Compiling Successful Clinical Trial Applications

Compiling Successful Clinical Trial Applications
This course will equip you with the key knowledge on Clinical Trials applications you need as a regulatory professional.

: 19-20 June 2019
Where: TOPRA. 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE
Day 1: 09.00 - 16.45
Day 2: 09.00 - 16.30  

Course overview

This course looks at the current requirements for an EU Clinical Trial Application (CTA), as well as some of the requirements in key countries outside the EU. It also includes information on strategic considerations for CTAs and clinical development, and includes special cases such as first in man studies and pediatric trials. The EU Clinical Trials Regulations will be reviewed, including some of the key changes that was introduced. An agency speaker has been invited to give their perspective on common issues and hot topics associated with CTAs.

Benefits to delegates

  • Understand the EU CTA and IMPD dossier 
  • Learn how to maintain your CTA
  • Understand the Voluntary Harmonisation procedure and the new Clinical Trial Regulation 
  • 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 14.5 CPD hours upon successful completion

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


The latest programme can be downloaded here.

Past presenters include 

All TOPRA CRED courses are taught by experts with real-life, practical knowledge and experience. This course has included expert from GSK, PRA Health, Janssen and Syneos Health.

Suitable for

  • Less experienced regulatory professionals who require comprehensive information on clinical trials 
  • Experienced professionals who are newcomers to clinical trials in a regulatory function 
  • Anyone who wishes to update their knowledge in this subject area 


Book now at 2018 registration fees! 

Course *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 for a discount code before making your booking.

Those working for regulatory agencies, government agencies or academic institutions 
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 20%

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19/06/2019 - 20/06/2019
TOPRA Ltd 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
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