EuroMeeting Globalisation Track: International collaboration in the review of Generic Drugs

Chair(s):Beata Stepniewska, MPharm
Director of Regulatory Affairs
European Generics Medicines Association EGA, Belgium

Description:
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.

Presentation(s) & Speaker(s):
Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- EGA proposal
Beata Stepniewska, MPharm
Director of Regulatory Affairs
European Generics Medicines Association EGA, Belgium

Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- View of the CMDh
Peter Bachmann, DrSc
Senior Expert; Chair, Coordination Group for Mutual Recognition and Decentralise
Federal Institute for Drugs and Medical Devices, Germany

Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- Health Canada perspective
Mike D. Ward
Manager, International Programs Division
Health Canada, Canada

for more Globalisation track sessions see Theme 13...