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Course summary
2 days
1,095 GBP excl. VAT
English
London
Next available date: 10/06/2020 09:00 - London

Course description

Understanding Clinical Development

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 pharmacokinetics
  • Clinical Pharmacodynamics
  • Optimal study design
  • Paediatric Investigation Plans
  • Safety

Suitability - Who should attend?

Suitable for

  • 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.

Outcome / Qualification etc.

Benefits to participants

  • Meet and learn from experts in the field from both industry and agency
  • Learn by doing - participate in case studies and interactive sessions
  • Build a network to support the rest of your career
  • An opportunity to ask questions and have an open discussion with speaker and participants
  • Optimise your clinical development programme
  • Design clinical trials to support proof of efficacy

Training Course Content

Day One

  • Clinical Development in Context
  • Clinical Pharmacokinetics
  • Clinical Pharmacodynamics
  • Optimal Study Design – Objectives and Issues Relating to Phase II studies
  • Paediatric Investigation Plans

Day Two

  • Design of Clinical Trials to Support Proof of Efficacy (Phase III)
  • Safety
  • The Perspective of a Regulatory Authority Reviewer

Expenses

The full tuition price for Members is 925 GBP. The price for Non-members is 1095 GBP

About provider

The Organisation for Professionals in Regulatory Affairs

The Organisation for Professionals in Regulatory Affairs (TOPRA)

The Organisation for Professionals in Regulatory Affairs (TOPRA) has encouraged excellence in the area of regulatory affairs for pharmaceuticals, veterinary medicines and medical devices since 1978. TOPRA's mission is to represent and promote the profession of healthcare regulatory affairs globally....


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Contact info

The Organisation for Professionals in Regulatory Affairs

3 Harbour Exchange, 6th Floor
E14 9GE London

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