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

• Date:
  Monday, 6 May 2013, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Schedule - EU 28: science, medicines, health

Reference Number: EMA/74857/2013

Agenda - Programme - EU 28: science, medicines, health

Presentation - European Union legislative and policy developments in the medicinal products area (Stefano Soro)

Presentation - Croatian Agency for Medicinal Products and Medical Devices achievements during the instrument-for-pre-accession project (Viola Sarinic)

Presentation - Centralised-procedure extension to Croatia: Industry perspective (Mislav VuÄić)

Presentation - Croatia - Decision-making phasing-in (Tony Humphreys)

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 ...

Presentation - Active pharmaceutical ingredients – The new approach for third countries: Perspectives from an acceding country (Anita SuÄić)

Presentation - Pre-accession challenges: Croatian Agency for Medicinal Products and Medical Devices perspective (Maja Lovrek)

Presentation - Pharmacovigilance pre-accession challenges: Industry view (Tatjana Äuretek)

Presentation - Pre-accession regulatory challenges: Industry view (V. Kartelo)

Presentation - Regulatory pathways to new medicines (Tony Humphreys)

Presentation - Mutual-recognition-procedure and decentralised-procedure step-by-step instructions: How to apply and how the procedures are conducted (Peter Bachmann)

Presentation - Update on implementation of pharmacovigilance legislation (Franck Diafouka)

Presentation - Good-pharmacovigilance-practice modules I-IV: Pharmacovigilance quality assurance and control (Fergus Sweeney)

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...

Presentation - Overview of good-pharmacovigilance-practice modules on adverse drug reactions, periodic safety update reports, signal management and additional monitoring (Mick Foy)

Presentation - Reporting of adverse drug reactions by patients – Croatian experience (Marina Giusti)

Presentation - Adverse-drug-reaction reporting – United Kingdom view (Mick Foy)

Presentation - Patients reporting in Croatia - Patients' associations' experiences (Jurica Ester)

Presentation - Supervision of manufacturers: What is expected of national competent authorities? (Fergus Sweeney)

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)

Presentation - What do manufacturers and importers have to do to prepare for European Union membership? (Vesna Koblar)

Presentation - Practical implementation of the Falsified-medicines Directive (Belà©n Romero)

Presentation - Going digital: General aspects (Klaus Menges, Olivier Simoen)

Presentation - Going digital: Current initiatives (Andrea Johnson, Olivier Simoen)

Presentation - Practical aspects of working electronically in the network: Croatian experience (Dubravka Sudić)

Presentation - Practical aspects of working electronically in the network (Pieter Vankeerberghen)