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International Regulation and Harmonisation: A Global Approach
Session Chair(s)
Virginia Acha, PhD, MSc
AVP, Global Regulatory Policy
Merck Sharpe & Dohme LLC , 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)
Scene Setter: Combination Products – A Global Policy Landscape
Pieter Stolk
Exon Consultancy, Netherlands
Co-Founder & Partner
Navigating Global Regulatory Policy Differences for Combination Products – Pharma View
Shruthi Vidyasagar, MS
Novo Nordisk, India
Associate Director
Opportunities for Alignment – Regulator's Perspective
Alberto Ganan Jimenez, PhD
European Medicines Agency, Netherlands
Head of Committees and Quality Assurance
Panelist
Susanna Palkonen
EFA (European Federation of Allergy and Airways Diseases Patients' Associations), Belgium
Director
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