The Virtual cGMP Training Marathon for Vaccine Manufacturing: Principles into Practice took place from 12 Sep to 10 Oct 2023 to continue to provide manufacturers & regulators with a comprehensive array of topics to build understanding of current WHO & international GMP standards, technological advan...cements, industry practices and regulatory expectations specific to the vaccine manufacturing context. Some of the topics include computer system validation, data integrity, challenges in lyophilization and others. Real world examples and case studies will be used to show how to interpret current and recently new good manufacturing practices requirements from a practical point of view and to implement appropriate approaches.
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ECDC is now offering a series of micro learning activities related to COVID-19 (the disease causing the 2019 novel coronavirus outbreak). The e-learning activities are available in the ECDC Virtual Academy (EVA). https://eva.ecdc.europa.eu/mod/scorm/view.php?id=9691
The short e-learning activitie...s provide guidance on the application of non-pharmaceutical countermeasures and include five sessions.
1. Introduction to COVID-19 NPC
2. Personal protection against COVID-19
3. Environmental countermeasures against COVID-19
4. Social distancing countermeasures against COVID-19
5. Travel-related countermeasures against COVID-19
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This document provides guidance on the application of non-pharmaceutical countermeasures to minimise the spread of the 2019 novel coronavirus (2019-nCoV) in the population. Some of the measures proposed refer specifically to certain phases of the epidemic (containment or mitigation phases), and can ...be adapted depending on the assessed severity/impact of the infection. Other measures are valid for all phases of an epidemic.
The guidance is based on the current knowledge of the 2019-nCoV and evidence available on other viral respiratory pathogens, mainly the Severe Acute Respiratory Syndrome coronavirus (SARS-CoV), the Middle East Respiratory Syndrome-related coronavirus (MERS-CoV) and seasonal or pandemic influenza viruses.
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Rwanda Guidelines for variation to registered pharmaceutical products.
The MSF qualification scheme is concerned with the pharmaceutical quality assessment for drugs. This procedure is applicable to products for international supply, i.e. products supplied through the MSF procurement centres. This qualification procedure is not applicable for local purchase, i.e. purch...ase of drugs within the project countries. For quality assurance principles and assessment of drugs for local purchase refer to the guideline for local pharmaceutical market assessment.
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This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
Dans le cadre du projet Tracmed, une étude sur les outils législatifs et juridiques à disposition des ordres des pharmaciens dans la lutte contre les médicaments falsifiés a été réalisée en juillet 2015. Cette étude porte sur le Bénin, le Burkina Faso, la Guinée et le Mali.
Drug Distribution and Control: Preparation and Handling
This Technical Assistance Bulletin is intended to assist pharmacists in the extemporaneous compounding of non-sterile drug products for individual patients. Included in this document is information on facilities and equipment, ingredient... selection, training, documentation and record keeping, stability and beyond-use dating, packaging and labeling, and limited batch compounding. This document is not intended for manufacturers or licensed repackagers.
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