14 Nov 2018
Reference No: T1803291-TOPApply for this event
A two-day course looking 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 will also include information on strategic considerations for CTAs and clinical development, and will on touch on special cases such as first in man studies and paediatrics.
The new EU Clinical Trials Regulations will be reviewed, including some of the key changes that we might expect to see as a result of this. A Regulatory Agency speaker has been invited to give their perspective on common issues and hot topics associated with CTAs.
The course will cover an overview of the EU CTA and the IMPD dossier and how to maintain your CTA, the Voluntary Harmonisation procedure, the new Clinical Trial Regulation and a case study workshop to reinforce the lectures
14 November 2018 - 15 November 2018
TOPRA, 6th Floor
3 Harbour Exchange
London, E14 9GE
TOPRA Member: £1,095 plus 20% VAT
TOPRA Non-member: £925 plus 20% VAT