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  SAUDI ARABIA | SFDA Issues Draft RWE Framework

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  SAUDI ARABIA | SFDA Issues Draft RWE Framework

  2025, August 2025, Members-Only, Minor Update, RWD to Support Reg Decisions, Saudi Arabia, Secondary Use of Existing Data
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SAUDI ARABIA | SFDA Issues Draft RWE Framework

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SAUDI ARABIA | SFDA Issues Draft RWE Frameworkstuart.mccully2025-09-10T10:49:06+00:00

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  EU | Launch of GREG: A Landmark Initiative to Strengthen RWE Practices

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  EU | Launch of GREG: A Landmark Initiative to Strengthen RWE Practices

  2025, August 2025, EU, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data
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EU | Launch of GREG: A Landmark Initiative to Strengthen RWE Practices

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EU | Launch of GREG: A Landmark Initiative to Strengthen RWE Practicesstuart.mccully2025-09-10T10:43:30+00:00

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  EU | Updates From Latest EMA Report on Regulator-Led Studies Using RWD

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  EU | Updates From Latest EMA Report on Regulator-Led Studies Using RWD

  2025, June 2025, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data
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EU | Updates From Latest EMA Report on Regulator-Led Studies Using RWD

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EU | Updates From Latest EMA Report on Regulator-Led Studies Using RWDstuart.mccully2025-07-08T14:43:21+00:00

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  UK | MHRA Releases Draft Guidance on Using Real-World Data for External Control Arms in Clinical Trials

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  UK | MHRA Releases Draft Guidance on Using Real-World Data for External Control Arms in Clinical Trials

  2025, May 2025, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, UK
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UK | MHRA Releases Draft Guidance on Using Real-World Data for External Control Arms in Clinical Trials

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UK | MHRA Releases Draft Guidance on Using Real-World Data for External Control Arms in Clinical Trialsstuart.mccully2025-06-09T08:47:30+00:00

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  EU | HealthData@EU Central Platform: Release 4

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  EU | HealthData@EU Central Platform: Release 4

  2025, EHDS, EU, May 2022, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data
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EU | HealthData@EU Central Platform: Release 4

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EU | HealthData@EU Central Platform: Release 4stuart.mccully2025-06-09T08:30:30+00:00

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  EU | Use of RWD in NIS to Generate RWD to Generate RWE for Regulatory Purposes

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  EU | Use of RWD in NIS to Generate RWD to Generate RWE for Regulatory Purposes

  2025, April 2025, EMA, EU, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data
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EU | Use of RWD in NIS to Generate RWD to Generate RWE for Regulatory Purposes

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EU | Use of RWD in NIS to Generate RWD to Generate RWE for Regulatory Purposesstuart.mccully2025-05-04T15:28:44+00:00

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  EU | European Health Data Space Regulation Adopted by the European Council

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  EU | European Health Data Space Regulation Adopted by the European Council

  2025, AI, EHDS, EU, January 2025, Members-Only, November 2021, Secondary Use of Existing Data, Significant Update
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EU | European Health Data Space Regulation Adopted by the European Council

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EU | European Health Data Space Regulation Adopted by the European Councilstuart.mccully2025-02-06T11:19:12+00:00

EU | Real World Data Quality Framework (RW-DQF): Public Consultation

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EU | Real World Data Quality Framework (RW-DQF): Public Consultationstuart.mccully2025-01-02T18:00:16+00:00

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  JAPAN | PMDA Perspective on RWD and RWE USE for Regulatory Purposes

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  JAPAN | PMDA Perspective on RWD and RWE USE for Regulatory Purposes

  2024, Japan, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data
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JAPAN | PMDA Perspective on RWD and RWE USE for Regulatory Purposes

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JAPAN | PMDA Perspective on RWD and RWE USE for Regulatory Purposesstuart.mccully2024-11-06T17:53:35+00:00

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  EU | EMA Guidance – Harnessing AI in Medicines Regulation: Use of Large Language Models (LLMs)

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  EU | EMA Guidance – Harnessing AI in Medicines Regulation: Use of Large Language Models (LLMs)

  2024, AI, EMA, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data
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EU | EMA Guidance – Harnessing AI in Medicines Regulation: Use of Large Language Models (LLMs)

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EU | EMA Guidance – Harnessing AI in Medicines Regulation: Use of Large Language Models (LLMs)stuart.mccully2024-11-06T17:36:10+00:00