When: 23-24 June 2021
Where: Online
Start time day 1: 09:00 BST (GMT+1) | End time day 2: 16:00
Course overview
This course looks at the current requirements for an EU Clinical Trial Application (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 will also be reviewed with an update on its implementations. An agency speaker has been invited to give their 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.” – 2019 delegate
Benefits to delegates
- Understand the EU CTA and IMPD dossier
- Learn how to maintain your CTA
- Understand the Voluntary Harmonisation Procedure and the new 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.
Programme
Download a copy of the programme here.
Presenters
Suitable for
- Regulatory professionals with 2-5 years experience who require comprehensive information on clinical trials
- 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: £925+VAT*
- Non-member: £1,095+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: £693.75+VAT
- Non-members: £821.25+VAT
- Those working for charities, patient groups or in full-time education:
- Members: £462.50+VAT
- Non-members: £547.50+VAT
*VAT, if applicable, is charged at the rate of 20%
Terms and conditions
Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.