An Overview of Regulatory Product Information

An Overview of Regulatory Product Information
Master the strategic development and practical implementation of regulatory product information in Europe and the UK through this hands-on course, featuring expert insights on SmPCs, labelling, and upcoming digital innovations.





When: 14 September 2027
Where: Online
Time: 08:45-17:10 BST
CPD: 8 CPD hours upon successful completion


Who should attend

This course is ideal for:

  • Less experienced regulatory professionals who require comprehensive information on product information
  • Experienced professionals who are newcomers in the product information area
  • Anyone who wishes to update or refresh their knowledge in product information

What you'll learn

By completing this course, you will be able to:

  • Understand the European regulatory framework for the SmPC, Package Leaflet (PL), and labelling, including EMA QRD templates, readability requirements, Braille, excipients, translation processes, and timelines
  • Apply practical strategies to comply with European labelling legislation and guidelines for products registered through the centralised, decentralised and mutual recognition or national procedures
  • Plan cross-functional activities to support effective regulatory product information development and maintenance
  • Anticipate and assess future developments in labelling regulations and guidelines
  • Manage the practical aspects of pack changes, including the effective implementation of changes arising from SmPC updates while meeting legislative and ethical requirements
  • Identify contentious sections of regulatory product information and avoid common pitfalls

Course overview 

This course offers essential insights into the strategic development and practical preparation of EU and UK product information, including Summary of Product Characteristics (SmPC), package leaflets (PL) and labelling. Expert speakers from health authorities and industry will lead this course which combines theory with practical exercises. There will also be an overview of upcoming digital advancements in labelling.

 
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When
14/09/2027
Where
Online
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