When: 25-26 February 2025
Start time day 1: 09:00 GMT / 10:00 CET
End time day 2: 16:45 GMT / 17:45 CET
Location: Online
Course overview
This course looks at the current requirements for Clinical Trial Applications (CTAs) in the EU, as well as some considerations in key countries outside the EU. The course also covers strategic considerations for CTAs in the context of Global Clinical Development. The EU Clinical Trial Regulation 536/2014 will be discussed in detail including current updates on Clinical Trial Information System (CTIS) . A Regulatory Agency speaker will provide a regulators’ 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.” – previous delegate
Benefits to delegates
- Understand the CTA process across all regions
- Learn how to maintain your CTA to remain compliant
- Learn by doing - actively participate in 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 course programme is available here.
Presenters
Presenters include:
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: £1,050+VAT*
- Non-member: £1,250+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: £787.50+VAT
- Non-members: £937.50+VAT
- Those working for charities, patient groups or in full-time education:
- Members: £525+VAT
- Non-members: £625+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.