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Writing Effective Product Information

Price

£810*

Location

London, UK

Date

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?

When:
11 October 2018

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

*Cost?

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.

Email info@topra.org

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