Links
Useful sites on services that Arriello cover:Registrations
Pharma-Registrations.com - Informative site giving you information about registering your drugs in the EU, USA, ASIA etc
Dossier-Filings.com - Like the above site, giving you information about how to register your pharmaceuticals
DCP-Filings.com - A site that specifcially looks at registering via DCP and the issues related to this
eCTD
eCTD-Conversions.com - A site that covers the issues relating to eCTD
Pharmacovigilance
EU-DrugSafety.com - A site dedicated to the isues regarding Pharmaciovigilance in the European Union (EU) form EUQPPV to PSURs and Literature Searching
Pharmacovigilance-Database.com - A site that addresses the issues of what to do when looking at implemeting a database as part of your Pharmacovigilance system
Medical Device Vigilance
Device-Vigilance.com - This site looks at the aspects to be comnsidered when wanting toimplement a Medical Device Vigilance system, similar to Pharmacovigilance for Pharmaceutical products
PIM
PIM-Migration.com - This site addresses the issues for Pharmaceutical companies who now have to address their global labelling, particularly for Centralised Procedures, now that PIm has been cancelled as a project by EMA (European Medicines Agency)
Readability Testing
Readability-Testing.com - English site that explains Readability Testing in EU in English
Testdelegibilidad.es - Spanish site that explains Readability Testing in Spain
Testdelizibilitate.ro - Romanian site that explains Readability Testing in Romania
Partners
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Farmavita - Excellent source of information for Regulatory Affairs. An excellent article on Readability Testing by Ryan Smith is available here.
Global Regulatory - An overview of Arriello and a source of partners for Regulatory projects.
Rozmaryna - An organisation in the Czech Republic set up to help underpriveliged children and sponsored by Arriello.
Pharma Tutor - A good source of information for Pharma events.
Pharma Labelling and Packaging
Competent Authorities
Austria - Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH http://ages.at/ | Bundesministerium für Gesundheit http://www.bmgfj.gv.at
Belgium - Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten - Agence Fédérale des Médicaments et des Produits de Santé
http://www.fagg-afmps.be
Bulgaria - Изпълнителна агенция по лекарствата http://www.bda.bg
Cyprus - Ministry of Health http://www.moh.gov.cy/moh/phs/phs.nsf/dmlindex_gr/dmlindex_gr?OpenDocument
Czech Republic - Státní ústav pro kontrolu léčiv www.sukl.cz
Denmark - Lægemiddelstyrelsen http://www.dkma.dk/1024/visUKLSForside.asp?artikelID=728
Estonia - Ravimiamet http://www.ravimiamet.ee
Finland - Lääkelaitos http://www.nam.fi
France - Agence Française de Sécurité Sanitaire des Produits de Santé http://www.afssaps.fr
Germany - Bundesinstitut für Arzneimittel und Medizinprodukte http://www.bfarm.de/cln_028/DE/Home/startseite__node.html__nnn=true
Greece - ΕΘΝΙΚΟΣ ΟΡΓΑΝΙΣΜΟΣ ΦΑΡΜΑΚΩΝ http://www.eof.gr/web/guest/home
Hungary - Országos Gyógyszerészeti Intézet www.ogyi.hu
Iceland - Lyfjastofnun http://www.imca.is
Ireland - Bord Leigheasra na hÉireann www.imb.ie
Italy - Agenzia Italiana del Farmaco http://www.aifa.gov.it/section8983.html
Latvia - Zāļu valsts aģentūra http://www.zva.gov.lv
Lithuania - Valstybinė vaistų kontrolės tarnyba prie Lietuvos Respublikos sveikatos http://www.vvkt.lt
Luxembourg - Ministère de la Santé http://www.ms.public.lu/fr
Malta - Awtorità dwar il-Mediċini http://www.gov.mt
Netherlands - College ter Beoordeling van Geneesmiddelen http://www.cbg-meb.nl/cbg/nl
Norway - Statens Legemiddelverk http://www.legemiddelverket.no
Poland - Agencja Oceny Technologii Medycznych http://www.aotm.gov.pl
| Narodowy Instytut Zdrowia Publicznego http://www.il.waw.pl
Portugal - INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. http://www.infarmed.pt/portal/page/portal/INFARMED
Romania - AGENŢIA NAŢIONALĂ A MEDICAMENTULUI http://www.anm.ro
Slovakia - Štátny ústav pre kontrolu liečiv http://www.sukl.sk/sk
Slovenia - Javna agencija Republike Slovenije za zdravila in medicinske pripomočke http://www.jazmp.si
Spain - Agencia Española de Medicamentos y Productos Sanitarios http://www.agemed.es
Sweden - Läkemedelsverket http://www.lakemedelsverket.se
Switzerland - Swiss Agency for Therapeutic Products http://www.swissmedic.ch/
United Kingdom - Medicines and Healthcare products Regulatory Agency http://www.mhra.gov.uk/index.htm
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