The landscape for the regulation of clinical trials in Europe is changing. This course will include the current
requirements for an EU Clinical Trial Application (CTA) and information on how
the introduction of the new clinical trial regulation will change things. The
course will also touch upon the requirements outside of the EU and also special
cases such as paediatrics and biotechnology products.
Who Should Attend?
- The less experienced Regulatory Professional who requires comprehensive information on a subject.
- The experienced professional who is a newcomer to a particular regulatory aspect.
- Anyone who wishes to update their knowledge in a particular subject area.
Day 1
Clinical Trial Applications: Overview and practical aspects.
- The Clinical Trial Application - overview and lifecycle and consideration of global clinical trials strategy.
- Overview of the EU CTA - initiation, maintenance and obligations.
- GCP and GCP inspections.
- The IMPD dossier - Preclinical, CMC, and clinical data requirement in support of each stage of clinical development.
Day 2
Strategic considerations for Clinical Trial Applications
- Consideration of clinical trials to support global development and clinical trials for specific circumstances.
- Clinical Trial Applications for Biotech Products.
- Conducting Paediatric clinical trials.
- Overview of the regulatory requirements for clinical trials in strategic markets such as US, India, China and others.
- Acceptability of global data to GCP.
Plus case study workshops on both days to reinforce lectures
Download the draft programme (subject to change)
To register, please log in or create an account
Course price (including VAT):
Member: £1,110
Non-member: £1,314
Those working for regulatory agencies or government agencies or academic institutions:
Member: £832.50
Non Member: £985.50
For the 25% discount please contact meetings@topra.org for the code.
Those working for charities, patient groups or in full time education:
Member: £277.50
Non Member: £328.50
For the 75% discount please contact meetings@topra.org for the code.
Please note the number of discounted places may be limited.
All fees are shown in Pounds Sterling and include VAT
- Fee excludes accommodation and travel.
- The delegate ticket includes refreshments at coffee breaks and buffet lunches (if applicable).
- All cancellations must be received in writing 28 calendar days before the start of the course and will be subject to an administration fee of £150 + GB VAT. We regret that registrations cannot be transferred to another course, however delegate substitutions may be made up to 10 working days before the course.