Who should attend

• 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

What you'll learn

• Understand current Clinical Trial Application (CTA) requirements in the EU and key countries outside the EU
• Apply strategic considerations for CTAs within a global clinical development plan
• Interpret and comply with the EU Clinical Trial Regulation (CTR) 536/2014, including updates on the Clinical Trial Information System (CTIS)
• Recognise common regulatory issues and hot topics through insights from experienced regulators
  
  

Course overview

The process of managing Clinical Trial Applications (CTAs) can appear complex, especially for those new to it. This course provides clear guidance on current CTA requirements within the EU and other key jurisdictions. The EU Clinical Trial Regulation 536/2014 is explored in detail, including the latest updates on the Clinical Trial Information System (CTIS).

Through interactive sessions, case studies, and discussions with regulatory experts, you’ll gain practical insight into global CTA strategy and compliance. Developed by professionals for professionals, this course offers both valuable knowledge and the opportunity to connect with peers across the industry.

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Course presenters

 
 

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
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Terms and conditions

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