Critically Evaluating Dossiers

Critically Evaluating Dossiers
This course will help you critically analyse dossiers by understanding the importance of helping the assessor find pivotal information, as well as the importance of having consistent messages across Module 2, and between the summaries and the documents of Module 3-5.



When
: 19 September 2019
Where: TOPRA. 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE
Time: 09.00 - 17.00

Course overview

Find the balance in providing just the right amount of information to assure your dossier fits with your regulatory strategy and on-going compliance needs. This course will help you understand the critical attribute of QBD and CQA in pharmaceutical development, and the importance of development pharmaceutics in helping the pharmaceutical assessor, whilst minimising future life-cycle maintenance of the MAA dossier. 

Benefits to delegates

  • Learn by doing - Participate in case studies and interactive sessions 
  • Build a network to support the rest of your career
  • Meet and learn from experts in the field   
  • Take a course developed 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.

Programme

The latest course programme can be downloaded here.

Suitable for

Those who are responsible for reviewing dossiers for managers or for outsourced work and those involved in due diligence

Pricing  

Course *fees:
Type Member Non-member 
Standard    £550+VAT  £675+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 in full-time education
 £275+VAT  £337.50+VAT

*VAT, if applicable, is charged at the rate of 20%

Related courses

Next steps

When
19/09/2019
Where
TOPRA Ltd 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
Your VAT country
Your Vat number
NOTE
If your company 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

 

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