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8 August 2018 | By SUEZ
Data integrity and 21 CFR Part 11/EU Annex 11 requirements are hot topics when ageing analytical equipment is to be replaced. Common questions from pharma and biopharmaceutical manufacturers include: is the new technology compliant with auditor expectations? Can we get the right data saved the right way in the right…
7 August 2018 | By Mike Stones
Maintaining public confidence in the use of Big Data for health research is essential, according to international researchers.
3 August 2018 | By European Pharmaceutical Review
“Patients will now have an approved therapy that has been shown to decrease the need for blood pressure medication and reduce tumour size in some patients.”
24 July 2018 | By Mike Stones
The pharmacovigilance of new drugs and drug formulations undertaken in New Zealand should be proactive, says a leading expert.
23 July 2018 | By RWS Life Sciences
RWS Life Sciences welcomes Clarice Streets, ASQ, CMQ, OE, as Vice President, Global Quality and Process, in charge of the strategic direction and implementation of its Quality system, underlying organisational processes, and change management...
19 July 2018 | By Mike Stones
The EU and Japan have agreed to widen the range of medicines for which they will recognise each other’s inspections of manufacturing sites.
19 July 2018 | By Dave P Elder, Mike Stones
More guidance is needed on the appropriate control of non-mutagenic impurities during clinical development, explains Dave P Elder, JPAG Member and pharmaceutical industry consultant, in this audio interview.
16 July 2018 | By OSIsoft
Big data covers every facet of our working life. Every aspect of pharmaceutical research and development involves the generation of huge quantities of data, with the expectation that we can turn this information rapidly into useful knowledge, which in turn can be used to make ‘data-driven’ decisions to better understand…
16 July 2018 | By Dr Zara Kassam (European Pharmaceutical Review)
The US Food and Drug Administration has approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox...
13 July 2018 | By Dr Zara Kassam (European Pharmaceutical Review)
A trade deal between the UK and USA could risk increasing drug prices in the UK, which could diminish the affordability and accessibility of the NHS...
10 July 2018 | By SUEZ
The United States Pharmacopeia and National Formulary (USP-NF) has been the official compendia under the United States Food and Drug Administration (FDA) since the Pure Food and Drug Act of 1906...
28 June 2018 | By European Pharmaceutical Review
The FDA has approved Epidiolex oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy...
25 June 2018 | By European Pharmaceutical Review
The FDA has approved the inclusion of new evidence that Cosentyx significantly slows the progression of joint structural damage..
22 June 2018 | By European Pharmaceutical Review
In this issue: Microfluidics technology in pharmaceutical research, drug manufacturing and development, and is supercritical fluid chromatography applicable to achiral separations?
19 June 2018 | By European Pharmaceutical Review
The FDA has approved the first generic versions of Suboxone sublingual film for the treatment of opioid dependence...
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