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Compiling Successful Clinical Trial Applications

Price

£1,095*

Location

London, UK

Date

14 Nov 2018

Reference No: T1803291-TOP

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Event Description

Course Outline:

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

When & Where?

When:
14 November 2018 - 15 November 2018

Where:
TOPRA, 6th Floor
3 Harbour Exchange 
South Quay
London, E14 9GE

*Cost?

TOPRA Member: £1,095 plus 20% VAT
TOPRA Non-member: £925 plus 20% VAT

Applicant Requirements
  • Less experienced Regulatory Professionals who require comprehensive information on a subject
  • Experienced professionals who is a newcomer to a particular regulatory aspect
  • Anyone who wishes to update their knowledge in a particular subject area
Reference No: T1803291-TOP
TOPRA is the professional membership organisation for individuals working in healthcare regulatory affairs.
We work with our members internationally to enable and promote excellence across the healthcare regulatory profession.

Email info@topra.org

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