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PiVily Reports · A flagship Pulse format

The pharmacovigilance quarter, in context.

A source-led record of the regulatory, evidence, technology, governance, and professional-capability shifts changing how pharmacovigilance is practiced.

Facts link to official publishers. PiVily interpretation and future watchpoints are identified separately.

Current flagship synthesisQ3 2026

State of the pharmacovigilance ecosystem

The State of the Pharmacovigilance Ecosystem

A baseline synthesis of the six connected shifts shaping the field from January 2025 through 11 August 2026.

This launch edition establishes a broader baseline across multiple quarters. The archive below records what changed within each individual quarter.

Read the current synthesis Request a briefing or conversation
Quarterly reportsWhat changed this quarter.

A period-specific, source-led record published as part of PiVily Pulse.

State of the Pharmacovigilance EcosystemA broader periodic synthesis.

A flagship view that connects patterns and shifts across multiple quarters.

January 2025–present

Read the record quarter by quarter.

Retrospective editions rebuild the record from official materials available for that period. They are labelled so publication timing is never confused with the timing of the underlying change.

2026

Current reporting year
Q1Governance became visible in the toolsCommon AI principles, a unified FDA adverse-event platform and more actionable real-world data quality guidance made governance concrete.Retrospective edition
8 min Q2Scale stopped being theoreticalRegulatory networks published evidence of operating scale in real-world data and AI, raising the standard for governance, capability and useful interpretation.Retrospective edition
7 min Q3The State of the Pharmacovigilance EcosystemA baseline synthesis of the six connected shifts shaping the field from January 2025 through 11 August 2026.Current edition
14 min
Q4October–December 2026Published after the quarter closes and the official-source review is complete.Upcoming
Q1Operating models, AI credibility and the long data horizonThe quarter made one operating reality harder to ignore: future-ready safety systems would depend on regulatory translation and governance as much as new technology.Retrospective edition
7 min Q2The evidence infrastructure took shapeRegulatory ambition around data and AI became more operational, while real-world evidence guidance focused attention on methods, transparency and the question a dataset can actually answer.Retrospective edition
6 min Q3Standards caught up with the operating realityGlobal ICSR and real-world evidence standards advanced while EU guidance sharpened expectations around privacy and embryo-fetal risk minimisation.Retrospective edition
8 min Q4Implementation and accountability moved to the foregroundThe quarter turned completed standards into an implementation agenda and reinforced that postmarketing reporting accountability follows the work across organisational boundaries.Retrospective edition
6 min

Editorial method

Built for scrutiny, not speed.

Each edition selects developments for their system-level relevance to pharmacovigilance and interprets why they matter across the field. It is designed as a sourced synthesis, not a jurisdiction-specific regulatory tracker.

  • Official sources remain one click away.
  • Source facts and PiVily interpretation are separated.
  • Leadership questions surface the practical implications.
  • Watchpoints are framed as questions, not predictions.
Read the editorial standard Find official pharmacovigilance resources

Briefings · Speaking · Partnerships

Bring the field into sharper focus.

PiVily works with educational institutions, professional associations, global initiatives, event hosts, media, and aligned partners to translate emerging pharmacovigilance developments into relevant, audience-specific context.

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