The importance of Pharmacovigilance:

The collection and assessment of adverse reactions are important in the first decade after the marketing authorization of a drug. The information gathered in this period could help, for example, identify complications from its use that were unknown before its commercialization. However, when it comes to medicines that have been on the market for a ...

Rafaella’s Literature Update

Be-cause Health & QUAMED literature updates Ref (1): US Pharmacopoeia, Increasing Transparency in the Medicines Supply Chain, 2021 Ref (2): US Pharmacopoeia, Global Public Policy Position: Key Elements to Building a More Resilient Supply Chain Dear Friend, The more diffuse and fragmented the supply chain is, the greater the risk that important information about the origin, production ...

Recent resources for biologics utilized in COVID-19 treatments and vaccines available on USP website

USP has developed interesting material on quality and Covid-19. They include an infographic on production standards of Covid-19 vaccines and standards for quality assessment of COVID-19 vaccines. Follow these links for more information: Ensuring quality in monoclonal antibody development and COVID-19 Vaccine Quality Attributes Toolkits. Another great USP resource is the COVID-19 Vaccine Handling Guides. They have recently been ...

PIC/S: COVID-19 Risk Assessment for Routine On-Site Inspections

 It is interesting to see that PIC/S has adopted guidance on “COVID-19 Risk Assessment for Routine On-Site Inspections” (PI 055-1). It entered into force on 15 July 2021. Please follow the following link to the PIC/S website “Publications” https://picscheme.org/en/news to download this document. It was nice to see that the larger suppliers that we have audited ...

Webinar: The Renaissance of The African Pharmaceutical Industry

On July 8 and July 9, Dr Patrick Lukulay and Dr Prosper Hiag presented a webinar to Quamed members on the renaissance of the African pharmaceutical industry: challenges, opportunities, and how the industry is poised to locally meet more of the health needs of African populations. More than 25 of our members participated in the ...

COVID-19 Vaccines Quality Report

COVID-19 vaccines are vital interventions to help end the pandemic. However, issues with equitable global access, falsified, diverted and substandard (especially degraded) vaccines are highly likely to become increasingly global public health problems.  Read the latest Medicine Product Quality Report on substandard and falsified (SF) COVID-19 vaccines, which summarise reports in the public domain including ...

Quamed General Assembly

On Wednesday the 9th of June, QUAMED held its 5th annual meeting. Our reports and plans were all adopted. We are grateful that most of our members could participate and we would like to thank ECHO and the Global Fund for their inspiring presentations. With frank exchanges and constructive questions, we feel that we are one step ...

Pharmaceutical Patents and Monopolistic Pricing

South Africa’s struggle to increase access to anti-retroviral medications decades ago focused attention on the relationship between patent protection and high medicine prices. The COVID-19 pandemic has drawn greater attention to the cost of pharmaceutical technologies and the inequitable access to these. Globally this has raised concerns about the impact of the 1994 World Trade ...

Quamed

Notice to QUAMED members and partners

Dear members, As we near our GA meeting set on the 9th June 2021, we’d like to kindly remind you all that it is crucial to check out our latest newsletter with the membership folder that includes all the important documents you’ll need for voting. As it is a statutory requirement, be sure to check it ...

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