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Understanding Clinical Development




London, UK


27 Jun 2018 - 28 Jun 2018

Reference No: T1803287-TOP

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Event Description

Course Outline?

The aim of this practical workshop is to enable all those involved in medicines development to gain an appreciation of the points to consider when designing a clinical development programme to support a marketing application and also that clinical development extends beyond the marketing application
This course will cover:

  • Clinical Development in Context
  • Clinical Pharmacodynamics
  • Clinical Pharmacokinetics
  • Optimal Study Design – Objectives and Issues Relating to Phase II studies
  • Paediatric Investigation Plans
  • Safety
  • Design of Clinical Trials to Support Proof of Efficacy (Phase III)
  • The Perspective of a Regulatory Authority Reviewer

When & Where?

27 June 2018 - 28 June 2018

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


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

Applicant Requirements
  • Less experienced regulatory professional who requires comprehensive information on this subject
  • Experienced professional who is a newcomer to this subject
  • Those who wishes to update their knowledge on this subject
  • Persons from regulatory, medical, clinical and safety functions involved in phase I, II, III and IV trials
Reference No: T1803287-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.


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