CRED An Overview of Regulatory Product Information

CRED An Overview of Regulatory Product Information
This one-day workshop with expert speakers from health authorities and industry will give you an understanding of the strategic development of the regulatory product information in Europe and UK. From company core data sheet to Summary of Product Characteristics (SmPC), Labelling and the Package Leaflet (PL). This is a hands-on workshop covering not just the theoretical approach to creating product information in Europe, but also includes practical exercises for the preparation and implementation of Labelling. You will also hear an overview on what in the pipeline on future digital advancements for labeling.


When: 24 September 2025
Where: Online
Time: 08:45-17:15 BST 

Also available as a face-to-face course, please click here for the face-to-face registration option. 

Course overview

This course will take you through the most important aspects of the development of regulatory product information in Europe as well as some future aspirations. The journey starts with the company core data sheet and continues through to the strategic development of the SmPC, Labelling and package leaflet with an overview of the digital landscape. Case studies will enable you to put theory to practice and further deepen your understanding of the topic. A panel discussion provides the opportunity to ask questions and confirm your understanding.
Representatives from health authorities as well as from the pharmaceutical industry provide their perspectives and an opportunity to discuss recent developments in the legal framework, guidelines and practical issues encountered in the negotiation and placing on the market of product information in Europe as well as digital advancements..

Benefits to delegates

  • Meet and learn from experts in the field
  • Practical learning - participate in case studies and interactive sessions
  • Build a network to support the rest of your career
  • Overview of the relevant legislation and guidelines including the QRD template, readability requirements, Braille, excipients and other guidelines, requirements for translations and critical timelines during health authority review
  • Practical advice on how to comply with labelling requirements and guidelines for products registered through the centralised, decentralised and mutual recognition or national procedures in Europe
  • Cross functional planning
  • Overview of future developments in labelling regulations and guidelines
  • Guidance on practical aspects of pack changes including how to effectively manage the implementation of pack changes resulting from changes to the SmPC while meeting legislative and ethical requirements
  • Frequent labelling challenges and how to avoid common mistakes
  • What you can expect from the digital perspective in the future (e.g. ePI)
CPD: This course provides 8 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme

Download a copy of the course previous year programme here.

Presenters

Past Presenters include:
  • Julia Coombes, MHRA
  • Gabriela Fok, Ipsen 
  • Robert Hetherington, ICON plc
  • Khristy Horsley, ICON plc
  • Lucy Paterson, ICON plc
  • Petrina Pearce, Advanz Pharma
  • Thomas Liebers, PRAHealthSciences

Suitable for

This course is aimed at regulatory affairs professionals with 3-5 years of experience, who have a basic understanding of the regulatory framework in Europe and want to learn more about product information and labelling. Regulatory professionals with more than 5 years of labelling expertise in other regions will expand their knowledge to learn about requirements in Europe. and gain an awareness of digital landscape specific to labelling. 

Pricing  

Course *fees:
Type Member Non-member 
Standard    £620+VAT  £720+VAT
Include membership with your booking below to unlock members' discounts. By becoming a TOPRA member before September 30, 2023, you'll receive an additional 3 months of membership for just £20 (subject to terms and conditions). Join now to access exclusive member content and enjoy discounts on courses, including this year and next year's Annual Symposium. Please be aware that membership fees are exempt from VAT.

Discounted places
A limited number of discounted places are available at the rates below.
Please email us at meetings@topra.org for a discount code before making your booking.

  
Those working for regulatory agencies, government agencies or academic institutions 
  £465+VAT
 £540+VAT 
Those working for charities, patient groups or in full-time education
  £310+VAT  £360+VAT

*VAT, if applicable, is charged at the rate of 20%

Terms and conditions

Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions. 
When
24/09/2025
Where
Online
Online registration not available.
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Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

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