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Fri, 31 Aug 2018 10:33:43 -0000 Glenn Abood Here, rfxcel CEO Glenn Abood explains how serialisation software can unlock additional value beyond regulatory compliance. https://www.epmmagazine.com/opinion/vision-and-visibility-converting-compliance-into-advantage/ https://www.epmmagazine.com/opinion/vision-and-visibility-converting-compliance-into-advantage/ Fri, 31 Aug 2018 10:33:43 -0000 Ace up the sleeve Paolo Landriani Paolo Landriani, technical department director at SEA Vision, discusses the importance of the right equipment and software in this approach and how it can save space, improve quality and ultimately save manufacturers time and money. https://www.epmmagazine.com/opinion/keeping-on-track-for-traceability/ https://www.epmmagazine.com/opinion/keeping-on-track-for-traceability/ Wed, 29 Aug 2018 11:55:29 -0000 Fast track Aflex Hose — a business division of Watson-Marlow Fluid Technology Group — has emphasized the importance of using products that are within the rules and comply with regulatory bodies’ specifications. https://www.epmmagazine.com/opinion/aflex-hose-emphasizes-importance-of-using-compliant-products/ https://www.epmmagazine.com/opinion/aflex-hose-emphasizes-importance-of-using-compliant-products/ Fri, 03 Aug 2018 09:47:47 -0000 Guidance Swiss pharmaceutical group, Helsinn, has revealed it will be investing €6 million at its drug product supply centre (Helsinn Birex Pharmaceuticals — HBP) in Dublin, Ireland, to safeguard its supply chain and compliance with regulatory requirements https://www.epmmagazine.com/news/swiss-pharma-group-invests-to-safeguard-supply-chain/ https://www.epmmagazine.com/news/swiss-pharma-group-invests-to-safeguard-supply-chain/ Wed, 30 May 2018 10:49:53 -0000 Euros Sonia Monahan Master data management promises an efficient, definitive way to address the demands of the forthcoming ISO IDMP standards for product information recording. What is involved in practice though, and how can companies ensure the investment pays off? https://www.epmmagazine.com/opinion/mastering-idmp-%E2%80%94-what%E2%80%99s-involved-in-master-data-management-a/ https://www.epmmagazine.com/opinion/mastering-idmp-%E2%80%94-what%E2%80%99s-involved-in-master-data-management-a/ Wed, 25 Oct 2017 10:00:00 -0000 Mastering IDMP The Regulatory Affairs Professionals Society (RAPS) is launching its first European Council (REC) to support its expansion and to increase its presence within the region. https://www.epmmagazine.com/news/stepping-up-to-the-european-plate-%E2%80%94-raps-launches-european-c/ https://www.epmmagazine.com/news/stepping-up-to-the-european-plate-%E2%80%94-raps-launches-european-c/ Wed, 18 Oct 2017 11:05:44 -0000 Europe Stuart Ward In this online exclusive, Stuart Ward, head of Business Analysis at R&D software provider, IDBS, looks at some of the important aspects of laboratory automation that need to be considered to maintain regulatory compliance. https://www.epmmagazine.com/opinion/can-organisations-introduce-automation-and-remain-compliant/ https://www.epmmagazine.com/opinion/can-organisations-introduce-automation-and-remain-compliant/ Mon, 09 Oct 2017 11:29:55 -0000 Lab automation Drug delivery company, Nemera, has received drug manufacturing authorisation from the German Government Drug Administration (Government Presidium, Tübingen) for its Neuenburg plant. https://www.epmmagazine.com/news/nemera-receives-drug-manufacturing-authorisation-for-its-neu/ https://www.epmmagazine.com/news/nemera-receives-drug-manufacturing-authorisation-for-its-neu/ Fri, 29 Sep 2017 10:12:14 -0000 Authorised SecurMed UK, the non-profit organisation that will manage the UK’s Medicines Verification System, has appointed Arvato Systems to meet its obligations under the falsified medicines directive (FMD) and associated delegated regulation. https://www.epmmagazine.com/news/securmed-uk-appoints-arvato-systems-to-implement-medicines-v/ https://www.epmmagazine.com/news/securmed-uk-appoints-arvato-systems-to-implement-medicines-v/ Thu, 20 Jul 2017 11:28:30 -0000 Letter of intent A recent survey, performed by NiceLabel in cooperation with Pharmaceutical Manufacturing, has revealed the importance of a single, integrated label management system to overcome challenges encountered with producing accurate and compliant labels. https://www.epmmagazine.com/news/survey-reveals-importance-of-standardisation-in-pharma-label/ https://www.epmmagazine.com/news/survey-reveals-importance-of-standardisation-in-pharma-label/ Wed, 28 Jun 2017 09:55:08 -0000 NiceLabel According to research conducted by serialisation system provider SEA Vision and life science technology specialist Zenith Technologies, technology selection is the biggest challenge for companies preparing for serialisation regulations. https://www.epmmagazine.com/news/technology-selection-is-greatest-barrier-to-serialisation-su/ https://www.epmmagazine.com/news/technology-selection-is-greatest-barrier-to-serialisation-su/ Tue, 27 Jun 2017 10:42:59 -0000 Hurdles Control Risks Companies are putting themselves at risk by failing to appropriately prioritise and resource compliance. Here, specialist risk consultancy, Control Risks, discusses its annual research report into business attitudes towards legal and compliance risk. https://www.epmmagazine.com/opinion/risking-it-all-companies-urged-to-prioritise-and-resource-co/ https://www.epmmagazine.com/opinion/risking-it-all-companies-urged-to-prioritise-and-resource-co/ Wed, 14 Jun 2017 15:37:01 -0000 Risky businessman Christoph Krähenbühl Christoph Krähenbühl, senior director at 3C Excellis Europe, talks to EPM about Europe’s readiness for the EU falsified medicines directive (EU FMD). https://www.epmmagazine.com/opinion/is-europe-ready-for-the-eu-falsified-medicines-directive/ https://www.epmmagazine.com/opinion/is-europe-ready-for-the-eu-falsified-medicines-directive/ Wed, 07 Jun 2017 11:25:04 -0000 EU FMD Felicity Thomas Contract development and manufacturing organisation (CDMO), Recipharm, has delivered its first batch of serialised drug products to Saudi Arabia. This follows the introduction of new regulatory requirements in March this year. https://www.epmmagazine.com/news/first-batch-of-serialised-drugs-delivered-to-saudi-arabia/ https://www.epmmagazine.com/news/first-batch-of-serialised-drugs-delivered-to-saudi-arabia/ Mon, 24 Apr 2017 11:11:01 -0000 Saudi Arabia flag Martyn Williams Martyn Williams, COPA-DATA UK describes how the pharmaceutical sector can get the best from technology for regulatory compliance https://www.epmmagazine.com/opinion/how-to-take-smart-steps-in-regulatory-compliance/ https://www.epmmagazine.com/opinion/how-to-take-smart-steps-in-regulatory-compliance/ Tue, 12 Jul 2016 15:52:19 -0000 regulatorycompliance.jpg Emily Hughes Maria Sharapova has failed a drugs doping test at the Australian Open. Changes in regulations mean meldonium, once a prescription drug taken by the athlete, has now been banned https://www.epmmagazine.com/opinion/sharapova-lack-of-regulation-clarity-meldonium/ https://www.epmmagazine.com/opinion/sharapova-lack-of-regulation-clarity-meldonium/ Wed, 09 Mar 2016 11:03:00 -0000 Sharapova.jpg Unless the pharmaceutical industry manages product lifecycle data holistically in 2016, companies’ ability to achieve regulatory compliance and maintain speed to market will be compromised, warns Mark Evenepoel, Group, Amplexor Life Sciences https://www.epmmagazine.com/opinion/how-to-achieve-both-regulatory-compliance-and-good-speed-to-/ https://www.epmmagazine.com/opinion/how-to-achieve-both-regulatory-compliance-and-good-speed-to-/ Fri, 19 Feb 2016 09:13:00 -0000 pg. 9.jpg Capsugel’s Steven Facer says prioritisation of quality and regulatory compliance from the start is key to achieving long-term gains for emerging markets https://www.epmmagazine.com/opinion/Quality-first-in-development-and-manufacturing/ https://www.epmmagazine.com/opinion/Quality-first-in-development-and-manufacturing/ Tue, 08 Sep 2015 08:41:00 -0000 Online.jpg Professor Sam Salek at the University of Hertfordshire has published a book for global regulatory agencies and the pharmaceutical industry to use when weighing up the benefits versus risks of bringing new medicines to market. https://www.epmmagazine.com/news/universal-framework-for-new-meds/ https://www.epmmagazine.com/news/universal-framework-for-new-meds/ Mon, 01 Jun 2015 10:06:00 -0000 Uni of Herts Romulo Leon Romulo Leon, head of global sales at Mettler-Toledo provides his take on fresh regulation challenges for pharma today. https://www.epmmagazine.com/blogs/regulatory-affairs-column/regulation-challenges/ https://www.epmmagazine.com/blogs/regulatory-affairs-column/regulation-challenges/ Wed, 22 Oct 2014 13:14:00 -0000 bottlepillsonshelf.jpg Merck Millipore has announced the availability of Millitrack Compliance, an e-solution designed to allow regulatory compliance and optimisation of laboratory performance for the company’s Milli-Q Advantage andMilli-Q Integral laboratory water... https://www.epmmagazine.com/technology/esolution-for-worldwide-water-purification-systems-compliance/ https://www.epmmagazine.com/technology/esolution-for-worldwide-water-purification-systems-compliance/ Thu, 27 Jun 2013 11:23:00 -0000 Merck