Compiling Successful Clinical Trial Applications

Compiling Successful Clinical Trial Applications
Gain a clear understanding of Clinical Trial Application (CTA) requirements across the EU and beyond, including the latest updates on the EU Clinical Trial Regulation 536/2014 and CTIS. Learn practical strategies for managing CTAs effectively through expert-led, interactive sessions.

This course is also available to attend online.



When:
  2 - 3 June 2027
Where: TOPRA 3rd Floor, City Reach, 5-6 Greenwich View Place, London, E14 9NN
Start time day 1:  09:00 BST |  End time day 2: 16:30 BST
CPD: 15.5 CPD hours upon successful completion

Who should attend

This course is ideal for:

  • Less experienced regulatory professional seeking a comprehensive understanding of clinical development
  • Experienced professionals who are new to this area or wish to refresh their knowledge
  • Individuals from regulatory, medical, clinical and safety functions involved in phase I, II, III and IV trials

What you'll learn

By completing this course, you will be able to:

  • Optimise a clinical development programme to support a successful marketing application
  • Design clinical trials that demonstrate proof of efficacy
  • Apply key principles of clinical pharmacokinetics and pharmacodynamics to inform dose selection and study design
  • Select and justify optimal study designs across different stages of clinical development
  • Understand the role and requirements of Paediatric Investigation Plans

 

Course overview

This course provides an overview from regulators and industry on the process of designing and conducting clinical trials during phases I, II and III. It covers the main considerations for devising a clinical development programme, including clinical pharmacokinetics and pharmacodynamics, study design, paediatric requirements and safety, to support a marketing application and beyond.

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Course presenters

The expert presenters for this course will be announced soon.

    Pricing

     Standard training course registration fees
     Event Registration Type Price (GBP)
     Standard Price 
     TOPRA Member
    £1,250.00 + VAT*
     Standard Price
     Non-member
    £1,750.00 + VAT* 







     
    Those working for regulatory or government agencies, academic institutions, charities, patient groups, emerging markets, and MSEs (Micro and Small Enterprises) can also access discounted rates by becoming a TOPRA member. For more information about the discounts available, please email meetings@topra.org before making your booking. 

    Important Notice On VAT

    In compliance with regulations, a *20% VAT will be charged to all attendees, regardless of your country of origin. If you have a VAT number or if the company or organisation you are affiliated with has a VAT number or equivalent please ensure it is visible on your profile. If your VAT number is not visible on your profile, please email finance@topra.org to have it updated. If you do not have a VAT number, there is no action required — VAT will be applied accordingly during the registration process. Please observe that the VAT number needs to be valid.

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    Terms and conditions

    By booking a place on this course you are agreeing to the Training Terms and Conditions.

     
    When
    02/06/2027 - 03/06/2027
    Where
    TOPRA 3rd Floor City Reach 5 Greenwich View Place London E14 9NN UNITED KINGDOM
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