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EMA guidelines

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[2018.08.14]Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure 


[2018.08.14]Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes 


[2018.08.13]Regulatory and procedural guideline: EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets 


[2018.07.30]Regulatory and procedural guideline: Procedure for orphan-medicinal-product designation: Guidance for sponsors submitting an application via the current existing submission process until 19 Sept 2018 


[2018.07.26]Regulatory and procedural guideline: How to register with EudraVigilance and EVDAS - Training module EV-M1 


[2018.07.26]Regulatory and procedural guideline: EudraVigilance registration manual 


[2018.07.26]Regulatory and procedural guideline: EudraVigilance release notes v.1.17 


[2018.07.26]Regulatory and procedural guideline: EudraVigilance - EVWEB user manual - Version 1.5 


[2018.07.25]Regulatory and procedural guideline: Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications - 2018-2019 


[2018.07.19]Regulatory and procedural guideline: Qualification opinion on dopamine transporter imaging as an enrichment biomarker for Parkinson’s disease clinical trials in patients with early Parkinsonian symptoms, adopted 



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