Biotech China 2014
16th Annual Conference Regulatory Affairs in Central and Eastern Europe
Radisson SAS Beke Hotel
Terez Korut, 43, H-1067
Budapest, Hungary
http://www.informa-ls.com/ceeregulatory
16th Annual Conference Regulatory Affairs in Central and Eastern Europe
Informa Life Sciences
Radisson SAS Beke Hotel

Schedule of Presentations:

Tuesday, April 21, 2009
08:25:00 Check-In
08:30:00 Registration
09:00:00 Opening remarks by the Chairperson
09:10:00 Managing submissions through the Decentralised Procedure (DCP) Herta Pálfi Goóts
09:50:00 Practical experience with the Mutual Recognition Procedure (MRP) Maria Kenez
10:30:00 Morning coffee and networking Taosheng Chen, Michael McMillian, Jinghai Xu, Sashi Nadanaciva
11:00:00 Experience from MRP, CMD and CHMP referral - Novo Nordisk case study on a solid dosage product approved in 2008 Astrid Spillum
11:40:00 Gaining market access in Lithuania Rimas Jankunas
12:20:00 Spotlight session
12:50:00 Lunch
14:00:00 Working with national Polish regulations Ewa Lepczy´nska
14:40:00 Gaining access to the Czech Republic market Stanislav Mat˘ejek
15:20:00 Pushing the borders: working with Serbia, Montenegro, Bosnia and Herzegovina Danka Elez
16:00:00 Afternoon refreshments and networking
16:30:00 Serbia and the regulatory procedures A. Stojanovic
17:10:00 Regulatory challenges in Croatia Lana Ili´c Prelogovi´c
17:15:00 Summary
17:50:00 Closing remarks by the Chairperson and end of Day 1
17:55:00 Anouncements
18:00:00 Details Of The Next Conference
Wednesday, April 22, 2009
08:55:00 Check-In
09:00:00 Opening remarks by the Chairperson
09:10:00 Pharmaceutical pricing and reimbursement in CEE Sabine Vogler
09:50:00 Regulatory updates on packaging and labelling and PIM for CEE Klaus Menges
10:30:00 Morning coffee
11:00:00 Conducting readability testing in CEE Borisslav Borissov
11:40:00 Budget management for your Regulatory department Ludevit Martinec
12:20:00 Practical session on budget management
13:00:00 Lunch
14:10:00 Understanding the impact of the new EMEA Variations guideline Andrey Mladenov
14:50:00 Pharmacovigilance: Maintaining post approval commitments Gabor Koncsik
15:30:00 Afternoon refreshments
16:00:00 Counterfeit medicines Jim Thomson
16:40:00 Building a successful dossier for submission Luka Luk˘si´c
17:20:00 Closing remarks by the Chairperson and end of conference
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