Plenary Session - Disruptive Innovation: Redefining Regulatory Roles

Friday, May 16, 2025

08:30 - 10:00 CEST

Location: Gold Hall (level 0)

Moderator(s)

Gert W. Bos, PhD FRAPS

Consultancy
QServe Group
Arnhem, Gelderland, Netherlands
Jennifer Neff, PhD

Principal Consultant & Head of Medical Devices
Entourage GmbH
Berlin, Germany

Keynote Panelist(s)

Rebecca Lumsden, PhD (she/her/hers)

Head of Regulatory Science & Policy EU/AMEE
Sanofi
Reading, England, United Kingdom

Slides

Panelist(s)

Stefanie Fasshauer, MBA

Director (Pharma/Biotech)
Cisema
Udo Heintz, PhD (he/him/his)

Head of Quality Assurance and Regulatory Affairs
Ada Health GmbH, Germany
Muriel Pasté, PhD (she/her/hers)

Head of EU Regulatory Affairs
UCB
Brussels, Belgium
Michal Wosiak, MPharm (he/him/his)

Junior Regulatory Affairs Specialist
Pharmaceutical Company

Description: As disruptive technologies reshape industries, this plenary session will examine how regulatory roles must evolve to stay relevant. Experts will present case studies of innovative companies successfully navigating regulatory landscapes, illustrating how regulators can adapt their strategies to foster innovation without compromising safety. Participants will leave with a roadmap for redefining their roles in an era of disruption.