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 covers information on strategic considerations for CTAs and clinical development, including special cases such as first in man studies and paediatric trials. The new EU Clinical Trials Regulation will also be reviewed with an update on its implementations. 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
  • Meet and learn from experts in the field
  • Build a network of colleagues to support the rest of your career
  • Take a course developed by professionals for professionals — with a proven track record 
CPD: This course provides 14.5 CPD hours on successful completion

To learn more about why continuing professional development is important, visit our Lifelong Learning page.


The latest programme can be downloaded here.


Suitable for

  • Regulatory professionals with 2-5 years experience 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 


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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On occasions, TOPRA takes photographs and videos which may be used to help promote our conferences and courses (both online and in print). By purchasing a ticket to attend this meeting you are confirming that you are aware of this and have no objections to your image or voice appearing in any material issued by TOPRA after the meeting.

However, if for any reason you do not wish TOPRA to use your image or voice please let us know

Recording and photography by delegates is not permitted.