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Innovation in the Development and Approval of Generic Medicines
Session Chair(s)
Beata Stepniewska, MPharm
Deputy Director , Head of Regulatory 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)
Does the Current Regulatory Framework Facilitate Global Access and International Regulatory Strategy for Generic Medicines?
Michael L Banks, MSc
Teva Pharmaceuticals Europe, United Kingdom
Senior Vice President Regulatory Affairs
International Generic Drug Regulators Programme (IGDRP): The Path Towards Information and Work Sharing for Generic Medicines
Cordula Landgraf, RPh
Swissmedic, Switzerland
Head of Networking
How can ICMRA Support a better Convergence in Regulatory Framework?
Birte van Elk
Medicines Evaluation Board (MEB), Netherlands
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