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International Regulation and Harmonisation: A Global Approach
Session Chair(s)
Virginia Acha, PHD, MSC
Global Lead, Global Regulatory Policy, Merck & Co., Inc., United States
Despite over five decades in development and use, regulation for drug-device combination faces challenges in international alignment and keeping pace with technology. In this session, we will explore the current global landscape and prospects for alignment.
Learning Objective : - Outline of Reg landscape for combination products in international markets - Assessment of available pathways in various markets - What does it take for a global submission? - Case study- global submission of a combination product
Speaker(s)
Pieter Stolk
Co-Founder & Partner, Exon Consultancy, Netherlands
Scene Setter: Combination Products – A Global Policy Landscape
Shruthi Vidyasagar, MS
Associate Director, Novo Nordisk, India
Navigating Global Regulatory Policy Differences for Combination Products – Pharma View
Alberto Ganan Jimenez, PHD
Head of Committees and Quality Assurance, European Medicines Agency, Netherlands
Opportunities for Alignment – Regulator's Perspective
Susanna Palkonen
Director, EFA (European Federation of Allergy and Airways Diseases Patients' Associations), Belgium
Panelist
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