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Relevant bibliographies by topics / Summary of Product Characteristics (SmPC)

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Academic literature on the topic 'Summary of Product Characteristics (SmPC)'

Author: Grafiati

Published: 20 February 2023

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Journal articles on the topic "Summary of Product Characteristics (SmPC)"

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Drelich, Ewelina, Urszula Religioni, Kevin Chung, et al. "The Quality and Reliability of Information in the Summaries of Product Characteristics." International Journal of Environmental Research and Public Health 19, no. 4 (2022): 2185. http://dx.doi.org/10.3390/ijerph19042185.

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The Summary of Product Characteristics (SmPC) is an obligatory document concerning a medicine required (among other things) for the authorization of a medicinal product. The purpose of the SmPC is to provide product information to healthcare professionals. A necessary condition for this is to ensure that the SmPC is clear and precise. However, neither European nor national legislation obliges marketing authorization holders to review the SmPC in terms of its readability and understandability prior to the registration of a medicine. To date, research on SmPCs has focused on accuracy and complet

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Milchior, Richard. "Impact of Court Cases on Summary of Product Characteristics Harmonisation." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 2, no. 3 (2005): 240–51. http://dx.doi.org/10.1057/palgrave.jgm.4940075.

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This paper deals with the evolution of European Court of Justice (ECJ) case law. The ECJ had to decide in the Artedogan case whether the national authorities or the Commission should be able to modify marketing authorisation granted at the national level. The ECJ decided that in the situation where the marketing authorisation was of national origin, a modification could not be decided on by the European Commission on the basis of the then article 15a of directive 75/189 (today article 36 of directive 2001/83). The debate has now shifted, and the new issue is to decide who is authorised to forc

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Raynor, David K., Peter De Veene, and David Bryant. "The Effectiveness of the Summary of Product Characteristics (SmPC) and Recommendations for Improvement." Therapeutic Innovation & Regulatory Science 48, no. 2 (2014): 255–65. http://dx.doi.org/10.1177/2168479013501311.

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Bergman, Erik, Kim Sherwood, Markus Forslund, Peter Arlett, and Gabriel Westman. "A natural language processing approach towards harmonisation of European medicinal product information." PLOS ONE 17, no. 10 (2022): e0275386. http://dx.doi.org/10.1371/journal.pone.0275386.

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Product information (PI) is a vital part of any medicinal product approved for use within the European Union and consists of a summary of products characteristics (SmPC) for healthcare professionals and package leaflet (PL) for patients, together with the product packaging. In this study, based on the English corpus of the EMA product information documents for all centrally approved medicinal products within the EU, a BERT sentence embedding model was used together with clustering and dimensional reduction techniques to identify sentence similarity clusters that could be candidates for standar

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Dey, M., K. Bechman, C. Smith, A. Cope, E. Nikiphorou, and J. Galloway. "AB0649 INFECTION PROFILE OF IMMUNE-MODULATORY DRUGS USED IN AUTOIMMUNE DISEASES: ANALYSIS OF SUMMARY OF PRODUCT CHARACTERISTIC DATA." Annals of the Rheumatic Diseases 80, Suppl 1 (2021): 1357.2–1358. http://dx.doi.org/10.1136/annrheumdis-2021-eular.2207.

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Background:The number of immune-modulatory drugs used to treat immune-mediated inflammatory diseases (IMIDs) has exponentially increased in recent decades. While effective in controlling disease, serious infection remains a concern.Accurate information on immune-modulatory drugs, including infections, is required to guide prescribing decisions. The “summary of product characteristics” (SmPC) by the European Medicines Agency (EMA) provides a useful repository of information on adverse events e.g. infections, from clinical trials and post-marketing pharmacovigilance (1).To date, no comparison ha

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&NA;. "The EMA's CHMP is recommending updates to Summary of Product Characteristics (SmPC) of agomelatine [Thymanax, Valdoxan],." Reactions Weekly &NA;, no. 1421 (2012): 4. http://dx.doi.org/10.2165/00128415-201214210-00013.

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Wermuth, Maria-Cornelia. "Language localization in scientific drug information." Journal of Internationalization and Localization 3, no. 1 (2016): 74–94. http://dx.doi.org/10.1075/jial.3.1.05wer.

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Although localization is, in the first place, related to the cultural adaptation and translation of software and websites, it is important for written materials as well. In this paper we investigate how specialized medical discourse used in the Summary of Product Characteristics (SmPC) is localized in patient leaflets (PL). Both documents are issued by the European Medicines Agency (EMA) and provide detailed information on the product compiled and distributed by the drug manufacturer, after EMA review and approval. We describe by means of a case study the formal and linguistic features of SmPC

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Charnock, James, Alec Bruce, and Caroline Anger. "Dose variation in metastatic breast cancer: Are European Medicines Agency summary of product characteristics (SmPC) being followed?" Journal of Clinical Oncology 33, no. 15_suppl (2015): e11581-e11581. http://dx.doi.org/10.1200/jco.2015.33.15_suppl.e11581.

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Nederlof, Mariëtte, Lennart J. Stoker, Toine CG Egberts, and Eibert R. Heerdink. "Instructions for clinical and biomarker monitoring in the Summary of Product Characteristics (SmPC) for psychotropic drugs: Overview and applicability in clinical practice." Journal of Psychopharmacology 29, no. 12 (2015): 1248–54. http://dx.doi.org/10.1177/0269881115609016.

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Drenska, M., and I. Getov. "Research on Approaches for Regulation of the “Off-label” use of Medicinal Products in the European Union." Acta Medica Bulgarica 44, no. 1 (2017): 17–21. http://dx.doi.org/10.1515/amb-2017-0003.

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Abstract Despite the increasingly strict legislation on medicinal products, the „off-label use“ or „use of medicinal product outside the approved summary of product characteristics (SmPC)“ is a weak point of today’s drug regulation and raises many questions about the risk, ethics, and legality of this type of practice. In recent years, through guidance and legal changes in some countries were defined the conditions and responsibilities, but in the most European countries still lack rules for off-label prescribing. The purpose of this study was to identify and analyse different approaches to re

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Dissertations / Theses on the topic "Summary of Product Characteristics (SmPC)"

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Yuan, Hsiu-Chun. "Optimising written medicine information for prescription medicines." Thesis, University of Sydney, 2020. https://hdl.handle.net/2123/23676.

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Optimising written medicine information for prescription medicines Aims: to improve the current and recently revised Australian Therapeutic Goods Administration (TGA) Product Information for prescription medicines (AUS-PI and TGA-AUS-PI, respectively) and recommend a PI format for the future. All current AUS-PI are expected to adopt the revised TGA format by the end of 2020. Methods: The overall study consisted of 3 stages – needs analysis (qualitative interviews with pharmacists n=16, GPs n=9), user testing with HCP students, and user testing with HCPs. Five rounds of face-to-face user-test

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Books on the topic "Summary of Product Characteristics (SmPC)"

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Nichols, Eve K. Expanding access to investigational therapies for HIV infection and AIDS: March 12-13, 1990, conference summary. National Academy Press, 1991.

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Carrier, Tyler J., Adam M. Reitzel, and Andreas Heyland, eds. Section 1 Summary—Evolutionary Origins and Transitions in Developmental Mode. Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780198786962.003.0006.

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Abiotic variables and biotic interactions can act on variation in life history traits, ultimately leading to divergence in reproductive mode. Marine invertebrates have a remarkable diversity in such strategies, sometimes even between closely related species. It is this natural diversity that lends itself to employing a powerful comparative approach, both for particular morphological characteristics as well as molecular signatures from developmental genes. For example, complex life histories, where a larval stage is interposed between the embryo and juvenile, likely represent the product of num

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Book chapters on the topic "Summary of Product Characteristics (SmPC)"

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Nahler, Gerhard. "summary of product characteristics (SPC, SmPC)." In Dictionary of Pharmaceutical Medicine. Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_1362.

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Morgan, Michael M., MacDonald J. Christie, Luis De Lecea, et al. "Summary of Product Characteristics." In Encyclopedia of Psychopharmacology. Springer Berlin Heidelberg, 2010. http://dx.doi.org/10.1007/978-3-540-68706-1_698.

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Rubrichi, Stefania, Silvana Quaglini, Alex Spengler, and Patrick Gallinari. "Extracting Information from Summary of Product Characteristics for Improving Drugs Prescription Safety." In Artificial Intelligence in Medicine. Springer Berlin Heidelberg, 2011. http://dx.doi.org/10.1007/978-3-642-22218-4_42.

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Eiermann, Birgit, Daniel Rodrigues, Paul Cohen, and Lars L. Gustafsson. "An Adverse Drug Reaction Database for Clinical Use – Potential of and Difficulties with the Summary of Product Characteristics." In Studies in Health Technology and Informatics. IOS Press, 2022. http://dx.doi.org/10.3233/shti220499.

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Adverse drug reactions (ADRs) for all drugs in Europe are described in the legally approved Summary of Product Characteristics (SmPC). An overview of all ADRs of the patients’ drug list can support healthcare staff to link patient symptoms to possible ADRs. We review the possibilities and challenges to extract ADR information from SmPCs and present the development of our semi-automated procedure for extraction of ADRs from the tabulated section of the SmPCs to create a database, named Bikt, which is regularly updated and used at point of care in Sweden. The existence of five major table formats for ADRs used in the SmPCs required the development of different parsing scripts. Manual checks for correctness for all content has to be performed. The quality of extraction was investigated for all SmPCs by measuring precision, recall and F1 scores (i.e. the weighted harmonic mean of precision and recall) and compared with other methods published. We conclude that it is possible to semi-automatically extract ADR information from SmPCs. However, clear technical and content guidelines and standards for ADR tables and terms from drug registration authorities would lead to improved extraction and usability of ADR information at point of care.

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"Summary of Product Characteristics." In Encyclopedia of Psychopharmacology. Springer Berlin Heidelberg, 2015. http://dx.doi.org/10.1007/978-3-642-36172-2_200037.

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"Summary of product characteristics." In Pharmaceutical Medicine, edited by Adrian Kilcoyne, Phil Ambery, and Daniel O'Connor. Oxford University Press, 2013. http://dx.doi.org/10.1093/med/9780199609147.003.0027.

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"11 Investigator’s Brochure/Summary of Product Characteristics." In Guide for Investigator Initiated Trials. KARGER, 2011. http://dx.doi.org/10.1159/000328097.

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Chronaki, Catherine, Craig Anderson, Jens Kristian Villadsen, et al. "An Agile Approach to Accelerate Development and Adoption of Electronic Product Information Standards." In Studies in Health Technology and Informatics. IOS Press, 2022. http://dx.doi.org/10.3233/shti220547.

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The Medical Product Information found in most medication boxes offer a wealth of information, including terms of active ingredients, excipients, indications, dosage, route of administration, risks, and safety information. Digital health services that help patients, their care givers, and health professionals to manage medication, can be improved with tailored information based on user profile, the patient’s Electronic Health Record (EHR) summary, and Medicinal Product Information. The electronic Product information (ePI) comprises the summary of product characteristics, package leaflet, and product label. The European Medicines Agency released in 2021 the first version of the EU proof-of-concept ePI standard based on HL7 FHIR. The Gravitate-Health project uses this common standard as a springboard to implement a federated open-source platform and services that helps advance access, understanding, and adherence by providing trusted medicinal information in an interoperable and scalable way. In this paper, we present the agile technical approach and co-creation process to design, test, and progressively mature interoperability working with the HL7 Vulcan Accelerator and FHIR connectathons.

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"Carbon and Low Alloy Steels for Pressure Containing and Structural Parts." In Steel Castings Handbook, 6th ed. ASM International, 1995. http://dx.doi.org/10.31399/asm.tb.sch6.t68200233.

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Abstract The design stresses for most pressure-containing structural application, which are based upon minimum mechanical properties designated in the specifications published by the American Society for Testing and Materials (ASTM). This chapter reviews metallurgical characteristics and their influence on the properties and performance of structural carbon and low alloy steels and contains a summary of the relevant features of the ASTM product specifications.

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Hamzaçebi, Coşkun. "Taguchi Method as a Robust Design Tool." In Quality Control in Intelligent Manufacturing [Working Title]. IntechOpen, 2020. http://dx.doi.org/10.5772/intechopen.94908.

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Taguchi Method is a powerful technique to optimize performance of the products or process. Taguchi’s main purpose is to reduce the variability around the target value of product properties via a systematic application of statistical experimental design which called robust design. Robust Design is an important technique for product manufacturability and product life. Taguchi simplified the usage of orthogonal arrays to setup experimental design. Thanks to this development, researchers and engineers saved both time and money. Furthermore, Taguchi proposed the usage of S/N ratio in order to measure the effects of factors on the performance characteristics. In this study a brief knowledge about the Taguchi Method is given. Orthogonal Arrays and S/N ratios are described. Summary of a case study is given.

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Conference papers on the topic "Summary of Product Characteristics (SmPC)"

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Vuong, Tung Xuan, and Ahmed Al-Jumaily. "Computational Modeling and Analysis of Turbulent Flows in the Humidification Unit of the Continuous Positive Airways Pressure Device." In ASME 2021 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 2021. http://dx.doi.org/10.1115/imece2021-68573.

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Abstract In this paper, an investigation into the dynamics flow behaviour of a humidifier unit is carried out using the numerical simulation method. The Computational Aeroacoustics (CAA) with a hybrid approach is conducted in the ANSYS software environment. The CFD simulations were used to investigate the internal flow behaviours of the humification fluid model. The predicted results have shown the internal flow characteristics combined with scatters, circulations, and separation behaviours. These behaviours are due to the installation of a baffle unit inside the humification unit. Turbulent a

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Cheng, Ying, Fei Tao, Lin Zhang, and Dongming Zhao. "Dynamic Supply-Demand Matching for Manufacturing Resource Services in Service-Oriented Manufacturing Systems: A Hypernetwork-Based Solution Framework." In ASME 2015 International Manufacturing Science and Engineering Conference. American Society of Mechanical Engineers, 2015. http://dx.doi.org/10.1115/msec2015-9328.

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Nowadays, service-oriented manufacturing (SOM) systems (e.g., cloud manufacturing (CMfg), product service systems (PSS), etc.) have attracted more and more interesting and attention of researchers from many different fields. However, because of the complex and dynamic environment, one of the most important issues need to be addressed for the promotion and application of SOM system is the dynamic supply-demand matching and scheduling of manufacturing resource services. In this paper, the issue of supple-demand matching in the typical SOM system is carried out at first. Then the dynamics and dif

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Sakamoto, Haruo. "Fatigue and Fracture Mechanics in Products Development for Railroad Vehicles." In ASME 2007 International Mechanical Engineering Congress and Exposition. ASMEDC, 2007. http://dx.doi.org/10.1115/imece2007-41080.

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Railroad products suffer fatigue since they are used in a condition of cyclic loading when railroad vehicles run. Key products are the most important mechanical parts, which are wheels, axles, discs, and truck frames. They are such fail-out components, as can cause the fatal failure of vehicles, when the components fail. Among such components, wheels and axles are the most critical railroad components, since they can cause the derailment. Tremendous efforts to the research and development have been devoted in the area of railroad industry. However, the rail accident of German railroad in 1998

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Gopalakrishnan, Venkat, and Sridhar Kota. "A Parallely Actuated Work Support Module for Reconfigurable Machining Systems." In ASME 1998 Design Engineering Technical Conferences. American Society of Mechanical Engineers, 1998. http://dx.doi.org/10.1115/detc98/mech-5959.

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Abstract In order to respond quickly to changes in market demands and the resulting product design changes, machine tool manufacturers must reduce the machine tool design lead time and machine set-up time. Reconfigurable Machine Tools (RMTs), assembled from machine modules such as spindles, slides and worktables are designed to be easily reconfigured to accommodate new machining requirements. The essential characteristics of RMTs are modularity, flexibility, convertibility and cost effectiveness. The goal of Reconfigurable Machining Systems (RMSs), composed of RMTs and other types of machines,

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Vuong, Tung Xuan, Ahmed Al-Jumaily, and Robert Paxton. "Computational Analysis of the Dynamics Flow in the Duct System of an Continuous Positive Airways Pressure Device." In ASME 2020 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 2020. http://dx.doi.org/10.1115/imece2020-23333.

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Abstract In this paper, 3-D duct models of Continuous Positive Airway Pressure (CPAP) device are developed to investigate the internal airflow behaviours and to identify potential noise source locations. The Computational Aeroacoustics (CAA) with a hybrid approach is conducted in the ANSYS software environment. CFD simulations were used to investigate the internal flow behaviours of the duct systems. The predicted results have shown the internal flow characteristics as circulation and separation behaviours. Those behaviours were found at several locations such as 90-degree corners, restricted

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Gordon, J. L. "ADENINE NUCLEOTIDES AND THEREGULATION OF VASCULAR TONE." In XIth International Congress on Thrombosis and Haemostasis. Schattauer GmbH, 1987. http://dx.doi.org/10.1055/s-0038-1643719.

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ATP, although known mainly as an intracellular energy source, is also capable of acting extracellularly as a vasoactive agent of great potency, at concentrations around lμM or less. ADP is approximately equipotent with ATP in its actions on extracellular receptors in the vasculature.ATP and ADP can arise extracellularly through release from the cytoplasm of cellsexposed to damaging stimuli or by degranulation of platelets. The concentration of the nucleotides in the cytoplasm of most cells (including vascular endothelial and smooth muscle cells) is more than ImM, and the concentration in the d

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Lilly, Patrick, and George Simons. "California’s Self-Generation Incentive Program Nonresidential PV Systems: Measured System Performance and Actual Costs." In ASME 2006 Power Conference. ASMEDC, 2006. http://dx.doi.org/10.1115/power2006-88228.

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More than two hundred sixty grid-tied photovoltaic (PV) systems sized 30 kW to 1.1 MW installed in California during 2002 through 2004 received partial funding through the Self-Generation Incentive Program (SGIP). The SGIP is administered statewide by PG&E, SCE, SoCalGas, and the San Diego Regional Energy Office. The incentive is structured as a one-time capacity based payment made at the time of system completion. The first PV system incentive was paid in Summer 2002. Through the end of 2004, a total of 269 PV systems had received financial support through the program. The cumulative gene

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Hørte, Torfinn, Siril Okkenhaug, and Øivind Paulshus. "Mooring System Calibration of the Damaged Condition, Accidental Limit State (ALS)." In ASME 2017 36th International Conference on Ocean, Offshore and Arctic Engineering. American Society of Mechanical Engineers, 2017. http://dx.doi.org/10.1115/omae2017-61533.

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Structural reliability analysis (SRA) has been used to calculate the probability of two adjacent mooring line failures. The initial failure is caused by some exceptional causes which most likely is related to substandard strength, but could also be exceptionally high tension caused by mal operation. Empirical failure data are used to assess the probability of initial failure. The ALS in the context here should control the probability a second mooring line failure with ordinary strength, adjacent to the initial failure of a weak substandard line. This check is also called the ULS redundancy che

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