When: 11 June 2021
Where: TOPRA Office, 3 Harbour Exchange, London, E14 9GE, United Kingdom *
Time: Times to be confirmed
* Also available as an online course. Please click here for more information
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 last year's programme here.
Presenters
Past presenters for this course have come from Celgene, HPRA, Shire Pharmaceutical, MHRA, BioMarin and Pfizer Consumer Healthcare.
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
Standard
- Member: £550+VAT*
- Non-member: £675+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:
- Members: £412.50+VAT*
- Non-members: £506.25+VAT*
-
Those working for charities, patient groups or in full-time education:
- Members: £275+VAT*
- Non-members: £337.50+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.