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

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