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Make confident operational decisions by understanding your microflora
Are you leveraging all the information from your QC data? A secure, compliant and powerful data management tool is critical for maintaining a state of control.
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Regulation & Legislation
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An Annex 1 and Pharma 4.0 perspective on water quality
Pharma 4.0 is coming and is further driven by the recent update of the EU GMP Annex 1 regarding manufacturing of sterile medical products, setting new regulatory expectations in all manufacturing processes. Here, Isabella Jul-Jørgensen from the University of Denmark focuses on sterile water quality and how the new requirements…
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Patents: a necessary evil?
Dave Elder explores US patent developments amid growing concerns that current approaches potentially delay generic drugs and biosimilars entering the market.
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EC approves CAR T-Cell therapy for B-cell lymphoma
Yescarta approved by EC for the treatment of large B-Cell lypmphoma and high grade B-cell lymphoma.
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CHMP recommends Pluvicto® for treating advanced prostate cancer
CHMP issues positive opinion on Pluvicto®, paving the way for it to become the first European-approved radioligand therapy for metastatic prostate cancer patients.
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NICE partners with health technology assessment bodies
Five health technology assessment (HTA) bodies will collaborate with NICE to help resolve regulatory and digital health technology challenges.
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Pilot to support ATMP research and development
Five academic and non-profit organisations developing advanced therapy medicinal products (ATMPs) will benefit from the European Medicines Agency’s (EMA) scheme.
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Sharing data on human tissue availability across EU
The Council of Europe encourages EU Member States to share tissue and cell availability data to support donation access and State self-sufficiency.
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Economics and risks of FDA’s Quality management maturity rating programme
Ensuring that pharmaceutical manufacturers not only adhere to current good manufacturing processes but go beyond to embrace a culture of quality has far-reaching consequences for the industry, the health care community and consumers. A focus on quality across many sectors of the economy has demonstrated direct economic benefits accruing to…
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Medicinal cannabis monograph proposed by US Pharmacopeia
A monograph outlining the analytical methods and acceptance criteria for cannabis chemotypes has been released for comment by USP’s Herbal Medicines Compendium.
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New ethical guidance for paediatric clinical trials
New draft guidance by the US Food and Drug Administration (FDA) evaluates the ethics of children participating in clinical studies.
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On-demand webinar: Effective contamination control strategy
Discover the significance of accurate microbial identifications in building an effective contamination control strategy to keep up with the latest regulatory requirements.
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Ultomiris for generalised myasthenia gravis
The first and only long-acting C5 inhibitor, Ultomiris (ravulizumab), has been permitted in Europe for adults with generalised myasthenia gravis.
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Guide: Rapid microbial detection methods
Plate counting falls short in reducing the risk of contamination during pharmaceutical production. Learn more about rapid microbiological methods.
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EMA human medicines committee (CHMP) highlights, September 2022
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval, including those for rare diseases, osteoporosis and cancer.
