Managing Lifecycle and Variations Effectively

Managing Lifecycle and Variations Effectively
Regulatory professionals in industry and agency spend a significant amount of time  on variations, so getting them right is critical.

When
: 12-13 June 2019  
Where: TOPRA, 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE
Time: 09.00 - 17.00



Course overview

This practical CRED workshop will explain the principles of the EU Variations Regulation. This workshop will also cover intricacies of procedures for grouping and worksharing, and use examples to illustrate the guidelines on categorisation. Other critical actions for effective lifecycle management will be discussed. 

Benefits to delegates

  • Meet and learn from experts in the field
  • Learn by doing- participate in case studies and interactive sessions
  • Build a network to support the rest of your career
  • Understand the key aspects for successful variation application
  • Avoid the application common pitfalls 
  • Learn the best practice for national and MRP/DCP/centralised applications 
  • Take a course designed by professionals for professionals with a proven track record
CPD: This course provides 8 CPD hours upon successful completion

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.


Presenters

All TOPRA CRED courses are taught by experts with real-life, practical knowledge and experience. Past presenters for this course have included experts from TEVA, Biogen Idec, EMA and MHRA.

Suitable for

  • Regulatory Affairs Professionals writing reports and dossier sections
  • Related technical experts who write regulatory documents 

Pricing  

Book now at 2018 registration fees! 

Type Member Non-member 
Standard    £925+VAT  £1,095+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 
 £693.75+VAT
 £821.25+VAT
Those working for charities, patient groups or in full-time education
 £462.50+VAT  £547.50+VAT

*VAT, if applicable, is charged at the rate of 21%

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Next steps

When
12/06/2019 - 13/06/2019
Where
TOPRA Ltd 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
Your VAT country
Your Vat number
NOTE
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Register now