EU & US Requirements for Pharmaceutical Labelling & Package Leaflets

• Create SmPCs, PILs, and labels to meet EU and US requirements
• Review examples of PILs to avoid common mistakes and deficiencies
• Learn how to navigate the EU regulatory maze of EU PI
• Clarify the regulations and practical implementation EU legislation
• Implement the readability guideline of the PILs and QRD reference PI
• Understand what readability really means without conducting user testing
• Compare user testing with FDA testing methods such as ‘label comprehension studies’ of non-prescription drugs or Failure Mode Effects Analysis
• Understand evaluation of container labels and carton labelling, as well as ‘human factors engineering’
• Recognise the differences between the EU SmPC (e.g. being conciseness and executive) and the US PI (e.g highlight opening section, detail)

Dr. Salma Michor, MBA, CMgr, RAC

Previously, Salma has worked for Chiesi-Torrex, Wyeth Whitehall and for Croma Pharma, where she was director of supporting operations, supervising regulatory affairs and compliance, change control and lifecycle management, pharmaceutical editing and packaging and the medical department. Michor Consulting has served among others such clients as Johnson & Johnson, Novartis, Valeant Pharma, Baxter AG, Almirall, UCB and Colgate Palmolive.

This course has been specifically designed to address the training
needs of Managers and Executives in area such as:

• Regulatory Affairs
• Product Labeling
• Legal Counsel
• Drug Safety
• Medical Affairs
• Marketing
• Medical Information

The course will be beneficial to people new in their role, and more
experienced professionals who need clarification on the new
requirements.