CRED SmPC, Patient Information Leaflet & Labelling

CRED SmPC, Patient Information Leaflet & Labelling
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. 




ONLINE REGISTRATION IS NOW CLOSED FOR THIS MEETING
IF YOU ARE INTERESTED IN REGISTERING, PLEASE CONTACT: SARAH@TOPRA.ORG


Who should attend

  • 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. 

Course content 

  • 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 
  • Case study workshop. 

CPD

This course offers 6 CPD hours for successful completion, to learn about why CPD is important visit the Lifelong Learning page.


    Download the full programme



    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.


    Course price (to register, please log in or create an account)


    Member:  £550+VAT          Non-member:  £675+VAT 


    Those working for regulatory agencies or government agencies or academic institutions:  

    Member:  £412.50+VAT           Non Member:  £506.25+VAT 


    Those working for charities, patient groups or in full time education: 

    Member:  £275+VAT           Non Member:  £337.50+VAT 



    If you book on the CRED Variations and CRED SmPC course you are entitled to a 15% discount, please contact the professional development team for the discount code.


    For a discount please contact the professional development team for the code (please note the number of discounted places may be limited.)


    - All fees are shown in Pounds Sterling and do not include VAT 
    - Fee excludes accommodation and travel. The delegate ticket includes refreshments at coffee breaks and buffet lunches (if applicable).
    When
    15/06/2017
    Where
    SmPC, Patient Information Leaflet & Labelling Doubletree By Hilton London Victoria 2 Bridge Place, Victoria London SW1V 1QA UNITED KINGDOM
    Your company name
    Your VAT country
    Your VAT number
    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

    Register now