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Innovation in the Development and Approval of Generic Medicines
Session Chair(s)
Beata Stepniewska, MPharm
Executive Director, Regulatory & Scientific Affairs, Medicines for Europe, Belgium
As generic medicines companies are becoming more global and sophisticated in their R&D, they are seeking a more globally integrated approach to scientific and clinical data generation to avoid duplication. The objective of the session is to discuss the possibility of a single development programme to support the registration of a generic medicine in multiple world regions.
Learning Objective : Understand the main objectives and activities of the IGDRP Discuss principles and potential models for information and work sharing Discuss potential implications for the approval of generic medicines within your company
Speaker(s)
Michael L Banks, MSc
Senior Vice President Regulatory Affairs, Teva Pharmaceuticals Europe, United Kingdom
Does the Current Regulatory Framework Facilitate Global Access and International Regulatory Strategy for Generic Medicines?
Cordula Landgraf, RPh
Head of Networking, Swissmedic, Switzerland
International Generic Drug Regulators Programme (IGDRP): The Path Towards Information and Work Sharing for Generic Medicines
Birte van Elk
, Medicines Evaluation Board (MEB), Netherlands
How can ICMRA Support a better Convergence in Regulatory Framework?
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