When: 11 June 2021
Where: Online*
Time: Times to be confirmed
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 the 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.