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Networking Luncheon and Roundtable Discussions
Session Chair(s)
Kal Elhoregy, RPh
Senior Director, Global Risk Management & Pharmacovigilance Compliance
Amneal Pharmaceuticals, United States
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
More to be added soon.
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