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An Overview of Regulatory Product Information




London, UK


11 Mar 2020

Reference No: T2002394-TOP

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Key points about this Training Event

  • Meet and learn from experts in the field
  • 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
  • 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
Event Description


Course Outline:

This one day workshop from regulators and industry experts will provide an insight on European SmPC, package leaflet (PL) and label preparation and implementation, from a strategic and practical point of view.

When & Where?

11 March 2020

TOPRA  6th Floor
3 Harbour Exchange
South Quay
London, E14 9GE


Course fee for members: £660 Plus 20% VAT
Course fee for non-members: £810 Plus 20% VAT

Applicant Requirements
  • 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
Reference No: T2002394-TOP
TOPRA is the professional membership organisation for individuals working in healthcare regulatory affairs.
We work with our members internationally to enable and promote excellence across the healthcare regulatory profession.


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