EU 28: science, medicines, health - a regulatory system fit for the future
Date:
06/05/2013 to 07/05/2013
Location:
Dubrovnik, Croatia
The 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.
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Schedule - EU 28: science, medicines, health (PDF/111.8 KB)
First published: 21/05/2013
Last updated: 21/05/2013
EMA/74857/2013 -
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Agenda - Programme - EU 28: science, medicines, health (PDF/106.96 KB)
First published: 06/02/2013
Last updated: 21/05/2013 -
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Presentation - European Union legislative and policy developments in the medicinal products area (Stefano Soro) (PDF/131.89 KB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Croatian Agency for Medicinal Products and Medical Devices achievements during the instrument-for-pre-accession project (Viola Sarinic) (PDF/10.61 MB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Centralised-procedure extension to Croatia: Industry perspective (Mislav VuÄić) (PDF/473.14 KB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Croatia - Decision-making phasing-in (Tony Humphreys) (PDF/299.52 KB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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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 ... (PDF/443.28 KB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Active pharmaceutical ingredients – The new approach for third countries: Perspectives from an acceding country (Anita SuÄić) (PDF/360.03 KB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Pre-accession challenges: Croatian Agency for Medicinal Products and Medical Devices perspective (Maja Lovrek) (PDF/1.21 MB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Pharmacovigilance pre-accession challenges: Industry view (Tatjana Äuretek) (PDF/117.02 KB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Pre-accession regulatory challenges: Industry view (V. Kartelo) (PDF/103.29 KB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Regulatory pathways to new medicines (Tony Humphreys) (PDF/1.11 MB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Mutual-recognition-procedure and decentralised-procedure step-by-step instructions: How to apply and how the procedures are conducted (Peter Bachmann) (PDF/2.48 MB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Update on implementation of pharmacovigilance legislation (Franck Diafouka) (PDF/1.38 MB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Good-pharmacovigilance-practice modules I-IV: Pharmacovigilance quality assurance and control (Fergus Sweeney) (PDF/1.07 MB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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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 Pharmacovigila... (PDF/1.14 MB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Overview of good-pharmacovigilance-practice modules on adverse drug reactions, periodic safety update reports, signal management and additional monitoring (Mick Foy) (PDF/485.18 KB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Reporting of adverse drug reactions by patients – Croatian experience (Marina Giusti) (PDF/3.9 MB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Adverse-drug-reaction reporting – United Kingdom view (Mick Foy) (PDF/1023.5 KB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Patients reporting in Croatia - Patients' associations' experiences (Jurica Ester) (PDF/324.19 KB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Supervision of manufacturers: What is expected of national competent authorities? (Fergus Sweeney) (PDF/1.08 MB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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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) (PDF/696.95 KB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - What do manufacturers and importers have to do to prepare for European Union membership? (Vesna Koblar) (PDF/580.11 KB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Practical implementation of the Falsified-medicines Directive (Belà©n Romero) (PDF/1.44 MB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Going digital: General aspects (Klaus Menges, Olivier Simoen) (PDF/1.4 MB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Going digital: Current initiatives (Andrea Johnson, Olivier Simoen) (PDF/1.33 MB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Practical aspects of working electronically in the network: Croatian experience (Dubravka Sudić) (PDF/1.84 MB)
First published: 21/05/2013
Last updated: 21/05/2013 -
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Presentation - Practical aspects of working electronically in the network (Pieter Vankeerberghen) (PDF/110.67 KB)
First published: 21/05/2013
Last updated: 21/05/2013