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Quality Standards across the Globe – Evolution and Enforcement
Session Chair(s)
Susanne Keitel, DrSc, RPh
Director
European Directorate for the Quality of Medicines & Healthcare (EDQM), France
Ana-Maria Oltean, MSc
Quality Assurance and Regulatory Affairs Officer
Asphalion S.L., Spain
The interactive session will highlight the challenges globalisation poses for the availability of medicine and look into possible solutions international collaboration can offer for industry and regulators.
Learning Objective : You will be able to understand the challenges associated with globalisation of pharmaceutical operations. This presentation will provide an overview of how the generic medicines industry is promoting and communicating effective compliance with good practices throughout the global supply chain and where Industry and regulators can collaborate in order to tackle the effects of globalisation.
Speaker(s)
GCP and GMP Non-Compliance and What It Means for the Availability of Medicines in the EU
Anabela Marcal, PharmD
European Medicines Agency, Netherlands
EMA Liaison Official to the US FDA
Quality Standards across the Globe – Tackling the Impact of the Globalisation of Pharmaceutical Operations
Koen Nauwelaerts, PharmD, PhD, MBA
Bayer AG, Belgium
Regulatory Policy and Innovation Lead
Regulatory Submission and Inspections in Emerging Countries – How Does International Collaboration Affect Them?
Susanne Ausborn, PhD
Roche, Switzerland
Global Head International Regulatory Policy
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