Global Pharmacovigilance and Risk Management Strategies Conference

Enjoy a networking lunch while participating in a focused roundtable discussion. Select a topic that speaks to your interest area and share insights with fellow attendees and an expert facilitator.

Strategic PV Operations Planning and Governance for Small & Emerging Companies
Explore how small pharma and biotech companies can build scalable, compliant, and resource-conscious PV operations. This roundtable will address practical approaches to governance, outsourcing, and technology that support drug safety monitoring throughout the product lifecycle, while considering the realities of limited resources and rapid growth. Discussion will center on key considerations for designing cost-effective PV systems that meet global expectations, how smaller organizations can maintain strong governance models, and the role of outsourcing and strategic partnerships in strengthening PV operations while preserving oversight and accountability.
Moderator: Nrupali Gandhi, Senior Director, Pharmacovigilance Operations, Summit Therapeutics

Paradigm Shift to Manage ICSRs – Future of Safety?
Let's discuss shifting the ICSR paradigm to better manage cases, signals, and ultimately patients. 1. What's working well with the current state? (things you don't want to lose) 2. What's broken with the current state? (barriers we must remove) 3. What absolutely must be true of an aspirational future state? (non-negotiables)
Moderator: Clint Craun, MA, Program Director, Transcelerate Biopharma

Early Recognition of Potential Adverse Drug Reactions through LLM Assessment of the Scientific Conference Literature: Are We Missing Potentially Important Evidence? Fewer than 40% of scientific conference abstracts reach peer-reviewed publication in journals and represent a potentially untapped resource of unreported safety data. This roundtable will examine how large language models can be applied to the conference literature to identify potential adverse drug reactions early in a drug’s product lifecycle and the results of a recent study conducted towards this end. Discussion will center on methodological approaches to text mining, the identification of safety signals potentially absent from prescribing information, PubMed, or FAERS, and the implications of incorporating conference data into pharmacovigilance workflows. Participants will consider how these data may enhance early signal detection and strengthen patient safety.
Moderator: Joseph Laudano, PharmD, Medical Director, IQVIA

Aggregate Safety Assessment Planning for Small to Mid-Size Companies This roundtable will address the topic of implementing a process for aggregate safety assessment planning (ASAP) at small to mid-size companies. While companies typically review serious adverse events in real time from ongoing studies, planning for aggregate safety reviews, both at an individual study level and across studies, is less often performed. The American Statistical Association Biopharma Safety Working Group has published a suggested approach which will be briefly described to open the discussion. Learnings from companies that have executed the ASAP process for a clinical development program will be considered. The intention is to have an interactive discussion about how an ASAP process can be implemented at small to mid-size companies with participants contributing their own experiences, challenges and questions.
Moderators: Barbara Hendrickson, MD, Clinical Associate, Pediatric Infectious Diseases, University of Chicago and Famina Hemani, Vice President, Head of Pharmacovigilance, Tourmaline Bio