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.
Alexis Pinçon, MD
Director, Global Medical Services & Medical Writing
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.
AI isn't replacing pharmacovigilance professionals. It's changing how they work. Learn why the centaur model, where humans direct AI rather than defer to it, is emerging as the standard for regulated safety operations.
AI savings numbers are easy to put in a proposal. What's harder to find is what happens when something goes wrong. Here's a framework for pricing in the risk that vendor pitches leave out, plus four questions worth asking before you switch.
From triage to causality assessment, AI is changing how case processing teams work. We break down five areas where automation is making an impact, and the human expertise that still has to anchor every decision.
Psychedelic-assisted therapies are emerging as a promising frontier for treatment-resistant mental health conditions. As the regulatory landscape evolves, robust risk management frameworks will be critical to bringing these therapies safely to patients. UBC explores the current landscape and what approval pathways may mean for sponsors.
Automation and AI are often used interchangeably in PV, but they're built for different jobs. This piece breaks down where each one delivers value, and how to choose the right fit without adding unnecessary complexity.
AI is everywhere in PV conversations, but far less mature in practice. Here's what stood out from Why Summit: Future of PV: validation bottlenecks, signal inflation, and why the real challenge isn't technology.
Canada's consent-driven data silos and the U.S.'s regulatory patchwork aren't just administrative hurdles — they're determinants of bias in real-world evidence.
Implementing Regulation (EU) 2025/1466 is in full effect — and it's the biggest change to EU pharmacovigilance rules in over a decade. Here's what your compliance team needs to act on right now.
Bekki Bracken Brown serves as the President and CEO of UBC, guiding the company’s mission and values, including the improvement of access for patients to receive better outcomes. She oversees all aspects of UBC, such as operations, business growth strategy, sales and marketing, and acquisition support.
With over 20 years of industry experience, Ms. Brown brings knowledge from a successful career in senior management from her tenure at Quintiles, INC Research, and, most recently, with Syneos Health. She’s been a member of the North Carolina BIO Board of Directors since 2019. She is also a member of the Healthcare Businesswomen’s Association — Southeast Chapter and CHIEF, an organization that supports women executive leaders. Ms. Brown earned her bachelor’s degree at Duke University.