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On-demand webinar: What you need to know about USP <1085>
Watch the webinar that analyses the most important points introduced by the newest USP Chapter 1085 on endotoxin testing guideline and their impact.
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EMA recommends 10 medicines for approval in October meeting
Ten medicines have been recommended for marketing authorisation and 10 extensions of indication have been suggested by the EMA.
webinar
Liquid-filled hard capsules: A flexible tool for rapid access to the clinic with poorly soluble and/or highly potent compounds
21 October 2020 | By Lonza Pharma & Biotech
Watch our on-demand webinar to learn about liquid-filled hard capsule technology has a proven record for addressing complex active pharmaceutical ingredient (API) formulation challenges, including bioavailability enhancement.
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Expert view: The right endotoxin detection solution for you – bioMérieux’s complete portfolio of rFC endotoxin assays
As part of any general pyrogen testing strategy, the detection of even minute traces of the highly pyrogenic bacterial molecule called lipopolysaccharide (LPS, also named endotoxin) in pharmaceutical samples is mandatory to ensure patient safety.
whitepaper
Whitepaper: Streamlining pharma operations in the wake of COVID-19
Find out how to streamline your pharmaceutical operations in a COVID-19 environment.
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Formulation, Development & Delivery In-Depth Focus 2020
In this in-depth focus experts provide guidance on how to select starting materials for API's and discuss how to specify exipients to reduce downstream regulatory burdens.
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Guide to Outsourcing
Welcome to European Pharmaceutical Review’s Guide to Outsourcing. In this edition, Eurofins Scientific, SGS Life Sciences, Charles River Laboratories, ACCI, Eurofins Amatsi Group and Thermo Fisher Scientific showcase their unique outsourcing services and discuss how they stand out from the competition.
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European Pharmaceutical Review Issue 5 2020
In this issue you can find articles discussing the supply chain implications of Trump's 'Buy American' order, guidance on how to identify and justify starting materials for regulatory approval by both the EMA and FDA, as well as some of the latest developments in oral biologic drug delivery techniques. Also…
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Speeding processes and enhancing compliance with pharmacovigilance automation
Dr John Price explains how life sciences companies are making progress with pharmacovigilance automation and how a new study of pharmaceutical organisations has uncovered potential for improvement in the capture of adverse event data.
news
J&J pauses COVID-19 vaccine clinical trial after participant illness
J&J has paused its Phase III trial for its COVID-19 vaccine candidate following an unexplained illness in a study participant.
webinar
Pharmacopoeia changes – what to check for on UV/Vis spectrometers, and how.
12 October 2020 | By Mettler-Toledo GmbH and Hellma GmbH & Co. KG
Watch the on-demand webinar to learn about the important UV/Vis spectroscopy-relevant changes in both USP and Ph. Eur. taking a closer look at their impact and the solutions available to ensure compliance.
news
NICE to simplify how medicines are selected for evaluation
NICE has launched a public consultation for suggestions on updating how it selects the topics to develop guidance on, to improve medicine evaluations.
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Reality check: is robotic process automation a panacea for transforming regulatory affairs?
Regulatory operations are burdened by resource-draining document and data processing tasks, but is robotic process automation the definitive solution? If not, where does it have greatest application and appeal – and how can life sciences firms exploit the full benefits? Agnes Cwienczek scrutinises the technology’s potential.
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FDA issues guidance for COVID-19 vaccine Emergency Use Authorizations
The FDA has released new guidance for sponsors regarding Emergency Use Authorizations for potential COVID-19 vaccines.
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Lopinavir-ritonavir not an effective treatment for COVID-19, study shows
A clinical trial in the UK has shown that lopinavir-ritonavir is not an effective treatment for patients admitted to hospital with COVID-19.
