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Writing Effective Product Information




London, UK


11 Oct 2018

Reference No: T1803290-TOP

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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

This course will provide an: 

  • 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

When & Where?

11 October 2018

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


TOPRA Member: £660 plus 20% VAT
TOPRA Non-member: £810 plus 20% VAT


Applicant Requirements
  • For those who wish to build credibility by being able to demonstrate the practical understanding and the complexity of European regulatory variations
Reference No: T1803290-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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