Expediting Innovation in Singapore with Regulatory Knowledge

2013 ◽  
pp. 233-242 ◽  
Keyword(s):  
Regulatory Knowledge

scholarly journals Pengaruh Pengetahuan Peraturan, Komitmen Manajemen, Dan Lingkungan Birokrasi Terhadap Penyerapan Anggaran Terkait Pengadaan Barang/Jasa

2020 ◽  
Vol 2 (4) ◽  
pp. 3705-3719
Author(s):  
Muhammad Ikhsan ◽  
Vita Fitria Sari
Keyword(s):  
Knowledge Management ◽  
Multiple Regression ◽  
Sampling Technique ◽  
Procurement Management ◽  
Management Commitment ◽  
The Government ◽  
Regulatory Knowledge

This study aims to determine the effect of regulatory knowledge, management commitment, and the bureaucratic environment on budget absorption related to the procurement of goods / services in the government of Padang City. A sample of 82 respondents was determined by using a total sampling technique consisting of heads of fields or staff of the procurement department. Data were analyzed using multiple regression formulas with the help of the SPSS application. This study concludes that regulatory knowledge does not affect budget absorption related to goods / services procurement. Management commitment has a positive and significant effect on budget absorption related to the procurement of goods / services. Meanwhile, the bureaucratic environment has no effect on budget absorption related to the procurement of goods / services

scholarly journals Rotulagem de medicamentos industrializados: uma análise das diretrizes legais brasileiras e contribuições para a qualidade de produtos

2020 ◽  
Vol 20 (81) ◽  
Author(s):  
Márcia Lombardo
Keyword(s):  
Drug Product ◽  
Regulatory Agencies ◽  
Quality And Safety ◽  
Sources Of Information ◽  
Normative Documents ◽  
Drug Products ◽  
Legal Provisions ◽  
Product Surveillance ◽  
Study Results ◽  
Regulatory Knowledge

RESUMOObjetivos: a rotulagem é um aspecto de qualidade fundamental no uso de medicamentos, seja pelo profissional de saúde, seja pelo paciente. Este trabalho propôs uma análise crítica do tema com base na legislação em vigor, bem como a triagem de documentos normativos úteis no processo de elaboração ou de avaliação da conformidade da rotulagem de medicamentos. Métodos: foi realizada uma pesquisa documental empregando-se como fonte de informações os sítios eletrônicos oficiais do Ministério da Saúde e da Agência Nacional de Vigilância Sanitária. Os documentos contendo itens pertinentes a rotulagem de medicamentos e classificados como vigentes ou vigentes com alteração foram selecionados para a realização do estudo. Resultados: os quesitos mais relevantes das disposições gerais e das disposições específicas da norma vigente para rotulagem de medicamentos foram sistematizados, verificando-se suas contribuições na qualidade e segurança de produtos. Embora a padronização da rotulagem de medicamentos seja necessária, a ocorrência de elevados graus de semelhança entre rótulos, embalagens ou mesmo nomenclaturas é discutida no âmbito da prática clínica e esta questão merece atenção especial. A busca de material complementar à legislação vigente resultou no levantamento de um total de 20 documentos, incluindo normas, guias, bancos de consulta e planilhas, que podem auxiliar no cumprimento dos requisitos de rotulagem de medicamentos. Conclusão: rótulos de medicamentos são recursos técnicos que contribuem na eficácia e na segurança do tratamento. Os esforços das Agências Reguladoras têm permitido a consolidação de diretrizes legais para que informações e formatos adequados de rotulagem sejam aplicados nas embalagens de medicamentos industrializados. A elaboração ou a análise da rotulagem de medicamentos requer amplo conhecimento regulatório, o qual é dinâmico e, portanto, um grande desafio.Palavras-chave: Rotulagem de Medicamentos. Legislação de Medicamentos. Vigilância de Produtos Comercializados. Segurança do Paciente. ABSTRACTObjectives: the labeling of drug products is an aspect of quality that is fundamental to the use of medicines, whether by the health professional or by the patient. This work proposed a critical analysis of the current legislation on the labeling of drug products, as well as the screening of normative documents useful for the process of preparing or assessing the conformity of labels. Methods: a documentary research was carried out using the official websites of the Ministry of Health and the National Health Surveillance Agency (Brazil) as sources of information. The documents containing relevant items on labeling of drug products and classified as current or current with changes were selected for the study. Results: the most important requirements of the general and specific provisions from the current legislation have been systematized, and their contributions to the quality and safety of products have been verified. Although the standardization of the labeling is necessary, the occurrence of high degrees of similarity between labels, packaging or even nomenclatures is discussed in the context of clinical practice and this issue deserves special attention. The search for material complementary to the current legislation resulted in the collection of a total of 20 documents, including normative documents, guides, databases and spreadsheets, which might help in complying with the requirements for the labeling of drug products. Conclusion: the labeling of drug products are technical resources that contribute to the effectiveness and safety of treatment. The efforts of the Regulatory Agencies have allowed the consolidation of legal provisions for the dissemination of appropriate information and labeling formats in the packaging of drug products. The drafting or analysis of the labels requires extensive regulatory knowledge, which is dynamic and, therefore, a great challenge.Keywords: Drug Labeling. Legislation, Drug. Product Surveillance, Postmarketing. Patient Safety.

scholarly journals Predicting miRNA Targets by Integrating Gene Regulatory Knowledge with Expression Profiles

PLoS ONE ◽  
2016 ◽  
Vol 11 (4) ◽  
pp. e0152860 ◽  
Author(s):  
Weijia Zhang ◽  
Thuc Duy Le ◽  
Lin Liu ◽  
Zhi-Hua Zhou ◽  
Jiuyong Li
Keyword(s):  
Expression Profiles ◽  
Mirna Targets ◽  
Gene Regulatory ◽  
Regulatory Knowledge

scholarly journals Regulatory Support Improves Subsequent IRB Approval Rates in Studies Initially Deemed Not Ready for Review: A CTSA Institution’s Experience

2018 ◽  
Vol 13 (2) ◽  
pp. 139-144
Author(s):  
Susan Sonne ◽  
Stephanie Gentilin ◽  
Royce R. Sampson ◽  
Leslie Bell ◽  
Toni Mauney ◽  
...  
Keyword(s):  
Junior Faculty ◽  
Support Service ◽  
Institutional Review Board ◽  
Translational Science ◽  
Research Teams ◽  
Institutional Review ◽  
Medical University ◽  
The Impact ◽  
Regulatory Knowledge

We evaluated the impact of a regulatory support service (known as the Regulatory Knowledge and Support [RKS] program), part of the Medical University of South Carolina’s Clinical and Translational Science Award, on the success of Institutional Review Board (IRB) applications that have previously been deemed by the IRB to be Not Ready for Review (NRR). At the time of this evaluation, 77 studies had been deemed NRR, 53 of which came from trainees and junior faculty. All the applications that received regulatory support either received IRB approval or were deemed to not be research, and therefore did not require IRB review. In all, 39.1% (n = 18) of the research teams who did not accept regulatory support successfully received IRB approval. Providing regulatory support, particularly to trainees and junior faculty, may be associated with better success in obtaining IRB approval as well as preventing the unnecessary submission of projects that are not research and would therefore not require IRB review or approval.

scholarly journals ‘New Drugs’ Approvals in India: An Institutional Perspective

2018 ◽  
Vol 23 (3) ◽  
pp. 444-462 ◽  
Author(s):  
Saradindu Bhaduri ◽  
Thangminlen Kipgen
Keyword(s):  
New Drugs ◽  
Decision Making Process ◽  
Institutional Perspective ◽  
The Public ◽  
Institutional Settings ◽  
Regulatory Processes ◽  
Catch Up ◽  
The Public Sphere ◽  
Context Specific ◽  
Regulatory Knowledge

The approval mechanism for new drugs in India has in recent years been a subject of scrutiny and controversy in both the public sphere and academics. Frequent rollbacks in the guidelines have attracted criticisms from the industry as well. All this happens at a time, when the country aspires to catch up and keep pace with the fast-changing global regulatory norms. This article draws upon the scholarships on regulatory science and institutional theories to understand the regulatory processes of new drugs approval in India. Both strands of scholarships highlight the multidisciplinary, context-specific character of regulatory knowledge. We find that Indian regulation-making process relies heavily on regulatory knowledge built up elsewhere, potentially limiting the scope of generating its own, context-specific, regulatory knowledge through learning and capacity building. Inadequate level of deliberations in the decision-making process, dearth of documentation and a lack of connections with the larger institutional settings appear to be two other features of it. All this might explain the reasons for frequent changes, and lack of continuity, in regulation for new drugs approval in the country in recent years.

New Transnational Governance and the Changing Composition of Regulatory Pluralism in Southeast Asia

2014 ◽  
Vol 9 ◽  
pp. 65-95 ◽  
Author(s):  
John Gillespie
Keyword(s):  
Southeast Asia ◽  
Transnational Governance ◽  
Wealth Creation ◽  
Law And Development ◽  
Ethnographic Studies ◽  
Legal Literature ◽  
Slow Progress ◽  
Northeast Asian ◽  
Business Sectors ◽  
Regulatory Knowledge

AbstractOver the past three decades, Transnational Production Regimes (TPRs) have become the main source of technical and regulatory knowledge for Southeast Asia corporations. Typically TPRs transfer knowledge from lead firms located in the industrial North to supplier firms located in Southeast Asia. Regulatory knowledge transferred through TPRs largely bypasses Southeast Asian laws and legal institutions to directly influence the behavior of supplier firms. Although socio-economic studies show that TPRs are responsible for generating much wealth creation in the region, they hardly register in the socio-legal literature. Drawing on ethnographic studies conducted in Vietnam, this paper will attempt to explain why different types of TPRs produce different regulatory responses in Vietnamese firms. Preliminary findings suggest differences in the way that regulatory knowledge transmitted through Northeast Asian and Euro-American TPRs is absorbed and integrated into the organisational fabric of Vietnamese firms. They also shed light on two well-documented phenomena in Vietnam. In conclusion the paper will argue that TPRs displace state commercial laws and are partially responsible for the slow progress of conventional law and development projects in changing regulatory practices. It will contend that the different kinds of TPRs generate regulatory pluralism and the uneven application of state law in different business sectors.

Innovation networks in the German energy industry

2017 ◽  
Vol 11 (2) ◽  
pp. 268-294 ◽  
Author(s):  
Michael Kolloch ◽  
Fabian Reck
Keyword(s):  
Knowledge Transfer ◽  
Knowledge Exchange ◽  
Energy Industry ◽  
Innovation Networks ◽  
Firm Level ◽  
Content Type ◽  
External Knowledge ◽  
Types Of Knowledge ◽  
Different Types ◽  
Regulatory Knowledge

Purpose This paper aims to focus on how different types of knowledge are exchanged within innovation networks in the German energy industry. External factors such as market pressure through liberalization, de-carbonization and decentralization challenge established actors in the industry. Answers to these challenges cannot be found by single actors but require networks to gather and concentrate innovation activities. This implies a need for knowledge transfer among energy providers. The authors aim at exploring knowledge exchange relations in-depth by treating them as multidimensional flows which can comprise technological, market, managerial or regulatory knowledge. In detail, the authors examine patterns of knowledge exchange on network-, dyad- and firm-level. Furthermore, first, empiric results are provided on how two of these patterns, namely, a firm’s propensity to form multiplex instead of uniplex ties as well as the composition of externally acquired knowledge concerning the four types, influence organizational innovativeness. Design/methodology/approach The authors address their research questions by conducting an in-depth investigation of the largest network of municipal utilities in Germany. The analysis is based on quantitative data collected via standardized online questionnaires drawing on socio-metric methods to reconstruct knowledge exchange networks as well as traditional approaches from socio-empiric research to evaluate firm innovativeness. Findings The findings indicate that while technological, market, managerial and regulatory knowledge represent different types of knowledge with different exchange patterns, these transfers are interdependent. In particular, the analysis reveals non-hierarchical relations of complementarity. The authors furthermore provide evidence for the existence of ideal profiles for attaining different types of innovation. One central tendency across all of these profiles is that outperformers acquire regulatory knowledge to a significantly lesser degree than other firms and focus more on the other types instead. Research limitations/implications This paper solely focusses on the largest network of municipal utilities whereby it is questionable how representative it is for the whole industry. Additionally, due to the cross-sectional design, the paper cannot fully rule out issues of endogeneity in the quantitative analysis. Practical implications This paper delivers valuable insights for managers in the energy sector who seek to either enter and manage inter-organizational networks or apply external knowledge to foster innovation. In particular, the authors reveal benchmark profiles for external knowledge acquisition which may serve as templates for strategic collaboration and innovation management. Originality/value To the authors’ knowledge, this paper presents the first innovation-related network analysis in the energy industry. Rather than operationalizing knowledge transfer as a simplex flow relation, the authors examine different types of knowledge, their patterns of exchange and their distinct effects on process, product and administrative innovations.

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