Insights from
UBC's Expert Voices

As Real World Evidence (RWE) continues to shape regulatory decision-making, the FDA and Duke Margolis Institute convened a public meeting to share successes, challenges, and lessons learned in RWE submissions. With over 4,000 attendees, the event spotlighted case studies, data feasibility, and the evolving role of RWE in labeling, post-marketing commitments, and registrational trials. Learn how sponsors are partnering with regulators to modernize study design and advance global RWE standards.

Pharmacies are essential to REMS—but manual processes and fragmented systems create risk and inefficiency. UBC’s RAPID API offers a secure, standards-based integration that streamlines REMS activities directly within pharmacy workflows. Learn how RAPID reduces burden, improves data quality, and elevates patient safety across the REMS ecosystem.

Designing a database study can be challenging with the proliferation of RWD availability and source diversity. Learn how to ensure that database feasibility assessments successfully identify the most relevant data sources appropriate for the evaluation of study objectives.

Patient engagement plays a central role in medication adherence, persistence, and retention. Explore how digital tools, including EHRs, electronic healthcare technology, and digital assistants, can contribute meaningfully to patient engagement.

Artificial intelligence is transforming pharmacovigilance—but human expertise remains essential. As AI systems evolve to support drug safety monitoring, ensuring human oversight is key to managing risk, improving outcomes, and maintaining trust. At UBC, we’re blending AI innovation with deep PV knowledge, empowering our teams through AI awareness training and shaping a safer future for patients. Discover how AI and humans can work together to advance pharmacovigilance.

UBC’s approach to real-world data tokenization and linkage enhances study results with longitudinal observation of various participant health outcomes during the pre-and post-trial period.

Linking longitudinal real-world data (RWD) to clinical study data offers deeper insights for drug developers. Contextualize study outcomes, extend data collection after the study ends, close the efficacy-effectiveness gap, and identify post-market patterns.

UBC Pharmacovigilance experts, Dobrochna Dolicka, Christopher Henry, Alix Garcia and Irene Navarro presented at DIA Europe 2025 on how AI can be used to streamline pharmacovigilance activities and how harmonization of guidelines can be enhanced in order to define a specific framework for gene therapy.

Psychedelic-assisted therapies are starting to emerge with potential as treatments for mental health conditions. Explore the evidence behind an increased interest in this use of substances such as psilocybin, MDMA, LSD, and DMT, and the future of research in this area.