• Managing source data for labels, booklets, inserts and IFUs
• Customizing labels for country specific requirements
Medical materials are shipped across many countries and many continents. For the sake of patient safety, the ability to control these materials’ labels at a global level is paramount. Labels must therefore be safely and accurately customized not only so that they are in the appropriate local languages, but also ensure country specific nuances of including country specific designs and regulatory requirements are understood sufficiently to communicate coherently with users.
In this information-packed session, we explore what the industry can do to improve data security, adhere to regulations and mitigate the risks involved in local language labeling and country specific design.
Presented by
Aristotle Pantelis,
US Business Development
Aristotle Pantelis joined PRISYM ID in 2013 having previously worked for JH Bertrand for 10 years. He joins PRISYM ID as part of the life sciences and medical device team to deliver turn-key labeling solutions to empower organisations to implement seamless label lifecycle management ensuring their compliance and safeguarding their reputation.
Chris Doyle,
Marketing Manager for Healthcare
Chris Doyle joined GS1 UK in 2012 as the Industry Marketing Manager for Healthcare. For more than 40 years, GS1 has been working with its members to enable the efficient movement of goods and sharing of information. It drives supply chain efficiency alongside 111 other not-for-profit GS1 member organizations in 150 countries worldwide.
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Key Learning Objectives
- Gain an understanding of global labeling in practical terms.
- Understand how labeling systems can remove the perceived complexities of local language labeling.
- Realize how to manage source data for labels, booklets, inserts and IFUs.
- Learn how to customize labels for country specific requirements.
Audience
- Head of Regulations
- Head of Quality
- The Qualified
- Head of Compliance
- Head of Logistics
- Validation professionals
- IS/IT Managers
