Online module 1 – Drug Development

Teaching staff

PharmaTrain Federation

07 Dec 2020 - 31 Jan 2021
PharmaTrain Federation e-learning platform

Description

On demand original series of 4 chapters organised in 19 learning sections on ‘Drug development’ provided by PharmaTrain Federation (TRIM-NET Partner Organisation 1):

  1. Overview Medicines Development
  • The context
  • Drug Discovery
  • Clinical Trials
  • Ethics and GCP
  • Introduction Regulatory affairs
  • Introduction Health economics

     2. The Optimal Dose Masterclass

  • Introduction
  • Safety and efficacy
  • Variability
  • Dose-response relationship
  1. Registration of Medicinal Products
  • Historical Background
  • International Scenario
  • The European regulatory environment
  • Interactions throughout drug development
  • Licence types and application procedures
  • The Clinical Trial Directive and the role of International Committee on Harmonisation
  • Licence maintenance and variations
  • Summary of Product Characteristics
  1. Health Economics
  • Health economics advanced