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Thursday, February 7 • 09:15 - 10:15
#S0905: Converging Global Life Science Regulation – Where Are We Heading in 2025?

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Component Type: Session

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?

Chair

Angelika Joos, MPharm

Speaker

The Future of Regulation: How to Thrive in the Converging Regulatory Environment
Sebastian Payne

EFPIA Perspective on Global Regulatory Convergence
Thomas Kühler, PhD, MSc

Regulators Setting Global Standards
Lenita Lindström-Gommers, LLM

WHO Supporting Regulators for Capacity Building and Global Collaboration
Mike Ward

IFPMA Views on Regulatory Systems Strengthening and Collaboration
Judith Catherine Macdonald


Speakers
avatar for Angelika Joos

Angelika Joos

Executive Director, Global Regulatory Policy, Merck Sharp & Dohme (Europe) Inc., Belgium
Angelika Joos is a trained pharmacist. She is responsible for Regulatory Policy issues within MSD's Global Regulatory Affairs and Clinical Safety department. This role includes identifying regulatory policy priorities that align with MSD’s business priorities, leading cross-functional... Read More →
avatar for Thomas Kühler

Thomas Kühler

Head GRSP EU/AMEE, Sanofi R&D, France
A PhD chemist by training with late Nobel Prize Laureate Donald J. Cram. In recognition of his contributions to the field of Medicinal Chemistry and longstanding experience in drug discovery he was appointed Associate Professor in Medicinal Chemistry at Uppsala University in Sweden... Read More →
avatar for Lenita Lindström-Gommers

Lenita Lindström-Gommers

ICH Assembly Chair and Senior Expert, European Commission, European Commission
Lenita Lindström-Gommers is a Senior Expert in the Directorate General for Health and Food Safety (DG SANTE) in the European Commission where she is responsible for international relations in the field of pharmaceuticals. Her main work relates to ICH where she was closely involved... Read More →
avatar for Judith Macdonald

Judith Macdonald

Head of Global Regulatory Policy & Intelligence, Pfizer
Judith is responsible for global regulatory policy development at Pfizer. She has more than 25 years’ experience in regulatory affairs, where she has been responsible for both small molecule and biological products across the entire development cycle. Judith joined Pfizer in 2007... Read More →
avatar for Sebastian Payne

Sebastian Payne

Associate Director, Deloitte
Sebastian is a Director at Deloitte specialising in Regulatory Advisory within Life Sciences and has over 18 years of experience in Life Sciences and Healthcare (LSHC) consultancy. He leads Deloitte CORE for LS (Centre of Regulatory Excellence for Life Sciences), a global initiative... Read More →
avatar for Mike Ward

Mike Ward

Coordinator, Regulatory Systems Strengthening, EMP, World Health Organization (WHO)
Mike Ward is Coordinator of the Regulatory System Strengthening Team, Department of Essential Medicines and Health Technologies, Health Systems and Innovation Cluster, WHO Headquarters; he joined WHO as the Coordinator, Prequalification Team, in this same Department. He previously... Read More →

Thursday February 7, 2019 09:15 - 10:15 CET
K1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  02 Evolution of Science and Policy, Session |   Hot Topics/Stand Alone, Session