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ViewAttendees 7

Pharmaceuticals

New Pharmaceutical Legislation in Europe – From Legislation to Implementation

Wednesday, May 6, 2026
10:45 - 11:45 WEST
Location: Pavilion 5
Learning Level: Advanced
Description: This dynamic one-hour session offers regulatory professionals a rare opportunity to gain actionable insights directly from the key architects and stakeholders shaping the implementation of the New Pharmaceutical Legislation (NPL) in Europe. Attendees will hear firsthand perspectives from leaders across the regulatory ecosystem — including the EMA CHMP Chair, the CMDH Chair, the European Commission, industry, and EMA representatives — providing a uniquely comprehensive, 360-degree view of what NPL implementation means in practice.

Beyond understanding the legislative framework, participants will leave equipped to accelerate their organisation's Day 1 readiness. Whether you are responsible for regulatory strategy, submissions, lifecycle management, or policy engagement, the insights shared will help you anticipate regulatory changes, align internal processes, and engage more effectively with competent authorities during this pivotal transition period.
Key NPL changes will be introduced, followed by a structured panel discussion on key implementation considerations and next steps. A dedicated 10-minute Q&A session further ensures that participants can address their most pressing, context-specific questions directly with the experts — turning knowledge into tailored, applicable guidance.

Professionals attending this session will return to their organisations better positioned to lead NPL readiness efforts, contribute meaningfully to cross-functional implementation teams, and engage proactively with regulators. For those working at the intersection of regulatory science, policy, and operations, this session is an essential opportunity to stay ahead of one of the most significant shifts in European pharmaceutical regulation in decades.

Learning Objectives:

  • Provide multi-stakeholder perspectives on NPL implementation
  • Share practical tools and strategies for Day 1 readiness
  • Enable direct engagement between audience and key decision-makers
  • Foster understanding of cross-sector collaboration needs