Compiling Successful Clinical Trial Applications

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

When
: 7-8 February 2023
Start time day 1: 09:00 GMT / 10:00 CET
End time day 2: 17:00 GMT / 18:00 CET 
Location: Sheraton Brussels Airport, 1930 Brussel, Belgium 

Also available as an online course, please click here for the online registration option.

Course overview
This course looks at the current requirements for Clinical Trial Applications (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. The new EU Clinical Trials Regulation 536/2014 will be discussed with an update on its progress since the Clinical Trial Information System (CTIS) . An agency speaker has been invited to give their perspective on common issues and hot topics associated with CTAs.

It was a great course, very informative and useful to my day to day job as a regulatory professional working in a CRO. A lot of thought and consideration went into the content. Particularly enjoyed the discussion with the Swedish Regulator.”  – 2019 delegate

Benefits to delegates

  • Understand the CTA process
  • Learn how to maintain your CTA
  • Understand the difference between the Clinical Trial Directive and the 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.

Programme

The programme is available here.

Accommodation 

Preferential rates for delegates are available at the Sheraton Brussels Airport Hotel. Please e-mail meetings@topra.org after booking the course for information on how to access it.

Presenters

Previous presenters have included: 

Suitable for

  • Regulatory professionals with 2-5 years experience
  • Experienced professionals who are newcomers to clinical trials in a regulatory function 
  • Anyone who wishes to update their knowledge in this subject area

Pricing

Standard

  • Member: £925+VAT*
  • Non-member: £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:
    • Members: £693.75+VAT
    • Non-members:  £821.25+VAT
  • Those working for charities, patient groups or in full-time education:
    • Members: £462.50+VAT
    • Non-members: £547.50+VAT 
*VAT, if applicable, is charged at the rate of 20%

Terms and conditions

By booking a place on this course you are agreeing to the training terms and conditions.

When
07/02/2023 - 08/02/2023
Where
BRUSSELS BELGIUM
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