ECDC launched the HEPSA (Health Emergency Preparedness Self-Assessment) tool, in order to support countries in improving their level of public health emergency preparedness. The tool is worksheet-based and is targeted at professionals in public health organisations responsible for emergency planning... and event management. It consists of seven domains that define the process of public health emergency preparedness and response: 1) Pre-event preparations and governance; 2) Resources: Trained workforce; 3) Support capacity: Surveillance; 4) Support capacity: Risk assessment; 5) Event response management; 6) Post-event review; 7) Implementation of lessons learned.
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This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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National emergency medical teams are the best option for providing immediate and appropriate surge response for emergencies directly affecting populations, while international teams may help relieve overwhelmed health systems. The efficiency and effectiveness of countries and local authorities in mo...bilizing existing resources is only as good as the quality of care they are able to provide. This publication serves as a practical guide for teams and aims to compliment emergency response systems, fostering seamless collaboration with all emergency response actors and networks
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DRUGS REGULATORY UNIT | NOVEMBER 2009 | SECOND EDITION
First Revised Edition
March 2000
The purpose of this report is to provide an overview of the issues in regulating and managing international emergency in a selection of large and small-scale sudden onset disasters (SODs). In doing so, it aims to contribute to several key international commitments as well as its objective in disaste...rs and emergencies to “reduce the consequences the event may have on world health and its social and economic implications”.
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