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INTERNATIONAL COLLABORATION IN THE REVIEW OF GENERIC DRUGS
Session Chair(s)
Beata Stepniewska, MPharm
Deputy Director , Head of Regulatory Affairs
Medicines for Europe, Belgium
With the globalisation trend, an increasing number of generic medicines manufacturers are keen to introduce their products at global scale. For health authorities, a need for fast supply of medicinal products from other markets may occur in case of unexpected shortages in their region. Single development program and more harmonised assessments of generic medicinal products between various markets in order to avoid unnecessary duplications of effort shall be discussed among the authorities and industry.
Speaker(s)
Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- EGA proposal
Beata Stepniewska, MPharm
Medicines for Europe, Belgium
Deputy Director , Head of Regulatory Affairs
Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- View of the CMDh
Peter Bachmann
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Deputy-Head, European Union and International Affairs
Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- Health Canada perspective
Mike Ward
World Health Organization (WHO), Switzerland
Coordinator, Regulatory Systems Strengthening, EMP
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