Mastering EU Requirements for Product Labelling & Package Leaflets

This interactive three-day course will clarify the European regulatory requirements for developing labelling and package leaflets and clearly interpret the Directive 92/27/EEC. The course will also provide practical guidelines for designing and writing Patient Information Leaflets to meet regulatory requirements and satisfy readability and compliance needs. In the face of increasing regulatory and consumer demand, the need for accurate and complete product information has never been stronger. This course will provide you with key practical information on devising successful labelling strategies to guarantee complete compliance.

• Design a comprehensive information for your product
• Know exactly what information must be included in the Patient Information Leaflets (PILs) in Europe and the SmPC to ensure a successful application
• Access a clear interpretation of the legal constraints affecting the contents of labels and package leaflets
• Be prepared to be held liable for misinformation
• Develop tools for testing the readability of your PILs
• List adverse events without affecting patient compliance
• Develop a labelling strategy at an early stage of your product registration process
• Implement practical steps to successfully work with your marketing team
• Know what should be on a leaflet/carton/label
• Review your legal liability
• Test your PILs for readability criteria
• Utilise data for maximum clarity
• Understand the requirements for provision of patient information in Europe
• Clarify the practical consequences of the Directive 92/27/EEC, and its
• Supporting guidelines on labelling and package leaflets

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