The Committee for Advanced Therapies: A Missed Opportunity for Industry Engagement in 2026
The announcement of the Committee for Advanced Therapies (CAT) meeting scheduled for January 21-23, 2026, at the European Medicines Agency in Amsterdam is, on the surface, a routine event in…
EMA’s Veterinary Medicines Info Day 2026: A Missed Opportunity for Industry Innovation and Engagement
The European Medicines Agency’s decision to host the Veterinary Medicines Info Day in a purely online format reflects both the evolving digital landscape and a cautious approach to stakeholder engagement.…
Passwordless Authentication: Healthcare IT’s Top Priority That Remains Elusive
The recent survey by Imprivata highlighting the enthusiasm among healthcare IT leaders for passwordless authentication is both unsurprising and deeply telling. It underscores a growing awareness that traditional password-based security…
EMA’s Upcoming Q&A Clinic Signals Growing Complexity in Regulatory Substance Management—Are Pharma Marketers Ready?
The European Medicines Agency’s decision to host a live Q&A clinic focused on Substance, Organisation, and Referential Management Services is more than a routine informational session—it’s a clear signal of…
EMA’s 2026 Product Management Service Day: A Missed Opportunity for Deeper Industry Engagement
The European Medicines Agency’s decision to host the Product Management Service (PMS) information day as a half-day online broadcast is emblematic of the ongoing tension between accessibility and depth in…
PRAC’s January 2026 Meeting: A Critical Juncture for Pharmacovigilance Strategy in Europe
The upcoming Pharmacovigilance Risk Assessment Committee (PRAC) meeting scheduled for January 12-15, 2026 at the European Medicines Agency in Amsterdam represents more than just a routine regulatory checkpoint—it is a…
The Regulatory Risk-Classification Trap: Why Over-Compliance Is Killing Innovation and Efficiency
The pervasive industry tendency to over-classify medical devices under higher risk categories is not just a benign over-cautiousness—it is a strategic failure that undermines the very purpose of risk-based regulation.…
PathoCare’s $1.75 Billion Valuation Signals Shifting Dynamics in Medical Diagnostics Investment
PathoCare Holdings’ recent announcement of a $1.75 billion valuation via a private third-party tender offer is more than just a financial milestone—it’s a clear indicator of evolving investor confidence in…
Why Medical Device PMS Must Break Free from Pharmaceutical Pharmacovigilance Paradigms
The persistent conflation of medical device and IVD Post-Market Surveillance (PMS) with pharmaceutical pharmacovigilance (PV) is a fundamental misunderstanding that continues to plague regulatory compliance and quality management in our…
2025’s Medtech Shakeup Sets the Stage for a Turbulent 2026
The medical device industry is at a pivotal crossroads as we look toward 2026, and the seismic shifts in 2025 are more than just fleeting headlines—they are harbingers of a…