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Press release: Telstar: 360 degrees GMP consultancy & engineering solutions at CPhI
Telstar promotes innovative aseptic production solutions in a setting marked by the new GMP Annex 1.
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Regulation & Legislation
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Toolkit: Nitrosamine analysis workflows
Everything you need to have confidence and compliance in your nitrosamine impurity analysis.
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Maintaining EU MDR certification: a spotlight on post‑market clinical follow-up
Celeste Maksim, Chief of Staff, Clinical and Post-Market Practice, RQM+ advises on strategising for PMCF compliance, highlighting areas to prioritise to ensure an efficient process.
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FDA authorises Comirnaty® for emergency use in five to 11 year olds
The US Food and Drug Administration has authorised the emergency use of COVID-19 vaccine Comirnaty in children aged five to 11 years.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Oct 2021
EMA's drug safety committee (PRAC) assessed risks with COVID-19 vaccines and identified no risk of death with Imbruvica and ACE inhibitors.
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Designing an ATMP manufacturing facility: from concept to completion
Remy Martin, business development specialist at cell and gene therapy manufacturing consultant, eXmoor Pharma, discusses 10 key considerations when creating a manufacturing facility, to ensure it meets requirements for both immediate needs and future growth.
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CHMP recommends COVID-19 vaccine Spikevax booster dose
The European Medicines Agency (EMA)'s human medicines committee (CHMP) concludes that a booster dose of Spikevax can be administered in adults aged 18 or over.
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Towards a solution for the access challenges faced by combination treatments
In this article, Takeda UK present their Value Attribution and Voluntary Arbitration Frameworks, a potential solution for the combination treatment challenge.
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Product hub: Documentation at your fingertips
Digitalised Eppendorf products support customers on their way to a paperless lab whilst in compliance with good laboratory practice (GLP).
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Co-creating solutions that advance global health innovation – IFPMA’s role
The COVID-19 pandemic has altered and continues to shape our lives. Here, Thomas B Cueni, Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), gives insight into how the pandemic gave impetus to the organisation’s manifesto to innovate and save lives.
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Brochure: The new Sievers M500 online TOC analyser
The Sievers reagentless membrane conductometric TOC detection method delivers reliable, robust and accurate data for pharmaceutical water applications.
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NICE does not recommend tucatinib in new draft guidance
The UK regulator concluded that breast cancer patients taking tucatinib live longer, but it is unclear how long for and whether it is cost effective.
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Less than lifetime limits for N-nitrosamine mutagenic impurities
Here, Dave Elder discusses the determination of less than lifetime (LTL) limits for highly potent N-nitrosamine compounds and how to ensure safety in dosing.
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CHMP initiates rolling review of molnupiravir for COVID-19
The European Medicines Agency's human medicines committee (CHMP) begins its rolling review of the investigational oral antiviral molnupiravir.
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Case study: Delivering a world class cell and gene therapy suite
RoslinCT and Connect 2 Cleanrooms have worked in partnership to deliver a world-class cell and gene therapy facility.
