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Mon, 06 Sep 2021 09:40:00 -0000 Dr Paul Dunn, chair of the International Hologram Manufacturers Association (IHMA) considers why a product identifier initiative by itself cannot be considered an authentication solution under ISO 12931. https://www.epmmagazine.com/pharmaceutical-industry-insights/pharmaceutical-logistics-distribution/how-holography-can-complement-product-identifier-initiatives-in-pharma/ https://www.epmmagazine.com/pharmaceutical-industry-insights/pharmaceutical-logistics-distribution/how-holography-can-complement-product-identifier-initiatives-in-pharma/ Mon, 06 Sep 2021 09:40:00 -0000 pharma.barcode.gif Greenlight Guru, a medical device quality management software (MDQMS) platform, has teamed up with Nelson Labs, a provider of microbiology and analytical chemistry testing for medtech and pharmaceutical companies. https://www.epmmagazine.com/pharma-manufacturing-news/latest-pharmaceutial-news/partnership-a/ https://www.epmmagazine.com/pharma-manufacturing-news/latest-pharmaceutial-news/partnership-a/ Mon, 11 Jan 2021 09:52:31 -0000 partnership Dr Valdas Jurkauskas Dr Ke Chen The regulatory strategies pharma companies can take to avoid delay when selecting a starting materials. https://www.epmmagazine.com/pharmaceutical-industry-insights/latest-pharmaceutical-industry-insights/get-your-defence-in-early-regulatory-starting-material-desig/ https://www.epmmagazine.com/pharmaceutical-industry-insights/latest-pharmaceutical-industry-insights/get-your-defence-in-early-regulatory-starting-material-desig/ Tue, 24 Nov 2020 09:15:00 -0000 Regulations Pharmaceutical representatives have welcomed steps taken by the UK and EU on the implementation of medicine regulations in Northern Ireland. https://www.epmmagazine.com/pharma-manufacturing-news/medicines-northern-ireland/ https://www.epmmagazine.com/pharma-manufacturing-news/medicines-northern-ireland/ Mon, 09 Nov 2020 10:30:00 -0000 Backstop Monia Nica Monia Nica, senior regulatory affairs manager at Arriello, examines the relaxed measures regulatory agencies have set out due to Covid-19. https://www.epmmagazine.com/pharmaceutical-industry-insights/special-measures-a-roundup-of-pandemic-related-relaxations-t/ https://www.epmmagazine.com/pharmaceutical-industry-insights/special-measures-a-roundup-of-pandemic-related-relaxations-t/ Tue, 20 Oct 2020 09:15:00 -0000 Masks Joe Corrigan Isabel Losantos Isabel Losantos, senior consultant - Design Assurance, at Cambridge Consultants and Joe Corrigan, head of Medical Technology examine the potential AI represents in life sciences and the regulatory changes it brings. https://www.epmmagazine.com/pharmaceutical-industry-insights/the-potential-of-ai-in-medicine-and-how-it-s-changing-regula/ https://www.epmmagazine.com/pharmaceutical-industry-insights/the-potential-of-ai-in-medicine-and-how-it-s-changing-regula/ Mon, 28 Sep 2020 10:30:00 -0000 AI Regulatory and compliance consultancy, Maetrics, has released a whitepaper highlighting how the Covid-19 pandemic is affecting regulatory and quality compliance in the life science sector. https://www.epmmagazine.com/pharma-manufacturing-news/whitepaper-addresses-regulatory-changes-for-life-sciences/ https://www.epmmagazine.com/pharma-manufacturing-news/whitepaper-addresses-regulatory-changes-for-life-sciences/ Tue, 18 Aug 2020 13:30:00 -0000 Whitepaper Vanessa Fachada Vanessa Fachada Oliveira, pharmacovigilance manager & EU QPPV at Arriello, highlights key areas of focus for marketing authorisation holders to achieve an effective audit of their pharmacovigilance systems. https://www.epmmagazine.com/pharmaceutical-industry-insights/10-ways-to/ https://www.epmmagazine.com/pharmaceutical-industry-insights/10-ways-to/ Mon, 13 Jul 2020 10:00:00 -0000 Inspection Suzanne Ward Suzanne Ward, senior director of medical strategy at Boston Scientific, examines supply chains in 2020 and why patients should be aware of what's really in the medicines they take. https://www.epmmagazine.com/pharmaceutical-industry-insights/people-want-to-know-what-is-in-their-medicine/ https://www.epmmagazine.com/pharmaceutical-industry-insights/people-want-to-know-what-is-in-their-medicine/ Fri, 14 Feb 2020 11:50:00 -0000 Medicines MedPharmPlast Europe welcomed more than 50 industry experts during a two-day event in Frankfurt. https://www.epmmagazine.com/pharma-manufacturing-news/regulations-and-brexit-features-heavily-at-medpharmplast-eve/ https://www.epmmagazine.com/pharma-manufacturing-news/regulations-and-brexit-features-heavily-at-medpharmplast-eve/ Mon, 08 Jul 2019 11:26:44 -0000 auto-3.jpg Erick Gaussens Erick Gaussens, ProductLife Group’s chief scientific officer, reports on a recent pharmaceutical roundtable which examined why streamlining data management between regulatory and manufacturing needs is a pressing concern for manufacturers. https://www.epmmagazine.com/pharmaceutical-industry-insights/why-streamlining-regulatory-data-is-vital-for-pharma/ https://www.epmmagazine.com/pharmaceutical-industry-insights/why-streamlining-regulatory-data-is-vital-for-pharma/ Thu, 11 Apr 2019 08:00:00 -0000 Data Romuald Braun Amplexor’s VP of strategy for life sciences Romuald Braun asks how growing pressure on regulatory data is changing the way firms manage it and what is the best bet exploiting the transformation for the benefit of their own businesses? https://www.epmmagazine.com/pharmaceutical-industry-insights/where-is-regulatory-information-management-headed-next/ https://www.epmmagazine.com/pharmaceutical-industry-insights/where-is-regulatory-information-management-headed-next/ Thu, 22 Nov 2018 09:00:00 -0000 Data Based on its latest report, data and analytics company — GlobalData — has revealed that North Americans are the least informed about the General Data Protection Regulation (GDPR). https://www.epmmagazine.com/pharma-manufacturing-news/north-americans-are-least-informed-about-gdpr/ https://www.epmmagazine.com/pharma-manufacturing-news/north-americans-are-least-informed-about-gdpr/ Fri, 17 Aug 2018 10:47:31 -0000 North America Alex Aves In this online exclusive, Alex Aves, marketing executive, Rephine, looks at blockchain in more detail including how it may benefit the pharmaceutical sector. https://www.epmmagazine.com/pharmaceutical-industry-insights/the-application-of-blockchain-in-the-pharma-sector/ https://www.epmmagazine.com/pharmaceutical-industry-insights/the-application-of-blockchain-in-the-pharma-sector/ Wed, 02 May 2018 09:53:04 -0000 Blockchain The Medicines and Healthcare products Regulatory Agency (MHRA) has implemented changes to the licence for valproate medicines — Epilim, Depakote and generics used to treat epilepsy and bipolar disorder — in the interest of public safety. https://www.epmmagazine.com/pharma-manufacturing-news/mhra-changes-licence-for-valproate-medicines/ https://www.epmmagazine.com/pharma-manufacturing-news/mhra-changes-licence-for-valproate-medicines/ Tue, 24 Apr 2018 12:44:30 -0000 Epilepsy John Smiddy Pharmaceutical companies are unwittingly putting production processes at risk of contamination by fitting mechanical seals which fail to comply with EU regulations. says John Smiddy, European Sales and Technical Support Director for AESSEAL. https://www.epmmagazine.com/pharmaceutical-industry-insights/mechanical-seal-of-approval/ https://www.epmmagazine.com/pharmaceutical-industry-insights/mechanical-seal-of-approval/ Wed, 27 Dec 2017 09:00:00 -0000 Contamination The International Society for Cellular Therapy (ISCT) has stated its support of the US Food and Drug Administration’s (FDA’s) new comprehensive Regenerative Medicine Policy Framework. https://www.epmmagazine.com/pharma-manufacturing-news/isct-announces-support-of-fda%E2%80%99s-new-framework-for-regenerati/ https://www.epmmagazine.com/pharma-manufacturing-news/isct-announces-support-of-fda%E2%80%99s-new-framework-for-regenerati/ Tue, 21 Nov 2017 14:21:57 -0000 Support ABPI responds positively to a letter in the Financial Times from health secretary, Jeremy Hunt, and business secretary, Greg Clark, which lays out plans for the regulation of medicines in the UK after the country leaves the European Union. https://www.epmmagazine.com/pharma-manufacturing-news/abpi-responds-positively-to-government-plans-for-post-brexit/ https://www.epmmagazine.com/pharma-manufacturing-news/abpi-responds-positively-to-government-plans-for-post-brexit/ Tue, 04 Jul 2017 10:09:40 -0000 Brexit flag Felicity Thomas Arvato Systems has been tasked with the implementation and operation of the Medication Verification IT platform for the Austrian Medicines Verification Organisation (AMVO). https://www.epmmagazine.com/pharma-manufacturing-news/arvato-tasked-with-implementing-and-operating-the-verificati/ https://www.epmmagazine.com/pharma-manufacturing-news/arvato-tasked-with-implementing-and-operating-the-verificati/ Fri, 23 Jun 2017 14:30:35 -0000 Austrian flag Felicity Thomas The Food and Drug Administration (FDA), under new commissioner Scott Gottlieb, will be taking more of an active role in the issues surrounding drug prices, according to various US news sources. https://www.epmmagazine.com/pharma-manufacturing-news/drug-price-wars-fda-to-be-more-involved-in-pricing-according/ https://www.epmmagazine.com/pharma-manufacturing-news/drug-price-wars-fda-to-be-more-involved-in-pricing-according/ Wed, 07 Jun 2017 08:13:27 -0000 Drug prices Shabbir Dahod, president and CEO of TraceLink, highlights insights to take from DSCSA to help with EU FMD. https://www.epmmagazine.com/pharma-manufacturing-news/lessons-learned/ https://www.epmmagazine.com/pharma-manufacturing-news/lessons-learned/ Wed, 24 May 2017 13:15:00 -0000 Lessons Learned Felicity Thomas According to a new study published in JAMA, institutions and organisations can play a role in the relationships between doctors and the drug industry and this may affect which drugs are prescribed to patients. https://www.epmmagazine.com/pharma-manufacturing-news/institutions-play-a-part-in-doctor%E2%80%93drug-industry-relationshi/ https://www.epmmagazine.com/pharma-manufacturing-news/institutions-play-a-part-in-doctor%E2%80%93drug-industry-relationshi/ Thu, 04 May 2017 11:24:21 -0000 Relationship Felicity Thomas On 4 May, the in vitro diagnostic medical device industry will gather in Dublin for an All-Ireland IVD Symposium on the new European regulation. https://www.epmmagazine.com/pharma-manufacturing-news/may-the-fourth-be-with-you-ivd-symposium-to-take-place-in-du/ https://www.epmmagazine.com/pharma-manufacturing-news/may-the-fourth-be-with-you-ivd-symposium-to-take-place-in-du/ Wed, 03 May 2017 10:52:29 -0000 Ireland flag Torben Vogt, pharma director at Videojet Technologies, talks to EPM about implementing coding and marking systems for serialisation. https://www.epmmagazine.com/pharmaceutical-industry-insights/cracking-the-code/ https://www.epmmagazine.com/pharmaceutical-industry-insights/cracking-the-code/ Wed, 05 Apr 2017 10:35:00 -0000 Q&A Felicity Thomas Michael Gove, former cabinet minister and Conservative politician, highlighted EU regulations on clinical trials for new drugs as something that, in his opinion, holds back UK businesses. https://www.epmmagazine.com/pharma-manufacturing-news/gove-recommends-%E2%80%98taking-back-control%E2%80%99-of-uk-pharma/ https://www.epmmagazine.com/pharma-manufacturing-news/gove-recommends-%E2%80%98taking-back-control%E2%80%99-of-uk-pharma/ Wed, 29 Mar 2017 10:44:53 -0000 Brexit-control Dr. Andreas Nixdorf, business development manager, extractables and leachables testing at SGS - Life Sciences, examines new developments in safety, toxicity and E&L standards for single use manufacturing. https://www.epmmagazine.com/pharma-manufacturing-news/bio-hazard-developments-in-safety-toxicity-and-e-l-standards/ https://www.epmmagazine.com/pharma-manufacturing-news/bio-hazard-developments-in-safety-toxicity-and-e-l-standards/ Thu, 29 Dec 2016 09:00:00 -0000 Biohazard EPM catches up with Kevin Lawler, vice president of worldwide sales at Pelican BioThermal to discuss all things cold chain. https://www.epmmagazine.com/pharma-manufacturing-news/at-the-cold-face-discussing-cold-chain-logistics-with-pelica/ https://www.epmmagazine.com/pharma-manufacturing-news/at-the-cold-face-discussing-cold-chain-logistics-with-pelica/ Wed, 30 Nov 2016 15:50:00 -0000 Q&A Leslie Morgan, CEO of Durbin talks about industry regulations, Managed Access Programmes and the future of pharma https://www.epmmagazine.com/pharmaceutical-industry-insights/executive-profile-leslie-morgan-ceo-of-durbin/ https://www.epmmagazine.com/pharmaceutical-industry-insights/executive-profile-leslie-morgan-ceo-of-durbin/ Thu, 05 May 2016 14:40:21 -0000 Leslie Morgan Headshot.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/pharmaceutical-industry-insights/sharapova-lack-of-regulation-clarity-meldonium/ https://www.epmmagazine.com/pharmaceutical-industry-insights/sharapova-lack-of-regulation-clarity-meldonium/ Wed, 09 Mar 2016 11:03:00 -0000 Sharapova.jpg Farzad Henareh Farzad Henareh, Stericycle ExpertSolutions, discusses taking responsibility for product safety, regulation and classification https://www.epmmagazine.com/pharmaceutical-industry-insights/building-regs/ https://www.epmmagazine.com/pharmaceutical-industry-insights/building-regs/ Tue, 10 Nov 2015 09:42:00 -0000 EPM pg. 15 Farzad 1.jpg