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2022 Workshop report – How has the pandemic accelerated the acceptance and utility of RWD/RWE in regulatory/HTA decision making?

This workshop builds on the outcomes of the CIRS Professor Breckenridge memorial workshop in December 2020, as well as the 2021 workshop on utilisation of digital technologies in clinical [...]

Juan Lara2023-02-27T21:34:46+00:00February 27th, 2023|Tags: Health Technology Assessment, Real-world data/evidence, Regulatory, RWD/RWE|
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CIRS RD Briefing 85 – New drug approvals in six major authorities 2012-2021

This Briefing presents the results from the CIRS annual analysis of new active substance (NAS) approvals by six major regulatory agencies: the European Medicines Agency (EMA), the US Food [...]

Jenny Sharpe2022-06-28T08:17:34+00:00June 28th, 2022|Tags: Facilitated regulatory pathways, Real-world data/evidence, Regulatory, Work sharing|
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2016 Workshop report – RWD to RWE for assessing efficacy and effectiveness

Real-world data to real-world evidence for assessing efficacy and effectiveness: Opportunities and challenges for new medicines development, regulatory review and health technology assessment 23-24 JUNE 2016 TYSONS CORNER, VIRGINIA, [...]

Jenny Sharpe2021-12-24T13:33:18+00:00June 24th, 2016|Tags: Real-world data/evidence|
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  • Home
  • About
    • Mission
    • Governance
    • History
    • Meet the team
  • Research
    • Research strategy
    • Regulatory
      • Mature agency benchmarking
      • Regulatory strengthening (OpERA)
      • Growth & emerging markets metrics
    • HTA
      • HTA agency benchmarking
      • HTA industry metrics
      • Regulatory and Reimbursement Atlas
  • News
  • Publications
  • Membership
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