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Pharmacovigilance in Cell and Gene Therapy: Evolving Challenges in Risk Management and Long-Term Follow-Up.

Cell and gene therapies, including CAR T-cells, CRISPR-based genome editing, and next-generation viral and non-viral delivery platforms, are transforming treatment paradigms across cancer, rare genetic disorders, immune dysregulation, and neurodegenerative disease. These therapies offer curative potential but also present safety challenges owing to prolonged biological activity, systemic immune engagement, and lasting genomic alterations. This review examines the range of related toxicities, including immune complications, genotoxicity, and organ-specific effects, with attention to atypical pr

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… REMS programs may require prescriber certification and patient enrollment into registries, but systematic AE reporting is not always mandated unless specifically included under elements to assure safe use (ETASU) [ 123 ]. …

Nutritional vulnerability, food insecurity, and unmet supportive care needs in multiple myeloma: a cross-sectional study from China.

BACKGROUND: Multiple myeloma patients experience nutritional vulnerability through disease-related factors, treatment toxicity, and systemic inflammation, yet comprehensive assessment integrating validated nutrition screening with health equity dimensions remains limited. This study characterized nutritional vulnerability prevalence, determinants, and supportive-care access barriers among Chinese multiple myeloma patients. METHODS: This single-center, cross-sectional observational study conducted at Shanxi Provincial Key Laboratory, Taiyuan, China (January 2020-December 2024) employed compreh

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… Data collection procedures Data collection occurred during a single comprehensive assessment visit (approximately 45–60 min) conducted by trained research nurses and a registered dietitian with specialized oncology nutrition certification. …

Current Landscape and Future Directions in Cancer Immunotherapy: Therapies, Trials, and Challenges.

Cancer remains a leading global health challenge, placing immense burdens on individuals and healthcare systems. Despite advancements in traditional treatments, significant limitations persist, including treatment resistance, severe side effects, and disease recurrence. Immunotherapy has emerged as a promising alternative, leveraging the immune system to target and eliminate tumour cells. However, challenges such as immunotherapy resistance, patient response variability, and the need for improved biomarkers limit its widespread success. This review provides a comprehensive analysis of the curr

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… After successful Phase III trials, it achieved GMP certification in 2006, paving the way for the commercial production of this pioneering oncolytic virus product [ 134 , 135 ]. …

Current and future applications of ultrasound imaging in peripheral nerve disorders.

Neuromuscular ultrasound (NMUS) is a rapidly evolving technique used in neuromuscular medicine to provide complimentary information to standard electrodiagnostic studies. NMUS provides a dynamic, real time assessment of anatomy which can alter both diagnostic and management pathways in peripheral nerve disorders. This review describes the current and future techniques used in NMUS and details the applications and developments in the diagnosis and monitoring of compressive, hereditary, immune-mediated and axonal peripheral nerve disorders, and motor neuron diseases. Technological advances have

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… However, standardisation, assessment and accreditation processes should also be developed to provide certification for both supervisors and training sites. …

A Comprehensive Evaluation of CAR-T Cell Gene Therapy, Tracing its Revolutionary Clinical Breakthroughs and Advancements Towards Next-Generation Engineering.

BACKGROUND: CAR-T cell gene therapy has advanced from an experimental concept to a standard curative treatment for selected hematologic malignancies. Substantial clinical evidence has established CAR-T therapy as a cornerstone for relapsed/refractory B-cell malignancies and multiple myeloma, demonstrating durable, long-term remissions. In 2025, the U.S. Food and Drug Administration (FDA) eliminated the Risk Evaluation and Mitigation Strategy (REMS) requirement, reflecting improved clinical management of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome

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… The REMS programme, defined by its strict requirements for site certification and monitoring, was a cornerstone of early adoption but was discontinued following the determination that these specific mandates had become obsolete. …

Sending the Signal to Bone: How Tumor-Derived EVs Orchestrate Pre-Metastatic Niche Formation and Skeletal Colonization.

Bone is a preferred site for disseminated tumor cells, yet the molecular mechanisms that prepare the skeletal microenvironment for metastatic colonization are only beginning to be understood. At the heart of this process are extracellular vesicles (EVs), nano-sized, lipid-encapsulated particles secreted by cancer cells and stromal components. This review consolidates current findings that position EVs as key architects of the bone-metastatic niche. We detail the biogenesis of EVs and their organotropic distribution, focusing on how integrin patterns and bone-specific ligands guide vesicle homi

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… As exRNA diagnostic platforms become available, there will be requirements for clinical certification and manufacturing standards development. Furthermore, pressure will emerge to define and centralize biofluids from normative biological controls [ 247 ]. …

Global, regional, and national disability-adjusted life-years (DALYs) for 315 diseases and injuries and healthy life expectancy (HALE), 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015.

BACKGROUND: Healthy life expectancy (HALE) and disability-adjusted life-years (DALYs) provide summary measures of health across geographies and time that can inform assessments of epidemiological patterns and health system performance, help to prioritise investments in research and development, and monitor progress toward the Sustainable Development Goals (SDGs). We aimed to provide updated HALE and DALYs for geographies worldwide and evaluate how disease burden changes with development. METHODS: We used results from the Global Burden of Diseases, Injuries, and Risk Factors Study 2015 (GBD 20

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… health outcomes. 20 Estimation of mortality and non-fatal health loss We estimated all-cause and cause-specific mortality with a multistep computation process, which included systematically addressing known data challenges, such as different coding schemes, different age-group reporting, variation in certification …

ESMO / ASCO Recommendations for a Global Curriculum in Medical Oncology Edition 2016.

The European Society for Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO) are publishing a new edition of the ESMO/ASCO Global Curriculum (GC) thanks to contribution of 64 ESMO-appointed and 32 ASCO-appointed authors. First published in 2004 and updated in 2010, the GC edition 2016 answers to the need for updated recommendations for the training of physicians in medical oncology by defining the standard to be fulfilled to qualify as medical oncologists. At times of internationalisation of healthcare and increased mobility of patients and physicians, the GC aims to p

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… encouraged to participate in the educational activities of professional organisations, community programmes and institutional committees. 3.3.3 Responsibility Lines of responsibility must be clearly delineated for the trainees in medical oncology. 3.3.4 Update of skills and knowledge Having obtained certification … on general management strategies in the neoadjuvant and the adjuvant setting, as well as at advanced stage References European Society of Surgical Oncology Core Curriculum, 2010. http://www.essoweb.org/eursso/education/core-curriculum.html Michelassi F. 2010 SSO presidential address: subspecialty certificate …

Abstracts of the 12th European Cytogenomics Conference 2019 : Salzburg, Austria. 6-9 July 2019

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… 17:15-17:30 Selected Abstract Fengtang Yang: Characterisation of complex genomic structure and variation by high-resolution fibre-FISH: an overview Concurrent Session 8 - Accreditation, quality control and education Chairs: Konstantin Miller - Albert Schinzel 16:15-16:45 Thomas Liehr: European Certification … 17:15-17:30 | Selected Abstract Fengtang Yang: Characterisation of complex genomic structure and variation by high-resolution fibre-FISH: an overview Concurrent Session 8 - Accreditation, quality control and education Chairs: Konstantin Miller - Albert Schinzel 16:15-16:45 | Thomas Liehr: European Certification …

Abstracts of the 36th Annual Meeting of the Society of General Internal Medicine. April 24-27, 2013. Denver, Colorado, USA.

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… METHODS: In this randomized controlled trial diplomates who are primary care providers for patients over age 50 and who were enrolled in ABIM’s Maintenance of Certification program were invited to participate. … METHODS: We studied internists enrolled in the ABIM Maintenance of Certification (MOC) program who registered for and entered at least one question in the ABIM Point-of-Care Clinical Question Module between November 2010 and December 2012. …

2022 International Cancer Education Conference Late-Breaking Abstracts

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… Purpose/Methods: We developed the Pathways to Cancer Prevention certification, a 16-hour training to certify CHWs to provide cancer screening referrals (breast, colorectal, lung, prostate, and cervical cancers) and cancer prevention education for underserved communities to mitigate declines in screening …

Endothelial dysfunction in congenital adrenal hyperplasia due to 21-hydroxylase deficiency: current knowledge and novel biomarkers.

Congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21OHD) is a complex endocrine disorder characterized by impaired cortisol synthesis and androgen excess. Beyond its hormonal and metabolic implications, CAH has been increasingly associated with an elevated risk of cardiovascular complications, including endothelial dysfunction, a critical precursor to atherosclerosis and a risk factor for cardiovascular and metabolic diseases. This review explores the current knowledge on endothelial function in patients with CAH, focusing on the interplay between chronic hormonal imbalanc

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… PAT operators can be trained in a relatively short amount of time and do not require specialized certification. A major limitation is the unclear understanding of its pathophysiological basis ( 100 ). Unlike FMD, which evaluates macrovascular dilation, PAT assesses microvessel dilation. …

ESMO/ASCO Recommendations for a Global Curriculum in Medical Oncology Edition 2023.

The European Society for Medical Oncology (ESMO) and ASCO are publishing a new edition of the ESMO/ASCO Global Curriculum (GC) with contributions from more than 150 authors. The purpose of the GC is to provide recommendations for the training of physicians in medical oncology and to establish a set of educational standards for trainees to qualify as medical oncologists. This edition builds on prior ones in 2004, 2010, and 2016 and incorporates scientific advances and input from an ESMO/ASCO survey on GC adoption conducted in 2019, which revealed that GC has been adopted or adapted in as many a

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… Update of Skills and Knowledge Having obtained certification in medical oncology, the specialist is expected to update the acquired skills and knowledge by participating in continuing medical education programmes such as courses, symposia, or self-learning processes on a regular basis. … Eur J Surg Oncol 42:754-766, 2016 Michelassi F: 2010 SSO presidential address: Subspecialty certificate in advanced surgical oncology. Ann Surg Oncol 17:3094-3103, 2010 Are C, Caniglia A, Malik M, et al: Variations in training of surgical oncologists: Proposal for a global curriculum. …

A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy.

This review explores the transformative role of three-dimensional (3D) printing in radiation therapy for cancer treatment, emphasizing its potential to deliver patient-specific, cost-effective, and sustainable medical devices. The integration of 3D printing enables rapid fabrication of customized boluses, compensators, immobilization devices, and GRID collimators tailored to individual anatomical and clinical requirements. Comparative analysis reveals that additive manufacturing surpasses conventional machining in design flexibility, lead time reduction, and material efficiency, while offering

Catching Them Early: Framework Parameters and Progress for Prenatal and Childhood Application of Advanced Therapies.

Advanced therapy medicinal products (ATMPs) are medicines for human use based on genes, cells or tissue engineering. After clear successes in adults, the nascent technology now sees increasing pediatric application. For many still untreatable disorders with pre- or perinatal onset, timely intervention is simply indispensable; thus, prenatal and pediatric applications of ATMPs hold great promise for curative treatments. Moreover, for most inherited disorders, early ATMP application may substantially improve efficiency, economy and accessibility compared with application in adults. Vindicating t

Неделя ГЭЭ 2017 Презентации на плакате

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ESMO/ASCO Recommendations for a Global Curriculum in Medical Oncology Edition 2023.

The European Society for Medical Oncology (ESMO) and ASCO are publishing a new edition of the ESMO/ASCO Global Curriculum (GC) with contributions from more than 150 authors. The purpose of the GC is to provide recommendations for the training of physicians in medical oncology and to establish a set of educational standards for trainees to qualify as medical oncologists. This edition builds on prior ones in 2004, 2010, and 2016 and incorporates scientific advances and input from an ESMO ASCO survey on GC adoption conducted in 2019, which revealed that GC has been adopted or adapted in as many a

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… This encourages the transition from an early to an advanced learner. 3.3.4 Update of Skills and Knowledge Having obtained certification in medical oncology, the specialist is expected to update the acquired skills and knowledge by participating in continuing medical education programmes such as courses …

2026 Приложение к резюме Международного конгресса

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Companion Diagnostics in Clinical Therapy: Current Applications and Future Directions.

Companion diagnostics (CDx) plays a pivotal role in precision medicine by enabling personalized treatment plans based on individual biomarker profiles. This approach can enhance therapeutic efficacy in selected indications and may reduce healthcare expenditures. Particularly in oncology, precision targeted therapies targeting pathways such as EGFR, HER2, and programmed death-1/programmed death-ligand 1 have established robust models for biomarker-driven treatment. However, rapid advancements in diagnostic technologies, expanding application scopes, and increasingly complex mechanisms of biomar

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… In contrast, within the EU, a drug may obtain formal approval from the EMA, while the diagnostic test often qualifies for manufacturer self‐certification under the EU IVD directive [ 52 ]. …

From laboratory to clinic: opportunities and challenges of functional food active ingredients in cancer therapy.

This review provides a comprehensive analysis of the potential of functional food active ingredients in cancer prevention and therapy. It outlines the multifaceted anticancer mechanisms of bioactive compounds-such as polyphenols, carotenoids, omega-3 fatty acids, phytosterols, alkaloids, isothiocyanates, polysaccharides, phenolic acids, flavonols, and amide-bearing compounds-which include antioxidant and anti-inflammatory activities, induction of apoptosis and autophagy, modulation of the tumor microenvironment, interference with cell cycle regulation and signaling pathways, and regulation of