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 them with final support on the legal aspects of the implementation of the acquis in their national system and its practical application. Registration open.

All documents

Name Language First published Last updated
Schedule - EU 28: science, medicines, health (English only) 21/05/2013  
Programme - EU 28: science, medicines, health (English only) 06/02/2013 21/05/2013
Presentation - EU legislative and policy developments in the medicinal products area (Stefano Soro) (English only) 21/05/2013  
Presentation - HALMED achievements during IPA project (Viola Sarinic) (English only) 21/05/2013  
Presentation - CP 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 - API – 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 - API – The new approach for third countries: Perspectives from an acceding country (Anita Sučić) (English only) 21/05/2013  
Presentation - Pre-accession challenges: HALMED 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 - MRP and DCP 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 Vigilance Practice Modules I-IV Pharmacovigilance quality assurance and control (Fergus Sweeney) (English only) 21/05/2013  
Presentation - Overview of GVP modules V (risk management systems), VIII (post-authorisation safety studies) and ENCePP (Thomas Goedecke) (English only) 21/05/2013  
Presentation - Overview of GVP Modules on ADR, PSURs, 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 - Patient ADR Reporting – UK view (Mick Foy) (English only) 21/05/2013  
Presentation - Patients reporting in Croatia - Patients association’s 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 HALMED and GMP 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 EU membership? - Pharmaceutical regulatory affairs consulting and education (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: Federal agency for medicines and health products (Pieter Vankeerberghen) (English only) 21/05/2013  

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