3D Tissue Models
5th Annual Registration of Generics Summit
Mövenpick Hotel Prague
Mozartova 1
Prague, Czech Republic
5th Annual Registration of Generics Summit
IIR Ltd 
Mozartova 1 
Czech Republic 
Movenpick Hotel Prague

Schedule of Presentations:

Tuesday, November 11, 2008
09:00:00 Registration and coffee
09:30:00 Opening remarks from the Chair
09:40:00 Agency expectations for the Decentralised Procedure Regulatory update: Gabriele Eibenstein
10:20:00 Examining the use of DCP and MRP procedures and their impact on generic drug submissions Industry case study Pálfiné Gróots Herta
11:00:00 Morning coffee
11:20:00 The regulator’s perspective on changes within the process of filing Variations Marlies Kubbinga,
12:00:00 Understanding the impact on the new filing Variations guideline on the generic industry: an industry perspective Radka Polakova
12:40:00 Lunch
13:50:00 Practical experience of successful eCTD submissions Industry case study: Murat Hamzakadi,
14:30:00 Submitting the eCTD from an agency view – what are the current guidelines and expectations? Klaus Menges,
15:10:00 Afternoon refreshments
15:30:00 Effective lifecycle management for generic applications Case study: Claire Chin
16:10:00 Latest industry update on the CMD(h) referral procedure Hernani Seri
16:50:00 Panel discussion:
17:20:00 Chair’s closing remarks
17:30:00 End of Day One
Wednesday, November 12, 2008
09:00:00 Conference Day Two: Registration and coffee
09:30:00 Opening remarks from the Chair
09:40:00 Patent issues relating to registration of generic pharmaceuticals Luke Kempton
10:20:00 Meeting the latest regulatory requirements for paediatric medicine Joachim Boos
11:00:00 Morning coffee
11:20:00 PIL User Testing Industry update: Michel Mikhail
12:00:00 Bioequivalence requirements for generics Ander’s Fuglsang
12:40:00 Lunch
13:50:00 Registration of biogenerics: Opportunities and challenges James Harris
14:30:00 Update for the generics industry Pharmacovigilance: Marina Belle
15:10:00 Afternoon coffee
15:30:00 Examining the latest changes in European policy Anti- counterfeiting: Howard Rosenberg,
16:10:00 Merger & Acquisition activity within the generics market Panel discussion:
16:50:00 Chair’s closing remarks
17:00:00 End of conference
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