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Converging Global Life Science Regulation – Where Are We Heading in 2025?
Session Chair(s)
Angelika Joos, MPharm
Executive Director, Global Regulatory Policy
MSD, Belgium
The session will set out a vision for a globalised regulatory framework and provide opportunity for regulators and industry to discuss the current and future state of convergence for the benefit of patients’ access. Faster adoption of new technologies, common global standards & requirements, increased collaboration among regulators and rapid adoption of new technologies can accelerate the regulatory licensing process, simplify compliance and facilitate the regulatory surveillance of marketed medicinal products. What can we do to make this happen?
Learning Objective : Against the backdrop of the new Global Benchmarking Tool and other regulatory system strengthening initiatives how can we effectively promote ‘better’ regulation through reliance, work-sharing and recognition procedures instead of just encouraging ‘more’ regulation? Learn about examples of best practices from the perspective of different stakeholders
Speaker(s)
The Future of Regulation: How to Thrive in the Converging Regulatory Environment
Sebastian Payne
Deloitte, Netherlands
Partner LSHC
EFPIA Perspective on Global Regulatory Convergence
Thomas Kühler, PhD, MSc
Sanofi R&D, France
Head GRSP EU/AMEE
Regulators Setting Global Standards
Lenita Lindström, LLM
European Commission, Belgium
ICH Assembly Chair and Senior Expert, European Commission
WHO Supporting Regulators for Capacity Building and Global Collaboration
Mike Ward
World Health Organization (WHO), Switzerland
Coordinator, Regulatory Systems Strengthening, EMP
IFPMA Views on Regulatory Systems Strengthening and Collaboration
Judith Catherine Macdonald
Pfizer, United Kingdom
Senior Director, Global Policy Development
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