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Xtalks, Online
2025-11-11
In this live panel discussion, five IQVIA experts will examine the most critical safety and regulatory compliance shifts for 2026. Attendees will gain insights into AI’s real impact on regulatory operations and pharmacovigilance, the evolving stewardship role of medical information (MI) and how target product profiles (TPPs) can drive faster, smarter development decisions.
Attendees will leave with clear, actionable steps that can be applied immediately, including how to operationalize human-in-the-loop AI without compromising compliance, what to document and validate under the latest FDA guidance, how Local Qualified Persons for Pharmacovigilance (LQPPVs) should oversee vendor algorithms, the transparency standards MI teams must adopt and how TPPs can help pivot confidently amid uncertainty.
As regulatory frameworks continue to evolve, the conversation has shifted from “if” to “how” AI can augment the work of safety and regulatory professionals. For success in 2026, organizations should learn how to integrate AI transparently, maintain robust governance and unify decisions under shared strategic goals.
Register for this webinar to turn complexity into clarity and to learn how safety and regulatory compliance priorities are expected to shift through 2026.
Keywords: AI, CDMO/CMO, Clinical Operations, Clinical Research, Clinical Trials, CRO, Drug Development, Drug Safety, FDA, FDA Guidance, Medical Information, Pharmacovigilance, Regulatory, Regulatory Affairs, Regulatory Compliance, Toxicology/Safety
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Organized by:
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Xtalks |
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Invited Speakers:
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Michelle Gyzen, Senior Director, Strategic Regulatory Solutions; Head of Regulatory Services Innovation & Technology, IQVIA
Archana Hegde, Senior Director, PV Systems & Innovations, Lifecycle Safety, IQVIA
Ian Fisher, Head of Development Analytics, Regulatory Affairs and Drug Development Solutions, IQVIA
Louise Molloy, Associate Director Medical Information & Pharmacovigilance, IQVIA
Ana Pedro Jesuíno, Associate Director of Marketed Product Safety, IQVIA
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Deadline for Abstracts:
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2025-11-11
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Registration:
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Free Registration
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E-mail:
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tristan@xtalks.com
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