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)

Sumaiya Patel

Sumaiya Patel is a director of a regulatory consultancy with over 11 years’ experience in both pre and post-approvals for generic, CRO and big pharma organisations. Sumaiya has experience in regulatory implementation and training, focusing on CMC, clinical development, strategy and manufacturing. She has extensive experience in writing Module 3 of CTD, Module 2 of the CTD and also Quality Expert statements to support dossiers and Type II Quality variations. She has a track record of providing regulatory inputs related to CMC aspects during the development product lifecycle.

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.