Online module 1 – Drug Development

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

3. 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

4. Health Economics

• Health economics advanced