Module 5: Global Registration and Approval Process

Overview on mechanisms and regulatory management systems in Europe, the USA and Asia. Requirements of a regulatory application, documentation and collaboration between developers and regulators. Special regulatory procedures, strategies and crisis management.

Key topics

  • Regulation of pre- and post-approval of medicines at EU and global level
  • Regulatory activities within a pharmaceutical company
  • National and international bodies responsible for medicines regulation and their procedures
  • Off-label / unlicensed use of medicines
  • International Conference on Harmonisation (ICH)
  • Special Interest Area Community (SIAC)
  • Pharmacovigilance: Classification of adverse events / reactions
  • Safety reporting requirements pre- and post-approval
  • benefit / risk assessment and pharmacoepidemiology throughout the lifecycle of a medicine

Learning Outcomes

At the end of this module the students should be able to describe the:

  1. General principles of medicines and medical devices regulation (both pre- and post-approval)
  2. Principles and management of drug safety and pharmacovigilance
  3. Role of pharmacoepidemiology in the lifecycle management of a medicine