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News dal mondo

17

Mar

HERA signs agreement with ECDC and with EMA to strengthen cooperation on health emergency preparedness and response

EMA has agreed working arrangements with the Health Emergency Preparedness and Response Authority (HERA) to strengthen its cooperation with the recently established body. The arrangements cover the exchange of information and access to IT systems and tools in areas of shared interest.
 
The non-binding agreement states that EMA and HERA will organize joint meetings, provide access to information systems and other IT tools, and exchange scientific expertise related to cross-border threats.
 
HERA and EMA have identified five specific areas of cooperation: assessment of cross-border threats to medical countermeasures; identification of medical countermeasures; identification of vulnerabilities in the supply of medical countermeasures; coordination on medical countermeasures in emergencies; and reinforcing the global health emergency preparedness and response architecture.
 
The collaborators have provided information on how they will work together in each area, explaining, for example, that EMA will help HERA identify risks of shortages for specific medical countermeasures and that HERA aims to ensure “the interoperability of its Intelligence Gathering Platform with existing or future EMA IT systems.”... [EMA]

24

Mar

AIFA - Criteri per l’attribuzione di distinti numeri di AIC in fase di domanda di nuova AIC/estensione o a seguito di variazione

Si informano i Titolari AIC che, al fine di rendere trasparenti i criteri adottati dall’Agenzia...

23

Mar

IMS Micronizzazioni: “Making Pharmaceuticals per parlare delle ultime novità in campo di micronizzazione”

Il settore farmaceutico si riunisce a Milano per fare il punto sulle ultime novità e sulle prospettive...

23

Mar

EDQM - What is the CEP 2.0 and what will change?

The CEP 2.0 (new name of the CEP of the future) is a “new-look” CEP that will better meet...

17

Mar

EMA - EVALUATION GUIDE FOR GMP REGULATORY COMPLIANCE PROGRAMME

Audit Checklist (Revision 3 including API and common with Canada and PIC/S).. [EMA]

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