CRED Writing Effective Product Information

CRED Writing Effective Product Information
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: 11 October 2018 
Where: TOPRA, 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE
Time: 09.00 - 17.25 (BST) 


What is it?
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.

Who is it for?
This course is for those who:
  • The less experienced regulatory professional who requires comprehensive information on a subject
  • The experienced professional who is a newcomer to a particular regulatory aspect
  • Anyone who wishes to update their knowledge in a particular subject area.


What will I learn?
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

Download the course programme

CPD: 8


How do I apply? 
Simply loginor create an account and register below. 

Course fees:
Type Member  Non-member 
Standard    £660+VAT £810+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 
  £412.50+VAT
  £506.25+VAT
Those working for charities, patient groups or are in full-time education
  £275+VAT
  £337.50+VAT

 

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.
When
11/10/2018
Where
TOPRA Ltd 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
Online registration not available.
My registration status: Not registered
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NOTE
Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

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