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Understanding Clinical Development

Price

£1,095*

Location

London, UK

Date

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?

When:
27 June 2018 - 28 June 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 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.

Email info@topra.org

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