An Overview of Regulatory Product Information

An Overview of Regulatory Product Information
Strengthen your expertise in regulatory product information and develop the skills needed to manage SmPCs, package leaflets and labelling requirements across the EU and UK. Gain practical insights into regulatory compliance, cross-functional collaboration and future developments in digital product information, helping you increase your impact and effectiveness in regulatory affairs.






When: 14 September 2027
Where: Online
Time: 08:45-17:10 GMT
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 and UK regulatory framework for SmPCs, package leaflets and labelling.
  • Apply regulatory requirements and best practices to develop and maintain compliant product information.
  • Plan and coordinate cross-functional activities that support effective product information management.
  • Manage pack changes and product information updates while meeting regulatory and business requirements.
  • Identify common challenges and risks in regulatory product information and apply strategies to avoid them.
  • Evaluate emerging trends and digital innovations shaping the future of product information and labelling.


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.

Presenters

The expert presenters for this course will be announced soon.

Pricing

TOPRA member: £650 + VAT
Non-member: £910 + VAT

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Members working for regulatory or government agencies, academic institutions, charities, patient groups, emerging markets and MSEs can access further discounted rates. Please email meetings@topra.org before 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.

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Terms and conditions

By booking a place on this course you are agreeing to the Training Terms and Conditions.
When
14/09/2027
Where
Online
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