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EU | ICH M14 Guideline on Non-Interventional Studies Using RWD Becomes Legally Effective — Implications for EU Pharmacovigilance Practice

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EU | ICH M14 Guideline on Non-Interventional Studies Using RWD Becomes Legally Effective — Implications for EU Pharmacovigilance Practice2026-02-16T10:11:05+00:00

EU | Updates to Regulation (EU) No 520/2012 — Key Pharmacovigilance Changes Applicable from 12 February 2026

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EU | Updates to Regulation (EU) No 520/2012 — Key Pharmacovigilance Changes Applicable from 12 February 20262026-02-16T09:57:38+00:00

ITALY | AIFA Adds New RSO Functionalities to Align with 2024 Observational Study Guidelines

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ITALY | AIFA Adds New RSO Functionalities to Align with 2024 Observational Study Guidelines2026-01-09T12:36:06+00:00

INDIA | Digital Personal Data Protection (DPDP) Rules 2025 – Implications for Real-World Research

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INDIA | Digital Personal Data Protection (DPDP) Rules 2025 – Implications for Real-World Research2025-12-07T15:20:36+00:00

BRAZIL | Decree No. 12,651 (2025) Establishes the National System of Ethics in Research with Human Beings

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BRAZIL | Decree No. 12,651 (2025) Establishes the National System of Ethics in Research with Human Beings2025-11-09T09:35:31+00:00

CZECH REPUBLIC | Cybersecurity Act Implements NIS2 — New Compliance Obligations for Health Research

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CZECH REPUBLIC | Cybersecurity Act Implements NIS2 — New Compliance Obligations for Health Research2025-09-10T10:11:28+00:00
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