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How MI, PV & Regulatory Collaborate on Signals, Labeling, Crisis Response and AI

 
  June 15, 2026  
     
 


Xtalks — The Life Science Community™, Online webinar
2026-07-22


Medical Information (MI), Pharmacovigilance (PV) and Regulatory Affairs (RA) each play distinct but deeply interconnected roles in ensuring that therapeutics are safe, accurately labeled and compliantly communicated to healthcare professionals and patients. Yet in practice, the boundaries between these functions are rarely clean; a safety signal surfaced through an MI inquiry can trigger a PV investigation, which in turn may prompt a label update, a Risk Management Plan revision and coordinated external communications. When these handoffs work well, they are nearly invisible. When they break down, the consequences can be significant.

This webinar brings together experienced cross-functional practitioners to examine how MI, PV and RA collaborate across the full product lifecycle, from the moment an inquiry arrives to the resolution of a safety crisis. Panelists will walk through the critical touchpoints that define effective collaboration: how potential adverse events are identified and escalated from MI to PV; how RA maintains labeling consistency in response to evolving safety data; and how all three functions align on response development for complex or sensitive inquiries, including off-label use scenarios.

The session will also address the realities of cross-functional work, including common pitfalls in communication and decision-making, and what organizations can do to avoid them. Particular attention will be given to crisis and escalation management, exploring how teams can build the structures and relationships needed to respond swiftly and cohesively when urgent safety situations arise.

Looking ahead, the panel will explore how the roles of MI, PV and RA are evolving in an increasingly data-rich environment. This includes a candid discussion of the opportunities and risks associated with AI and automation: how these technologies can strengthen signal detection, streamline cross-functional workflows and improve consistency across labeling and communications, and what governance frameworks are needed to ensure they are deployed responsibly.

Attendees will leave with practical insights on building stronger cross-functional partnerships, navigating complex escalations and preparing their organizations for the next generation of MI–PV–RA collaboration.

Register for this webinar to learn how MI, PV and RA can improve safety signal escalation, labeling alignment and crisis response across the product lifecycle.

 
 
Organized by: Xtalks — The Life Science Community™
Invited Speakers:

(Moderator) Alessandra Grossi, Medical Operations (MICC) Director, TransPerfect Life Sciences

Elke Blaetz, RPh, MS, Senior Director, Medical Information, uniQure

Ana Filipa Sousa, Associate Director, Head of Medical Affairs – UK & Ireland, Theramex

Dr. Kunvar Harsh Upveja, Global Oncology, Bone Health & Digital Lead, Biocon Biologics

 
Deadline for Abstracts: 2026-07-22
 
Registration:

https://xtalks.com/webinars/how-mi-pv-regulatory-collaborate-on-signals-labeling-crisis-response-and-ai/

E-mail: clientservices@xtalks.com
 
 
   
 
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