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Adopting an AI-forward approach to the R&D IT ecosystem means moving beyond experimentation to embedding AI into core business processes across safety, regulatory, quality, and medical affairs.

Real-world impact depends on more than deploying models—it requires integration into workflows, data harmonization, and user trust. A platform-first approach, underpinned by strong data governance and cloud scalability, ensures AI becomes a true co-pilot across functions. As pharma companies evolve toward digital maturity, operationalizing AI across the R&D value chain will be a critical lever for speed, compliance, and innovation.

February 10–11, 2026

The Palace, Pl. de las Cortes 7, Madrid, Spain

Leaders and professionals across life sciences

Reasons to Attend

  • Learn from Global Peers

    Exchange ideas and gain practical insights from peers from across the globe who are leveraging AI-powered technology.

  • Engage with LifeSphere Experts

    Connect with leading experts and partners at the Breakthrough Innovation Center.

  • Experience AI in Action

    Get hands-on experience with the latest AI-forward technology available today.

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Register Here

Don’t miss the industry’s leading AI event.

Featured Speakers

Denny Lorenz

Managing Director and Principal Consultant

Lorenz Bratti GmbH

Myra Abousabe

Exec. Dir, Strategy & Application Operations, Drug Development IT

Bristol Myers Squibb

Bina Patel

AVP, Pharmacovigilance Operations

Amgen

Raj Ratwani

VP of Scientific Affairs & Director, National Center for Human Factors

MedStar Health Research Institute

Sam Wallis

Head of Case Management, Patient Safety

Bristol Myers Squibb

Michael Murphy

Senior Vice President, Head of Regulatory Affairs and PV Operations

Astellas

Julie Thomas

Vice President, Global Medical Safety Operations

Johnson & Johnson

Felix Arellano

Global Head of Pharmacovigilance

Roche

Marta Higuera

AI Labs Director

Insud Pharma

Michael Sonntag

Director Global Regulatory Affairs & Pharmacovigilance

Worwag

Fabrice Besle

Head of Technology and Digital, Patient Safety

Ipsen

Mariette Boerstoel

Senior Vice President, Worldwide Patient Safety Officer

Bristol Myers Squibb

Claudia Schaffer

Head of ICSR Management

Merck KGaA

Frits Stulp

Partner – Life Sciences

Implement Consulting Group

Griselda Saldana

Senior Director, Global Safety

Amgen

Ellen Mishalov

Executive Director, Head of PV Transformation and Technology

Astellas

Attila Olah

Head of Global Patient Safety

Gedeon Richter

Claudia Lehmann

Head of Global Pharmacovigilance Operations

Boehringer Ingelheim

Andrea Rogers

Executive Director, R&D Informatics

Amgen

Preeya Beczek

Regulatory Affairs and Compliance – Director and Co-founder

BECZEK.COM

Steve Gens

Managing Partner

Gens & Associates

Yvonne Schäfer

Head of PSPV Systems Business Solutions

Boehringer Ingelheim

Amrit Gill

Global Head of Safety (PV)

Opella

Remco Munnik

Owner & Founder

Arcana

Sandeepa Raina

Senior Director, IT Business Partner, Worldwide Patient Safety – R&D Informatics

Bristol Myers Squibb

Spencer Michelson

Director

Nordic Capital

Aman Wasan

Chief Executive Officer

ArisGlobal

Lucinda Smith

Chief Safety Product Officer

ArisGlobal

Jason Bryant

General Manager, NavaX

ArisGlobal

More to be announced

Hear from Our Attendees

“One of the best conferences with meaningful information“

Worldwide Patient Safety Officer

“The overall energy was very powerful—the perfect opportunity to meet our vendors in person, connect beyond the screens, collaborate with peers, learn from leading pharma companies, and gain new ideas.”

Global Head of Regulatory Operations

“Great opportunity to learn, network with a variety of people and have good ideas and experiences under one roof. The opportunity to listen, ask questions and seek advice from people was really great.”

Head Global PV Operations

Discussions you won’t want to miss

  • Real-world GenAI and Agentic AI use cases driving operational efficiency, accelerating development timelines, improving decision-making, and strengthening compliance.
  • Making the business investment case for AI; bridging the gap between business and IT
  • From promise to pay off – the value of technology, data, and insights
  • Organizational readiness, change management, MLOps, and internal alignment required for adopting new technologies

  • Upcoming advanced automation, GenAI, and Agentic AI features as part of the LifeSphere Unify platform

  • Discover how PV and Regulatory teams are using reporting frameworks to capture and share AI-driven efficiency and cost gains – driving adoption and learning across the organization

Travel & Info

VENUE

We are thrilled to bring Breakthrough 2026 to
Madrid, Spain on February 10-11.

The Palace
Pl. de las Cortes,
7, Centro, 28014 Madrid, Spain

Enjoy a special group rate at The Palace, complete with breakfast, flexible booking, and loyalty point eligibility.

Reserve your stay here.

Additional nearby hotels:

*Please note: Whilst ArisGlobal recommends these hotels no room block has been secured

About

Breakthrough 2026 is ArisGlobal’s annual flagship event, bringing together life sciences leaders, pharmaceutical innovators, and regulatory authorities.

Join us for keynotes, panels, and networking sessions that explore how PV and Regulatory teams are making AI a core part of daily operations.

Experience live demos of LifeSphere and LifeSphere NavaX in the Innovation Center, and connect with ArisGlobal’s partners through our open ecosystem.

ArisGlobal reserves the right to deny registrants upon review.