Regulators, industry experts to present case studies and discuss latest advancements in safety monitoring and data analysis

DIA, a global non-profit organization of life sciences professionals, will examine the integration of artificial intelligence (AI) in safety workflows and the impact of real-world evidence (RWE) during its annual Global Pharmacovigilance and Risk Management Strategies Conference, which will be held from Jan. 27 to Jan. 29 in Baltimore.

Recent developments in AI and RWE have created opportunities to enhance patient safety monitoring and strengthen regulatory decision-making. The conference will examine these advances through practical demonstrations, including insights from the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIV on AI applications in literature review and signal detection. Sessions will also explore how pharmaceutical companies are successfully integrating RWE into regulatory submissions and post-marketing commitments, with case studies spotlighting improved safety outcomes.

"The life sciences industry has demonstrated how integrating AI and RWE into pharmacovigilance and risk management strategies can substantially improve patient outcomes," said Marwan Fathallah, DIA's President and Chief Executive Officer. "This conference creates opportunities for regulators and industry professionals to develop practical strategies for implementing these technologies while maintaining our commitment to safety and data quality."

Experts from Pfizer, GSK, Takeda, and Swedish Orphan Biovitrum (SOBI) will share case studies that show how their organizations are implementing AI and RWE. These presentations will examine successful approaches to automated literature case extractions, enhanced signal detection, and improved decision-making processes. Government officials, academics, innovators, and patients will also share their perspectives on how these approaches can strengthen pharmacovigilance practices.

In addition, representatives from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) will provide regulatory updates such as policies and guidance from emerging markets, TransCelerate pharmacovigilance initiatives, and the latest global harmonization activities.

The conference will feature several timely discussions. One session will focus on the FDA's latest draft guidance on data monitoring committees (DMCs) in clinical trials, including methods for evaluating potential safety signals. Back-to-back sessions on risk convergence will cover developments in risk evaluation and mitigation strategy (REMS) programs and additional risk minimization measures (aRMMs). Attendees will also have the opportunity to explore how small pharmaceutical companies can build effective pharmacovigilance frameworks despite resource limitations.

"This year's agenda is a direct response to what our members told us they needed," said Sorcha McCrohan, DIA's Scientific Project Manager. "With safety monitoring becoming more advanced, these sessions will help organizations find practical strategies for adopting new technologies while staying aligned with international standards."

The conference will be held at the Hilton Baltimore Inner Harbor. To register or view the program, visit https://www.diaglobal.org/en/conference-listing/meetings/2025/01/global-pharmacovigilance-and-risk-management-strategies-conference. Media members can request credentials by emailing diaglobal@gregoryfca.com.

About DIA

DIA is a leading global non-profit life science membership association that drives collaboration in drug, device, and diagnostics development in pursuit of a healthier world. Founded in 1964 with headquarters in Washington, D.C., and offices in Europe and Asia, DIA provides unparalleled networking opportunities, educational resources, scientific research publications, and professional development programs to members in more than 80 countries.

Learn more at DIAglobal.org, and connect with DIA on LinkedIn, Facebook, X (Twitter), and Instagram.

Media Contact Denise DiMeglio Gregory FCA denise@gregoryfca.com 610-228-2102