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Acelerando a Exexcelência Regulatória
Where domain expertise, digital innovation and data intelligence converge
A IA está a entrar no setor regulatório e o próximo desafio é fazê-la funcionar em toda a organização.
Junte-se a líderes seniores das áreas de Regulamentação, I&D e Tecnologia durante um dia dedicado a explorar de que forma a Inteligência Regulatória, os dados conectados, a IA e os agentes inteligentes estão a transformar as operações regulatórias.
Reserve o seu lugar
As suas informações serão utilizadas apenas para gerir a sua inscrição e comunicações relacionadas com o evento.
Oradores
As pessoas que moldam a conversa
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
Presidente Executivo
Freyr Solutions
Sudhir Kandarth
Diretor de Receitas
Freyr Solutions
Sathya K
Diretor de Domínio
Freyr Solutions
Wajeed Abdul
Vice-presidente de Estratégia e Crescimento
Freyr Solutions
Abhishek Rajan Desai
VP, Strategy & Partnerships
Freyr Solutions
Mohammad Sameer Siddiqui
Assistant Vice President
Freyr Solutions
Visão geral do evento
Um dia fora do escritório
tem de valer a pena
As equipas regulatórias estão a passar de projetos piloto de IA e iniciativas tecnológicas isoladas para uma implementação à escala empresarial.
Isso levanta questões mais importantes.
Acelerando a Excelência Regulatória reúne um grupo seleto de líderes seniores para explorar essas questões através de conversas executivas, perspetivas de clientes e demonstrações práticas.
Leve consigo novas perspetivas, exemplos práticos e ideias para implementar na sua organização.
01
Como deve a IA ser aplicada?
Onde a IA cria valor regulatório mensurável hoje e onde ela ainda é apenas um projeto-piloto em busca de um problema.
02
Como é a Inteligência Regulatória corporativa?
Avançar da monitorização e dos relatórios para uma inteligência que abrange requisitos, submissões e decisões em grande escala.
03
Onde entram os agentes inteligentes?
Que fluxos de trabalho regulatórios os agentes podem realizar de ponta a ponta e qual a supervisão que o trabalho ainda requer.
04
O que precisa de mudar nos dados, na tecnologia, na governação e nos modelos operativos?
O trabalho estrutural por trás da tecnologia: dados conectados, governança clara e um modelo que as equipas conseguem efetivamente executar.
O que Esperar
Um dia concebido para valer o seu tempo
Junte-se a um grupo exclusivo de cerca de 100 líderes seniores de Regulatory, I&D, Tecnologia, Dados e IA para explorar como poderá ser a próxima fase da área Regulatória.
01
Compare abordagens de transformação regulatória com os seus pares
02
Veja a IA, a Inteligência Regulatória e os fluxos de trabalho baseados em agentes em ação
03
Conecte o RIM, a Inteligência Regulatória, os dados e a IA de End-to-End
04
Explore as suasprioridades com especialistas em Regulação e Tecnologia
05
Troque perspetivas com líderes que enfrentam desafios semelhantes
06
Leve ideias práticas para a sua própria transformação
Agenda · 09:00 → 17:30 EST
Um programa de via única concebido para que cada discussão complemente a anterior
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
Perguntas Frequentes
Quem deve participar?
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Líderes seniores nas áreas de Assuntos Regulamentares, Operações Regulamentares, Inteligência Regulamentar, I&D, RIM, Tecnologia, Dados e IA, e transformação regulamentar.
Há alguma taxa de inscrição?
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Não. A participação é gratuita. O evento é apenas por convite e os lugares são limitados.
Qual é a duração do 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 é o formato?
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Um programa executivo de via única que combina perspetivas da indústria, conversas com clientes, demonstrações práticas, zonas de inovação e networking.
Onde o evento será realizado?
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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 indicar outra pessoa?
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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.
Recursos
Take the next step
Quem mais deveria estar presente?
Conhece um líder da área regulamentar, de i&d ou de tecnologia cuja perspetiva enriqueceria a conversa? Indique-no-lo.
Todas as indicações estão sujeitas a confirmação de presença.
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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.
Reserve o seu lugar
As suas informações serão utilizadas apenas para gerir a sua inscrição e comunicações relacionadas com o evento.