EU 28: science, medicines, health - a regulatory system fit for the future

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TitleEU 28: science, medicines, health - a regulatory system fit for the future
Date06/05/2013 - 07/05/2013
LocationDubrovnik, Croatia
SummaryThe conference is supported by the European Commission and organised in collaboration with the Croatian Agency for Medicinal Products and Medical Devices (HALMED) in view of the imminent accession of Croatia to the European Union. The aim of the conference is to emphasise the work performed by the Croatian medicines authorities under the instrument-for-pre-accession assistance programme and to provide it with final support on the legal aspects of the implementation of the acquis in its national system and its practical application. Registration closed.

All documents

Name Language First published Last updated
Schedule - EU 28: science, medicines, health (English only) 2013-05-21  
Agenda - Programme - EU 28: science, medicines, health (English only) 2013-02-06 2013-05-21
Presentation - European Union legislative and policy developments in the medicinal products area (Stefano Soro) (English only) 2013-05-21  
Presentation - Croatian Agency for Medicinal Products and Medical Devices achievements during the instrument-for-pre-accession project (Viola Sarinic) (English only) 2013-05-21  
Presentation - Centralised-procedure extension to Croatia: Industry perspective (Mislav Vučić) (English only) 2013-05-21  
Presentation - Croatia - Decision-making phasing-in (Tony Humphreys) (English only) 2013-05-21  
Presentation - Active pharmaceutical ingredients – The new approach for third countries: What are the consequences? Should we expect shortage of medicinal products in the country? - Perspectives from an acceding country (Stefano Soro) (English only) 2013-05-21  
Presentation - Active pharmaceutical ingredients – The new approach for third countries: Perspectives from an acceding country (Anita Sučić) (English only) 2013-05-21  
Presentation - Pre-accession challenges: Croatian Agency for Medicinal Products and Medical Devices perspective (Maja Lovrek) (English only) 2013-05-21  
Presentation - Pharmacovigilance pre-accession challenges: Industry view (Tatjana Đuretek) (English only) 2013-05-21  
Presentation - Pre-accession regulatory challenges: Industry view (V. Kartelo) (English only) 2013-05-21  
Presentation - Regulatory pathways to new medicines (Tony Humphreys) (English only) 2013-05-21  
Presentation - Mutual-recognition-procedure and decentralised-procedure step-by-step instructions: How to apply and how the procedures are conducted (Peter Bachmann) (English only) 2013-05-21  
Presentation - Update on implementation of pharmacovigilance legislation (Franck Diafouka) (English only) 2013-05-21  
Presentation - Good-pharmacovigilance-practice modules I-IV: Pharmacovigilance quality assurance and control (Fergus Sweeney) (English only) 2013-05-21  
Presentation - Overview of good-pharmacovigilance-practice modules V (risk-management systems) and VIII (post-authorisation safety studies), and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (Thomas Goedecke) (English only) 2013-05-21  
Presentation - Overview of good-pharmacovigilance-practice modules on adverse drug reactions, periodic safety update reports, signal management and additional monitoring (Mick Foy) (English only) 2013-05-21  
Presentation - Reporting of adverse drug reactions by patients – Croatian experience (Marina Giusti) (English only) 2013-05-21  
Presentation - Adverse-drug-reaction reporting – United Kingdom view (Mick Foy) (English only) 2013-05-21  
Presentation - Patients reporting in Croatia - Patients' associations' experiences (Jurica Ester) (English only) 2013-05-21  
Presentation - Supervision of manufacturers: What is expected of national competent authorities? (Fergus Sweeney) (English only) 2013-05-21  
Presentation - Cooperation between Croatian Agency for Medicinal Products and Medical Devices and the good-manufacturing-practice inspectorate in supervision of manufacturers: Croatia’s experience so far (Ana Boban) (English only) 2013-05-21  
Presentation - What do manufacturers and importers have to do to prepare for European Union membership? (Vesna Koblar) (English only) 2013-05-21  
Presentation - Practical implementation of the Falsified-medicines Directive (Belén Romero) (English only) 2013-05-21  
Presentation - Going digital: General aspects (Klaus Menges, Olivier Simoen) (English only) 2013-05-21  
Presentation - Going digital: Current initiatives (Andrea Johnson, Olivier Simoen) (English only) 2013-05-21  
Presentation - Practical aspects of working electronically in the network: Croatian experience (Dubravka Sudić) (English only) 2013-05-21  
Presentation - Practical aspects of working electronically in the network (Pieter Vankeerberghen) (English only) 2013-05-21  

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