This course is also available to attend in-person.
When: 2 September 2026
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.
Course presenters
Course presenters will be announced in the near future.
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£650.00 + VAT* |
Standard Price
Non-member |
£910.00 + VAT* |
Those working for regulatory or government agencies, academic institutions, charities, patient groups, emerging markets, and MSEs (Micro and Small Enterprises) can also access discounted rates by becoming a TOPRA member. For more information about the discounts available, please email meetings@topra.org before making your booking.
Important Notice On VAT
In compliance with regulations, a *20% VAT will be charged to attendees only where applicable. If you have a VAT number or if the company or organisation you are affiliated with has a VAT number or equivalent please ensure it is visible on your profile. If your VAT number is not visible on your profile, please email finance@topra.org to have it updated. If you do not have a VAT number, there is no action required — VAT will be applied accordingly during the registration process. Please observe that the VAT number needs to be valid.
Click here to check and validate your VAT number.
For EU countries; if you are unsure of the VAT number, click here to check and validate your VAT number.
Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.