Insights from
UBC's Expert Voices

Ask most people what inspection readiness means and you’ll hear about a scramble: pulling documents together, briefing colleagues, running mock inspections in the weeks before the real thing. That picture isn’t wrong, it’s just incomplete, and it puts the emphasis in the wrong place.

When the only view of the program is a static snapshot, the honest answer is often “we’ll know when the next report comes in.” That is the gap real-time dashboards close.

The documentation has never been the problem. The problem is accessing the right part of it quickly enough to support day-to-day operations.

On September 14, 2026, FDA convened a Part 15 hearing to discuss "Considerations for Potential Future Therapeutic Use of Psychedelic Drugs." The meeting was a compilation of 2 minute segments for 80 public commentators representing a diverse community of academia, patients, advocates, service providers, and industry.

Yes, automation can process volume. What it can't do is exercise clinical judgment on a case that doesn't fit the pattern, defend a causality assessment to a health authority inspector, or carry a program's institutional history from one reviewer to the next. Those are not workflow steps. They're physician functions.

The first oncology JCA reports show that this new EU assessment process is anything but routine. Here's what sponsors can learn from early submissions, and how to prepare for what's ahead.

The question for Patient Services leaders isn't automation vs. AI. It's knowing where each capability creates value, where it introduces risk, and how to build both into a stronger service model.

The story of patient access this year is really two stories that meet in the same place. The first is structural: the insurance landscape is being rebuilt, reshaping how pharmacy benefits are paid for, how long people keep coverage, and what a marketplace plan covers. The second is where patients feel it.

With immature survival data, single-arm trials, and limited comparators common in early JCA submissions, real-world evidence is becoming a strategic necessity, not an afterthought. Learn how sponsors can plan and generate RWE that meets the methodological bar EU assessors expect.