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

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.

Speakers

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

Alessandra Grossi is the Medical Operations Director at TransPerfect UK, with over 30 years of experience in the pharmaceutical industry. She has held leadership roles in Medical Information at local, regional and global levels, as well as positions in Medical Operations, Systems and Governance at Pfizer. Alessandra has led numerous system implementations, process harmonization initiatives and innovation programs. She is passionate about advancing medical information and communication and is committed to driving its evolution through technology adoption and innovative practices, enhancing efficiency, compliance and the overall impact of medical affairs functions globally.

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

Elke Blaetz brings 30 years of experience in industry-based medical information, spanning roles as both an individual contributor and leader across call center and medical teams, launch-ready and mature products and US, regional and global environments. Her expertise includes medical information training, call center outsourcing, technology enhancements, inspection readiness and cross-functional partnerships. She currently serves as the Senior Director of Medical Information at uniQure Inc., with prior leadership roles at Sarepta Therapeutics, Genentech and Roche. With a foundation in Clinical Pharmacy and a graduate degree in Health Communications, Elke is driven to deliver high-quality, evidence-based information that supports decision-making for healthcare professionals, patients and caregivers.

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

Ana Filipa Sousa is a multilingual Pharmacist and seasoned pharmaceutical professional with a Master’s Degree in Pharmaceutical Sciences and over 10 years of industry experience. She currently serves as the Associate Director and Head of Medical Affairs for the UK and Ireland at Theramex, bringing deep expertise across Medical Affairs, Medical Information and Sales. Throughout her career, Ana has held roles at leading global organizations, including Novartis and Eisai, building a strong track record across the UK, Ireland and broader EMEA markets. She has extensive working knowledge of the ABPI, IPHA and EFPIA Codes of Practice and has served as a Registered Medical Signatory.

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

Dr. Kunvar Harsh Upveja is a Global Medical Affairs leader specializing in oncology and biosimilars, currently with Biocon Biologics. With over a decade of experience across global markets, he drives clinical strategy, evidence generation, and KOL engagement to advance access to high-quality biologics worldwide.

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