Luigi De Rosa http://www.luigiderosa.it Pharmaceutical Quality Assurance Fri, 01 Dec 2017 17:04:18 +0000 en-US hourly 1 https://wordpress.org/?v=4.9.2 https://i1.wp.com/www.luigiderosa.it/wp-content/uploads/2017/07/Immagine2.png?fit=32%2C32 Luigi De Rosa http://www.luigiderosa.it 32 32 EU, Japan and US: a single development programme for new antibiotics http://www.luigiderosa.it/eu-japan-and-us-a-single-development-programme-for-new-antibiotics/ Mon, 27 Nov 2017 13:54:36 +0000 http://www.luigiderosa.it/?p=892 Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), met in Tokyo last month to plot out an approach that would allow drugmakers to conduct a single development plan for new antibiotics.Read More →

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EDQM publishes the final report of its Pharmaceutical Care Quality Indicators Project http://www.luigiderosa.it/edqm-publishes-the-final-report-of-its-pharmaceutical-care-quality-indicators-project/ Wed, 08 Nov 2017 07:14:11 +0000 http://www.luigiderosa.it/?p=862 The EDQM has just published the final report of its Pharmaceutical Care Quality Indicators Project.Read More →

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Eight European drug regulatory authorities will be able to conduct FDA GMP inpsections http://www.luigiderosa.it/eight-european-drug-regulatory-authorities-will-able-conduct-fda-gmp-inpsections/ Wed, 01 Nov 2017 07:35:35 +0000 http://www.luigiderosa.it/?p=849 The U.S. Food and Drug Administration will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. Read More →

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You could finally use CEP in Brazil http://www.luigiderosa.it/finally-use-cep-brazil/ Fri, 13 Oct 2017 10:14:26 +0000 http://www.luigiderosa.it/?p=843 The European Directorate for the Quality of Medicines & HealthCare (EDQM) and ANVISA, the Health Surveillance Agency of Brazil, have signed a Memorandum of Understanding which lays the foundation for ANVISA to consider the use of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) for their evaluation of marketing authorisation applications (MAAs) for medicinal products.Read More →

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Similarity by Design: comparative Assessment of Quality Attributes – EMA Reflection Paper http://www.luigiderosa.it/similarity-by-design-comparative-assessment-of-quality-attributes-ema-reflection-paper/ Thu, 05 Oct 2017 06:49:30 +0000 http://www.luigiderosa.it/?p=812 The reflection paper provides current regulatory considerations regarding statistical aspects for the comparative assessment of quality attributes in the settings of pre- and post-manufacturing change, biosimilar development as well as generics development.Read More →

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10.000 take part to the world-first trial for universal flu vaccine http://www.luigiderosa.it/10-000-take-part-to-the-world-first-trial-for-universal-flu-vaccine/ Wed, 04 Oct 2017 12:03:12 +0000 http://www.luigiderosa.it/?p=802 Scientists at Oxford University have successfully tested a universal flu vaccine that could work against all known strains of the illness, taking a significant step in the fight against a disease that affects billions of people each year.Read More →

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Advancement of Emerging Technology: FDA Guidance http://www.luigiderosa.it/advancement-emerging-technology-fda-guidance/ Mon, 02 Oct 2017 09:34:14 +0000 http://www.luigiderosa.it/?p=774 In recent years, we've seen significant advances in the modernization of drug manufacturing, including shifts to continuous manufacturing and the first 3D printed drug. These advancements have led to improved products for patients and consumers and the opportunity to have a more stable and lower cost supply chainRead More →

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FDA: ‘Broken’ Clinical Trials System and Real World Evidence http://www.luigiderosa.it/fda-broken-clinical-trials-system-and-real-world-evidence/ Mon, 25 Sep 2017 08:36:30 +0000 http://www.luigiderosa.it/?p=751 In a presentation at a workshop at the National Academies of Sciences, Engineering and Medicine, FDA Center for Drug Evaluation and Research's Janet Woodcock said the current clinical trials system is "broken" and there needs to be new ways to collect and utilize patient data.Read More →

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API starting materials – New Q&A document for ICH Q11 http://www.luigiderosa.it/api-starting-materials-new-qa-document-for-ich-q11/ Wed, 13 Sep 2017 08:14:36 +0000 http://www.luigiderosa.it/?p=721 The selection of a starting material for the synthesis of an active substance and its justification is often one of the most crucial steps in the approval process. Assessors at regulatory agencies of the EU member states have to evaluate whether the data provided sufficiently justify the selection. The criteria for this are outlined in the 2012 ICH Q11 guideline - however, not in a sufficiently precise manner.Read More →

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Process Validation never ends http://www.luigiderosa.it/process-validation-never-ends/ Mon, 11 Sep 2017 08:59:03 +0000 http://www.luigiderosa.it/?p=675 It was 2011 when FDA published their Guidance for Industry: Process Validation: General Principles and Practices.
This document radically changed FDA interpretation of process validation.
According to the guidelines validation means “the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.” It will no longer be a formalized activity that is limited in time and, typically, to three validation batches.Read More →

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