news
EMA’s first critical medicines list for COVID-19
The approved COVID-19 vaccines and treatments on the list will be monitored to prevent and mitigate the impact of shortages.
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Regulation & Legislation
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Inflation/cost of goods major concerns for pharma manufacturing
Pharma industry calls for support as restrictive pricing measures and rising costs of goods/inflation could undermine the availability of medicines.
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What lies ahead for IDMP?
The EU’s identification of medicinal products (IDMP) standards implementation was all set to go ahead, when the EMA suddenly announced a change of plan. The DADI user interface will now enable structured data submissions for the EMA PMS, at least for the near future. Drawing on recent dialogue with the…
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Case study: Reduce plate counts with rapid microbial monitoring
Find out how a pharma company maintained product quality and reduced plate counts by 25 percent using a rapid microbial monitoring analyser – the 7000RMS.
webinar
Digital versus digitised: common misconceptions about eConsent
6 June 2022 | By Medable
Learn about the common misconceptions surrounding eConsent, as well as the benefits they can realise through a digitally-enabled approach.
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ebook: Proactive clinical supply planning
The importance of thoroughly planned resupply strategies in maintaining clinical supply inventories as studies move into late phase.
![Metformin 500mg white tablets on white background [Credit: LeviMax/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Metformin-nitrosamines-300x278.jpg)
![Metformin 500mg white tablets on white background [Credit: LeviMax/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Metformin-nitrosamines-e1654079013697.jpg)
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Majority of metformin drugs have acceptable nitrosamine levels, finds study
With recalls on metformin products containing nitrosamines ongoing, a study suggests >80 percent of metformin APIs and final drug products are within safe limits.
whitepaper
Executive summary: Building a patient centric clinical supply chain
Learn strategies to improve supply chain efficiency, reduce risk and respond to local, regional and global challenges.
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Emergent destroyed almost 400mn COVID-19 vaccines due to quality issues, finds report
US Government investigation report suggests Emergent Biosolutions destroyed almost 400 million doses of COVID-19 vaccine and worked to conceal quality issues from the FDA.
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ebook: Early drug development strategies for clinical success
Learn the benefits of collaboration between the pharmaceutical scientists and clinical supply services teams.
webinar
Implementing state of the art technology to characterise polysaccharide vaccines
12 May 2022 | By Bruker
In this on-demand webinar, experts will discuss state of the art technology to characterise polysaccharide vaccines and relative implementation in biopharma development and manufacturing.
whitepaper
Whitepaper: Data integrity and 21CFR.11 for 7000RMS implementation
Learn about 21CFR.11 and Annex 11 requirements and how you can implement a rapid bioburden analyser designed to meet compliant operation needs.
whitepaper
Article: Strategies for comparator sourcing
Best practices for leveraging the resources of sourcing vendors are vital to anticipating and avoiding clinical supply delays.
news
Fenfluramine found effective in preventing drop seizures from LGS
Phase III trial shows fenfluramine as an adjunct to existing anti-epileptic treatment is effective in reducing the frequency of drop seizures from Lennox-Gastaut Syndrome (LGS).
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The latest on pharmaceutical counterfeiting
Here, EPR’s Hannah Balfour discusses the latest reports on pharmaceutical counterfeiting and falsification, exploring global and European crime rates, as well as recent counterfeiting incidents reported by Big Pharma.
