When: 24 September 2025
Where: TOPRA 3rd Floor, City Reach, 5 Greenwich View Place, London, E14 9NN
Time: 08:45-17:10 BST
This course is also available to take part in person.
Suitable for
This course is designed for those:
- 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.
Course information
This one day workshop from regulators and industry experts will provide insight into European SmPC, package leaflet (PL) and label preparation and implementation, from a strategic and practical point of view.
Benefits to delegates
- Meet and learn from experts in the field
- Learn by doing - participate in case studies and interactive sessions
- Build a network to support the rest of your career
- Overview of the European SmPC, PL and labelling legislation and guidelines including an overview of the EMA QRD templates, readability, Braille, excipients and translations and timings
- Practical advice on how to comply with European labelling legislation and guidelines, for products registered through the centralised, decentralised and mutual recognition or national procedures
- 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
- Outline of the contentious sections, and overcoming common pitfalls
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
Please see course programme here.
Presenters
- Natalie Clark, Global Regulatory Affairs Labelling Director, GSK
- Ronan Donelan, Policy and Stakeholder Lead, Health Products Regulatory Authority (HPRA)
- Gabriela Fok CSci, Senior Regulatory Affairs Manager, Ipsen
- Junias Adu – Gyamfi, Senior Regulator Affairs Project Lead, Ipsen
- Kay Loughrey, Team Lead (Director) of Global Product Labelling Operations, Jazz Pharmaceuticals
- Emily Meegan, Regulatory Affairs Officer, Ipsen
- Ronnie Mundair, Regional Labelling Head, Snr. Director, Pfizer
- Nageen Hashmi, Senior Executive Office, Medicines and Healthcare products Regulatory Agency (MHRA)
- Crystal Nkafu, Regulatory Affairs and Quality Officer, Ipsen
- Petrina Pearce, Senior Manager Regulatory Affairs New Products, ADVANZ PHARMA
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£620.00 + VAT* |
Standard Price
Non-member |
£720.00 + VAT* |
Include membership with your booking below to unlock members' discounts. By becoming a TOPRA member before September 30 2025, 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.
*VAT, where applicable, is charged at the rate of 20%.
| Discounted training course registration fees |
| Event Registration Type |
Price (GBP) |
Government or academic rates
TOPRA Member
|
£465.00 + VAT* |
Government or academic rates
Non-member
|
£540.00 + VAT* |
Charities, patient groups, full-time education rates
TOPRA Member |
£310.00 + VAT* |
Charities, patient groups, full-time education rates
Non-member
|
£360.00 + VAT* |
Places are also available for those in low-income countries as defined by the World Bank.
*VAT, where applicable, is charged at the rate of 20%.
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions.