CIRS Agenda_2015

Global Development Programme

This workstream is designed to address the challenges posed by the need to align global submissions, and to fulfil requirements for regulatory reviews across mature and developing jurisdictions.

Strategic mission

  • Provide a neutral forum for the evolution of the global regulatory environment by facilitating the advancement of regulatory science concepts, methodologies and policies that improve the effectiveness, efficiency and decision making of companies and regulatory agencies in the development of safe and effective new medicines
  • Build trust between stakeholders as the key to facilitate change to enhance predictability, transparency, timeliness and quality
  • Achieve an internationally accepted approach for the systematic, routine and standardised documentation of decision making in the benefit-risk assessment of medicines
  • Identify procedures and practices that are required for timely, predictable, transparent and high-quality drug development and regulatory review
  • Assess quality of decision-making processes in regulatory science by individuals and organisations in drug development and regulatory review
  • Describe best practices amongst stakeholders through science-based insight and recommendations to facilitate good regulatory practices

Activities

  • Workshops: Well-received meetings on timely topics in regulatory science, informed by the real-world needs of member companies and participating regulatory agencies in emerging and¬†mature pharmaceutical markets
  • Regulators Fora: Platforms for discussion among regulatory agencies to facilitate sharing views and approaches to changes in the regulations of new medicines
  • Focus Studies: Research studies focusing on specific areas of interest within the local and regional regulatory environments
  • Insights Seminars: Interactive fora for member companies and agencies to focus on regulatory, health technology assessment and emerging market novel topics as well as to extend learnings from CIRS research and Workshops to all members of staff
  • Agency benchmarking: The Regulatory Review Times Database tracks application and approval dates for approved NASs at six agencies (US FDA, EMA, PMDA, Health Canada, TGA and Swissmedic).