“…The African Vaccines Regulatory Forum, African Medicines Regulatory Harmonization Initiative, Network of Official Medicines Control Laboratories and WHO Prequalification Scheme have helped countries strengthen their regulatory capacities. …”
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“…While general objectives for postgraduate training programs have not been very clear, only recently competency-frameworks, created in a limited number of countries, serve harmonize objectives. This process appears to be a challenge and the recent creation of milestones for the reporting on progress of individual trainees (in the US and in Canada in different ways) and the adoption of entrustable professional activities, a most recent concept that is quickly spreading internationally as a framework for teaching and assessing in the clinical workplace is an interesting and hopeful development, but time will tell whether true harmonization across countries will happen.…”
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“…The lithium disilicate veneers were able to provide the harmonization of the patient's smile, recovering the teeth size, shape, and anatomic characteristics.…”
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“…Leflunomide (LLM) is subjected to forced degradation under conditions of hydrolysis, oxidation, dry heat, and photolysis as recommended by International Conference on Harmonization guideline Q1A(R2). In total, four degradation products (I–IV) were formed under different conditions. …”
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“…METHODS: The Portuguese-language version was developed according to a rigorous methodology, which included the following steps: preparation; translation from English into Portuguese in three versions; reconciliation to a single version; back-translation of that version into English; comparison and harmonization of the back-translation with the original version; review of the Portuguese-language version; cognitive debriefing; text review; and arrival at the final version. …”
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“…In the first round of answers, it was observed that 20% had difficulty in understanding the expression “joint awareness.” In further harmonization of the questionnaire, it was decided to change the term “awareness” for “remember.” …”
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“…Use of Quantitative Structure-Activity Relationships ((Q)SAR) prediction tools has been increasing since the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) M7 guideline was issued in June 2014. …”
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“…Much has been achieved within the respective European organizations in the development of curricula that will harmonize the postgraduate training at least within the European Union (EU). …”
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“…Conclusively, the legal frameworks require reformation and harmonization for the collective benefit to employees, employers, and regulatory authorities. …”
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“…EQA-PT schemes are of primordial importance to the analytical quality, standardization of methods and harmonization of the results. Laboratories are familiar with EQA-PT schemes as they are a prerequisite for their accreditation according to the ISO/IEC 15189 standard. …”
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“…Since clinical failures of polymorph drugs have not been uncommon, and some of them have been entirely unexpected, the Food and Drug Administration (FDA) and the International Conference on Harmonization (ICH) has required preliminary and exhaustive screening studies to identify and characterize all the polymorph crystal forms for each drug. …”
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“…Since a standardized dietary assessment method in health counseling might be desirable for the harmonization of work with diseases prevention in an occupational field, findings in this study could propose appropriate targets to reduce confusion in health professionals’ concerning the use of validated questionnaires.…”
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“…The need for country-specific requirements and harmonization of methodologies related to nutrient requirements and RDA are also discussed. …”
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“…These changes also render this phantom data more suitable for inter‐PET‐scanner harmonization and improve its utility for comparing image reconstruction methods.…”
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“…Emerging market regulators are also focusing on simplifying their regulatory pathways via regional harmonization schemes with varying levels of ambition. …”
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“…These challenges and the impact on food composition data for the Mediterranean region were reviewed during the NUTRIMAD 2018 congress of the Spanish Society for Community Nutrition. Data harmonization and standardization, data compilation and use, thesauri, food classification and description, and data exchange are some of the areas that require new approaches. …”
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“…However, there is still difficulty related to these sensors meeting specific needs and challenges such as those of cultural heritage and supporting archaeological research world-wide. The harmonization and synergistic use of different sensors can be used in order to maximize the impact of earth observation sensors and enhance their benefit to the scientific community. …”
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“…On April 2018 an online survey was sent to all RITA members in order to facilitate the harmonization of data collection in rare immune disorders registries. …”
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“…The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has published guidance documents on the requirements for such validation activities and these have been adopted by the European Medicines Agency, The U.S. …”
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“…In addition to development and improvement of methods for the study of hemolysis, it is necessary to carry out comparative studies to determine which one offers the best capabilities. Harmonization of the methods will allow to include them in working guidelines. …”
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