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Accelerare l'eccellenza regolatoria
Where domain expertise, digital innovation and data intelligence converge
L'intelligenza artificiale sta entrando nel settore normativo e la prossima sfida è farla funzionare in tutta l'azienda.
Unisciti ai dirigenti dei reparti Normativo, R&D e Tecnologia per una giornata focalizzata su come l'intelligence normativa, i dati connessi, l'intelligenza artificiale e gli agenti intelligenti stanno trasformando le attività normative.
Prenota il tuo posto
Le tue informazioni saranno utilizzate esclusivamente per gestire la tua registrazione e le comunicazioni relative all'evento.
Relatori
Le persone che guidano la conversazione
Chris Lee
VP, Regulatory Affairs Innovation and Strategic Operations
Gilead Sciences
Jack Cohen
Executive Director, Global Head, Regulatory Affairs Business Operations
Takeda
Lauren Orme
Senior Director, Regulatory Affairs
West Pharmaceutical Services, Inc.
Boris Reznichenko
Senior Director, Head of Global Regulatory Operations and Clinical Transparency
Otsuka Pharmaceutical
Andres Del Rio
Global Director of Regulatory Affairs & Health Science
LIPTON Teas and Infusions
Ryan McNeely
Senior Director - Regulatory Affairs Human Capital
Gilead Sciences
Andrew Robertson
SVP and Head of Regulatory Affairs and Quality
Denali Therapeutics
Suren Dheenadayalan
Chief Executive Officer
Freyr Solutions
Sudhir Kandarth
Chief Revenue Officer
Freyr Solutions
Sathya K
Chief Domain Officer
Freyr Solutions
Wajeed Abdul
Vice Presidente, Strategia e Crescita
Freyr Solutions
Abhishek Rajan Desai
VP, Strategy & Partnerships
Freyr Solutions
Mohammad Sameer Siddiqui
Assistant Vice President
Freyr Solutions
Panoramica dell'evento
Una giornata fuori dall'ufficio
deve valerne la pena
I team regolatori stanno passando da progetti pilota di intelligenza artificiale e iniziative tecnologiche isolate a un'applicazione su scala aziendale.
Ciò solleva interrogativi più importanti.
Accelerating Regulatory Excellence riunisce un gruppo selezionato di dirigenti per approfondire questi temi attraverso confronti diretti, punti di vista dei clienti e dimostrazioni pratiche.
Porta a casa nuove prospettive, esempi pratici e idee da applicare nella tua organizzazione.
01
Come dovrebbe essere applicata l'intelligenza artificiale?
Dove l'intelligenza artificiale crea un valore regolatorio misurabile oggi e dove invece è ancora un progetto in cerca di uno scopo.
02
Cos'è la Regulatory Intelligence a livello aziendale?
Il passaggio dal monitoraggio e dai report a una conoscenza approfondita che incide su requisiti, sottomissioni e decisioni su larga scala.
03
Qual è il ruolo degli agenti intelligenti?
Quali flussi di lavoro normativi gli agenti possono gestire end-to-end e quale supervisione richiedono ancora.
04
Cosa deve cambiare in termini di dati, tecnologia, governance e modelli operativi?
Il lavoro strutturale dietro la tecnologia: dati connessi, governance chiara e un modello che i team possano effettivamente gestire.
Cosa aspettarsi
Una giornata pensata per valere il tuo tempo
Unisciti a un gruppo di circa 100 leader senior dei reparti Regolatorio, R&D, Tecnologia, Dati e IA, accessibile solo su invito, per scoprire quale potrebbe essere il futuro del settore regolatorio.
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Confronta gli approcci di trasformazione normativa con i tuoi colleghi
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Scopri l'intelligenza artificiale, l'intelligence normativa e i flussi di lavoro basati su agenti in azione
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Collega RIM, l'intelligence normativa, i dati e l'intelligenza artificiale end-to-end
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Esplora le tue priorità con esperti di normative e tecnologia
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Scambia opinioni con leader che affrontano sfide simili
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Porta a casa idee pratiche per la tua trasformazione
Agenda · 09:00 → 17:30 EST
Un programma a binario unico pensato affinché ogni discussione si basi su quella precedente
09:00 – 09:15 AM
Welcome note – Setting the stage for the future of regulatory excellence Regulatory organizations are facing unprecedented pressure to accelerate innovation, navigate increasing complexity, and extract greater value from data. This opening address will explore why incremental improvements are no longer enough and why regulatory transformation has become a strategic business imperative.
Sudhir Kandarth Chief Revenue Officer
Freyr Solutions
Freyr Solutions
09:15 – 09:45 AM
Keynote - The regulatory imperative: R&D, Regulatory & AI As AI becomes embedded across the life sciences value chain, regulatory teams have an opportunity to move from operational support functions to strategic enablers of innovation. This keynote will explore how regulatory, R&D, and digital functions can work together to accelerate development, improve decision-making, and deliver better business outcomes.
Chris Lee VP, Regulatory Affairs Innovation and Strategic Operations
Gilead Sciences
Gilead Sciences
09:45 – 10:45 AM
Presentation - The future of regulatory excellence What does the next-generation regulatory enterprise look like? This session will present a vision for connecting domain expertise, digital capabilities, and enterprise data into a unified operating model. Through real-world use cases, platform demonstrations, and customer perspectives, attendees will see how AI, intelligence, and connected workflows can help organizations improve productivity, compliance, and business agility.
Suren Dheenadayalan Chief Executive Officer
Freyr Solutions
Freyr Solutions
10:45 – 11:00 AM
Conversations over coffee Networking and innovation zone
11:00 AM – 12:00 PM
Demo: Delivering enterprise regulatory intelligence at scale Regulatory organizations generate enormous amounts of data, but turning that data into actionable intelligence remains a significant challenge. This session will showcase how modern intelligence platforms, analytics, and AI agents can transform fragmented information into meaningful business insights. Through an end-to-end scenario, attendees will see how organizations can move from reporting historical activity to driving proactive decisions and strategic actions.
Wajeed Abdul Vice President, Strategy & Growth
Freyr Solutions
Freyr Solutions
12:00 – 01:00 PM
Panel Discussion: Driving regulatory excellence Regulatory leaders from across industries will discuss the challenges shaping today's operating environments and the lessons they are carrying into the future. Topics will include workforce evolution, operating models, technology adoption, organizational readiness, and leadership priorities. The session will provide insights into what is working today, what organizations continue to struggle with, and how leading companies are preparing for the future.
- Boris Reznichenko Senior Director, Head of Global Regulatory Operations and Clinical Transparency
Otsuka Pharmaceutical - Ryan McNeely Senior Director - Regulatory Affairs Human Capital
Gilead Sciences - Lauren Orme Senior Director, Regulatory Affairs
West Pharmaceutical Services, Inc. - Andres Del Rio Global Director of Regulatory Affairs & Health Science
LIPTON Teas and Infusions - Moderator: Sudhir Kandarth Chief Revenue Officer
Freyr Solutions
01:00 – 02:00 PM
Lunch & networking Interactive experience zones showcasing Freyr offerings and capabilities
02:00 – 02:30 PM
Fireside Chat - Rethinking Regulatory Information Management This session will examine how leading organizations are rethinking the role of RIM to support greater agility, intelligence, and cross-functional collaboration. The discussion will cover emerging business needs, adoption challenges, and the capabilities required to unlock greater value from regulatory information investments.
- Coming Soon Expert from leading biopharma organization
- Moderator: Sameer Siddiqui AVP, FDL FreyaFusion
Freyr Solutions
02:30 – 03:00 PM
Demo - Agentifying post-approval change management Post-Approval Change Management remains one of the most complex and resource-intensive regulatory processes. This session will demonstrate how agentic AI can automate planning, impact assessments, workflow orchestration, and execution across the PACS lifecycle. Attendees will experience an end-to-end demonstration that illustrates how intelligent agents can augment regulatory teams, reduce manual effort, and accelerate decision-making.
Harshith Subramanian Senior Manager
Freyr Solutions
Freyr Solutions
03:00 – 03:30 PM
Conversations over coffee Networking and innovation zone
03:30 – 04:15 PM
Panel Discussion - Reimagining the regulatory operating model The future of regulatory organizations will not simply be defined by technology, but by how people, processes, data, and AI work together. Industry leaders will discuss how operating models must evolve to support greater speed, scalability, intelligence, and business alignment. Topics will include organizational design, talent transformation, governance, data strategy, and the role of AI in shaping the regulatory function of the future.
- Jack Cohen Executive Director and Global Head of Regulatory Business Operations
Takeda - Andrew Robertson SVP and Head of Regulatory Affairs and Quality
Denali Therapeutics - Sathya K Chief Domain Officer
Freyr Solutions - Moderator: Abhishek Rajan Desai VP, Strategy & Partnerships
Freyr Solutions
04:15 – 04:30 PM
Wrap-up & closing remarks The next chapter begins here. The day concludes with a reflection on the themes, insights, and calls to action that emerged throughout the summit. Attendees will leave with a clearer understanding of where regulatory transformation is headed and how they can begin applying these ideas within their own organizations. The session will reinforce the key takeaways from FreyrOne and outline the journey ahead.
Sudhir Kandarth Chief Revenue Officer
Freyr Solutions
Freyr Solutions
Domande frequenti
Chi dovrebbe partecipare?
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Leader senior nei settori Affari Regolatori, Operazioni Regolatorie, Regulatory Intelligence, R&D, RIM, Tecnologia, Data & AI e trasformazione regolatoria.
È previsto un costo per la partecipazione?
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No, la partecipazione è gratuita. L'evento è su invito e i posti sono limitati.
Quanto dura l'evento?
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The core program runs from 09:00 AM – 04:30 PM ET, followed by networking and cocktails from 04:30 PM – 05:30 PM ET.
Qual è il formato?
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Un programma esecutivo a traccia unica che unisce prospettive del settore, confronti con i clienti, dimostrazioni pratiche, aree di innovazione e networking.
Dove si tiene l'evento?
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The event will take place at Hyatt Regency Princeton, Princeton, New Jersey. Full arrival details will be shared with confirmed attendees. Get directions →
Posso segnalare un'altra persona?
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Yes. Use Refer a Peer to nominate someone whose perspective would add value to the conversation. Attendance will be subject to confirmation.
Risorse
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Chi altro dovrebbe essere presente?
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Tutti gli inviti sono soggetti a conferma di partecipazione.
La conversazione inizia tra
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Your next Regulatory advantage starts with one conversation.
Invite-only and complimentary to attend. To keep the discussions focused and peer-led, attendance is limited.
Submit your details and we'll confirm your place by email.
Prenota il tuo posto
Le tue informazioni saranno utilizzate esclusivamente per gestire la tua registrazione e le comunicazioni relative all'evento.