The EMA and Related European Regulatory Bodies: Exploring Their Unique Roles, Interplay, and Significance to the Global Pharmaceutical Industry

June 25, 2020 8:15am

  • The EMA: origins, creation and purpose vis-à-vis the principles and structure of the EU
    • Harmonization
  • Understanding how the EMA fits into the legal and regulatory structure of the European Union
  • Analyzing the EMA’s structure, organization and authority
    • Supra-national agency as opposed national agency
    • Defining EMA: a decentralized scientific agency
    • The EMA’s organization – Secretariat (management board); scientific committees; and scientific working parties
    • Exploring the seven scientific Committees and their roles/responsibilities
      • – Committee for Medicinal Products for Human Use (CHMP)
      • – Committee for Medicinal Products for Veterinary Use (CVMP)
      • – Committee for Orphan Medicinal Products (COMP)
      • – Committee on Herbal Medicinal Products (HMPC)
      • – Pediatric Committee (PDCO)
      • – Committee for Advanced Therapies (CAT)
      • – Pharmacovigilance Risk Assessment Committee (PRAC)
    • Regulatory authority as opposed to enforcement
    • Authority over medicinal products as opposed to devices
  • Identifying and analyzing significant regulations, directives and decisions affecting the EMA
  • Understanding the EMA’s role vis-à-vis other pharmaceutical regulatory bodies in Europe
  • Review of powers and authorities each member state retains aside from EMA’s centralized authority
    • Member state enforcement powers
    • Overview of key European pharmaceutical regulatory agencies
      • – MHRA (UK)
      • – BfArM/PEI (Paul-Ehrlich-Institut) (Germany)
      • – Affsapps (France)
      • – Sweden (MPA)
      • – Ireland (IMB)
      • – Swissmedic (Switzerland)
  • The Heads of Medicines Agency: purpose, scope and function