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AI Regulation in Pharmacovigilance. REGULATORY BRIEFING 2026
Over the last year, something shifted. The EMA–FDA joint Good AI Practice Principles (Jan 2026), the CIOMS Working Group XIV final report (Dec 2025), and the EU AI Act high-risk rules taking effect this August have moved AI in PV from "interesting pilot" to "regulated...
ICH Quality Risk Management as part of Integrated Quality Management
This presentation relates to Annex II.1 of ICH Q9(R1) To ensure the adequate management of risks and continuous improvement, it is essential for the principles and practices of QRM to be fully integrated within the PQS as outlined by ICH Q9 (R1). • ICH Q9 (R1) is not...
FDA Examples of Real-World Evidence Used in Medical Device Regulatory Decisions
This report presents 73 examples of market authorizations from fiscal years (FY) 2020-2025 building on the foundational work presented in the 2021 publication “Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions,” which documented 90...
FDA eMDR – Electronic Medical Device Reporting
Update: April 10, 2026 The FDA has updated its Electronic Medical Device Reporting (eMDR) framework, confirming the transition to the ESG NextGen Unified Submission Portal As of April 14, 2025, the ESG NextGen portal replaces the legacy WebTrader interface, providing...
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