Start time day 1: 09:00 GMT |
End time day 2: 16:30 GMT
CPD: 14.5 CPD hours upon successful completion
Who should attend
This course is ideal 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
What you'll learn
By completing this course, you will be able to:
- 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.
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. – previous delegate
Course presenters
Course presenters include:
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.
Click here to check and validate your VAT number.
For EU countries; if you are unsure of the VAT number,
click here to check and validate your VAT number.
Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.