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.

When
: 7-8 February 2024
Location: Prague, Czech Republic 
Where: Vienna House by Wyndham Andel's

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.

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.

Accommodation 

There is a limited availability for participants to book their accommodation at the Vienna House by Wyndham Andel's. Send an email to meetings@topra.org with your request. 

Programme

Download programme here. 

Presenters

Presenters included:
  • Pierre Omnes, TransPerfect
  • Shaila Choi, Seagen
  • Matthew Scullion, Janssen
  • Stephen Thompson, S Cubed
  • Bob Ibbotson, Shionogi BV 

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  

Simply log in or create an account and register below.
Type Member Non-member 
Standard    £955+VAT  £1,130+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 
 £716.25+VAT
 £847.50+VAT
Those working for charities, patient groups or in full-time education
 £477.50+VAT  £565+VAT

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

Terms and conditions

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

 

When
07/02/2024 - 08/02/2024
Where
PRAGUE CZECH REPUBLIC
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