When: 27 September2023
Where: Online
Time: 08:45-17:10 BST
Course overview
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
Download a copy of programme here.
Presenters
Presenters include:
- Desta Black, GlaxoSmithKline
- Doreen Fagan, HPRA
- Julia Coombes, MHRA
- Gabriela Fok, Ipsen
- Matt Hancock, Pfizer
- Robert Hetherington, ICON plc
- Khristy Horsley, ICON plc
- Lucy Paterson, ICON plc
- Petrina Pearce, Advanz Pharma
- Thomas Liebers, PRAHealthSciences
- Kay Loughrey, Jazz Pharmaceuticals
Suitable 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/refresh their knowledge in product information.
Pricing
Course *fees:
| Type |
Member |
Non-member |
| Standard |
£550+VAT |
£675+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
|
£412.50+VAT
|
£506.25+VAT |
Those working for charities, patient groups or in full-time education
|
£275+VAT |
£337.50+VAT |
|
*VAT, if 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