Contáctenos
00 DÍAS
00 HRS
00 MIN
00 SEC
Acelerando la excelencia reglamentaria
Where domain expertise, digital innovation and data intelligence converge
La IA está llegando al ámbito reglamentario y el próximo reto es hacer que funcione en toda la empresa.
Únete a líderes sénior de las áreas de Asuntos Reglamentarios, I+D y Tecnología durante una jornada centrada en explorar cómo la Inteligencia Reglamentaria, los datos conectados, la IA y los agentes inteligentes están transformando las operaciones reglamentarias.
Reserva tu plaza
Su información solo se utilizará para gestionar su inscripción y las comunicaciones relacionadas con el evento.
Ponentes
Las personas que dan forma a la conversación
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
Director general
Freyr Solutions
Sudhir Kandarth
Director de ingresos
Freyr Solutions
Sathya K
Director de dominio
Freyr Solutions
Wajeed Abdul
Vicepresidente de estrategia y crecimiento
Freyr Solutions
Abhishek Rajan Desai
VP, Strategy & Partnerships
Freyr Solutions
Mohammad Sameer Siddiqui
Assistant Vice President
Freyr Solutions
Resumen del evento
Un día fuera de la oficina
debe valer la pena
Los equipos reglamentarios están pasando de las pruebas piloto de inteligencia artificial y las iniciativas tecnológicas desconectadas a la ejecución a escala empresarial.
Esto plantea preguntas más importantes.
Aceleración de la excelencia reglamentaria reúne a un grupo selecto de altos cargos para explorar esas cuestiones a través de conversaciones ejecutivas, perspectivas de clientes y demostraciones prácticas.
Llévate nuevas perspectivas, ejemplos prácticos e ideas para aplicar en tu organización.
01
¿Cómo debe aplicarse la inteligencia artificial?
Dónde aporta la inteligencia artificial un valor reglamentario medible hoy en día, y dónde sigue siendo una prueba piloto en busca de un problema.
02
¿Cómo es la inteligencia reglamentaria a escala empresarial?
Pasar del seguimiento y los informes a una inteligencia que abarque requisitos, presentaciones y decisiones a gran escala.
03
¿Dónde encajan los agentes inteligentes?
Qué flujos de trabajo reglamentarios pueden realizar los agentes de forma End-to-End y qué supervisión sigue requiriendo el trabajo.
04
¿Qué debe cambiar en materia de datos, tecnología, gobernanza y modelos operativos?
El trabajo estructural detrás de la tecnología: datos conectados, gobernanza clara y un modelo que los equipos realmente puedan gestionar.
Qué esperar
Un día diseñado para aprovechar tu tiempo al máximo
Únase a un grupo exclusivo de aproximadamente 100 altos cargos de los departamentos de Asuntos Reglamentarios, I+D, Tecnología, Datos e Inteligencia Artificial para explorar cómo podría ser la próxima fase del sector reglamentario.
01
Compara enfoques de transformación reglamentaria con tus colegas
02
Ve la IA, la Inteligencia Reglamentaria y los flujos de trabajo con agentes en acción
03
Conecta RIM, la Inteligencia Reglamentaria, los datos y la IA End-to-End
04
Explora tus prioridades con expertos en tecnología y asuntos reglamentarios
05
Intercambia puntos de vista con líderes que se enfrentan a retos similares
06
Líneas de acción prácticas para tu propia transformación
Agenda · 09:00 a. m. → 05:30 p. m. EST
Un programa de vía única diseñado para que cada debate complemente al 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
Preguntas frecuentes
¿Quién debe asistir?
+
Líderes sénior de Asuntos Regulatorios, Operaciones Reglamentarias, Inteligencia Reglamentaria, I+D, RIM, Tecnología, Datos e IA, y transformación reglamentaria.
¿Hay algún costo para asistir?
+
No. La asistencia es gratuita. El evento es exclusivo por invitación y las plazas son limitadas.
¿Cuánto dura el evento?
+
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.
¿Cuál es el formato?
+
Un programa ejecutivo de vía única que combina perspectivas de la industria, conversaciones con clientes, demostraciones prácticas, zonas de innovación y networking.
¿Dónde se celebra el evento?
+
The event will take place at Hyatt Regency Princeton, Princeton, New Jersey. Full arrival details will be shared with confirmed attendees. Get directions →
¿Puedo recomendar a otra persona?
+
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
¿Quién más debería estar presente?
¿Conoce a algún líder de asuntos regulatorios, I+D o tecnología cuya perspectiva aporte valor a la conversación? Recomiéndenoslo.
Todas las referencias están sujetas a la confirmación de asistencia.
La conversación comienza en
00
DÍAS
00
HORAS
00
MINUTOS
00
SEGUNDOS
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.
Reserva tu plaza
Su información solo se utilizará para gestionar su inscripción y las comunicaciones relacionadas con el evento.