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EMA guidelines

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[2017.11.22]Regulatory and procedural guideline: EudraVigilance web application (EVWEB) v.1.0 - Release notes 


[2017.11.22]Regulatory and procedural guideline: EudraVigilance auditable requirement project: EudraVigilance training plan - Version 5, adopted 


[2017.11.22]Regulatory and procedural guideline: EudraVigilance XCOMP release - EudraVigilance web application (EVWEB) version 3.0 


[2017.11.22]Regulatory and procedural guideline: EudraVigilance - European database of suspected adverse reactions related to medicines: user manual for online access via the adrreports.eu portal - Version 2.0 


[2017.11.22]Regulatory and procedural guideline: EudraVigilance stakeholder change management plan 


[2017.11.22]Regulatory and procedural guideline: EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets 


[2017.11.22]Regulatory and procedural guideline: EudraVigilance - EVWEB user manual - Version 1.1 


[2017.11.22]Regulatory and procedural guideline: EudraVigilance user manual for marketing authorisation holders 


[2017.11.20]Regulatory and procedural guideline: Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions 


[2017.11.13]Regulatory and procedural guideline: Questions and answers on PSUSA: Guidance document for assessors 



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