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Session 9: Regulatory Convergence
Session Chair(s)
Susanne Ausborn, PhD
Global Head International Regulatory Policy
Roche, Switzerland
Ursula Busse, PhD, MBA
Head of Regulatory Affairs
Tigen Pharma SA, Switzerland
Panel discussion with representatives from different national/regional/global regulatory bodies & industry associations engaged in supporting global regulatory convergence. Topic addressed will include: • Impact of data & digital on future collaboration/reliance • Regulations for innovative treatments: what is/will be the approach to translate science into regulatory science in a globalized context? • ‘Agile’ convergence - just another buzzword or reality? • Reliance & collaboration - Vision for 2030
Speaker(s)
Panel Discussion and Q&A, with the presence of:
Samvel Azatyan, MD, PhD
World Health Organization (WHO), Switzerland
Team Lead, Regulatory Convergence and Networks (RCN/REG)
Panel Discussion and Q&A, with the presence of:
Agnès Saint-Raymond, DrMed
European Medicines Agency, Netherlands
Head of Division International Affairs
Panel Discussion and Q&A, with the presence of:
Dmitriy Rozdestvensky, MD, PhD
Eurasian Economic Commission, Russian Federation
Head, Division for Coordination of Common Market for Drugs and Medical Devices F
Panel Discussion and Q&A, representing IFPMA:
Angelika Joos, MPharm
MSD, Belgium
Executive Director, Global Regulatory Policy
Panel Discussion and Q&A, representing FIFARMA:
Rebecca Lumsden, PhD
Sanofi, United Kingdom
Head of Regulatory Science & Policy EU/AMEE
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