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  • 1
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    IJDRA Publishing group
    Online: 1(1).2013 –
    Publisher: IJDRA Publishing group
    Electronic ISSN: 2321-6794
    Topics: Chemistry and Pharmacology
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  • 2
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    New Delhi: Indian Council for Research on International Economic Relations (ICRIER)
    Publication Date: 2018-03-22
    Description: Drug Regulation has been the focus of several recent policy reform efforts in India, starting with the Mashelkar Committee Report in 2003 to the most recent report of the Ranjit Roy Chaudhary Committee in 2013. Nevertheless, the regulatory structure continues to be plagued with several structural challenges, including issues related to regulatory harmonisation between the centre and the states, access to regulatory resources, transparency, which have undermined the general effectiveness of the regulatory system. At the juncture when the Drugs and Cosmetics (Amendment) Bill, 2015 to amend the Drugs and Cosmetic Act, 1940, is expected to overhaul the drug regulation, this study, the first of its kind, evaluates the administrative structure and functions of drug regulatory authorities at both the federal and state level along with comparative perspectives on similar challenges from other international jurisdictions. Through legal and policy analysis, supported by stakeholder interactions, this study not only provides a systematic analysis of the current challenges, along with actionable policy recommendations and suggests possible means for their operationalisation.
    Keywords: I18 ; K32 ; K42 ; ddc:330 ; Government Policy ; Regulation ; Public Health ; Environmental ; Health ; Safety Law ; Illegal Behaviour and the Enforcement of Law
    Repository Name: EconStor: OA server of the German National Library of Economics - Leibniz Information Centre for Economics
    Language: English
    Type: doc-type:workingPaper
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  • 3
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    Köln: Max-Planck-Institut für Gesellschaftsforschung
    Publication Date: 2016-11-30
    Description: The EC harmonized market entry regulation for pharmaceuticals from the early sixties on, but it achieved neither its goal of uniform national regulatory decisions nor that of automatic mutual recognition. Subsequent attempts to Europeanize the procedures themselves resulted in two alternatives in 1995: a Centralized Procedure for innovative pharmaceutical products implemented at the EU level, and a Decentralized Procedure which tries to assure mutual recognition. First, the paper analyzes the distinctive modes of Europeanization employed in these regulatory alternatives, examining both their impact on the effectiveness of European governing and the balance they strike between European interventionism, national participation and national autonomy. Second, it tries to assess whether Europeanization furthers the goals of pharmaceutical market entry policy as defined in European regulations - public health protection, creation of a single market and the reduction of regulatory costs to industry. There is little evidence that the public's health is less well protected when regulation is Europeanized. Only the Centralized Procedure contributes significantly to the goal of establishing a single market. Regulatory costs in terms of approval time did go down especially for pharmaceutical firms using the Centralized Procedure, mainly because of efficiency-enhancing legal provisions and institutionally induced regulatory competition between national authorities.
    Description: Seit Anfang der sechziger Jahre hat die EG das Zulassungsrecht für Arzneimittel harmonisiert, ohne damit das Ziel uniformer nationaler Zulassungsentscheidungen bzw. die gegenseitige Anerkennung derselben zu erreichen. In einer zweiten Stufe kam es zu Versuchen, die Verfahren selbst zu europäisieren, was 1995 in die Einführung von zwei europäischen Zulassungsverfahren mündete - eines zentralisierten mit europäischer Implementationsstruktur für innovative Medikamente und eines dezentralen, das die gegenseitige Anerkennung nationaler Entscheidungen prozedural durchsetzen soll. In diesem Papier werden zunächst die in diesen Verfahren verwirklichten Formvarianten regulativer Europäisierung und das je charakteristische Verhältnis zwischen europäischer Intervention, nationaler Partizipation und nationaler Autonomie analysiert sowie nach der Effektivität europäischen Regierens gefragt. In einem weiteren Schritt wird abzuschätzen versucht, wie sich diese Europäisierungsstrategien auf die in der europäischen Regulierung verankerten Ziele des öffentlichen Gesundheitsschutzes, der Binnenmarktetablierung und der Industrieförderung auswirken. Es spricht wenig dafür, dass die Europäisierung des Zulassungsverfahrens den Gesundheitsschutz systematisch vernachlässigt. Zur Verwirklichung des Binnenmarkts bei Arzneimitteln trägt bislang eindeutig nur das zentralisierte Verfahren bei. Schließlich: Insbesondere durch rechtliche Vorgaben und einen institutionell induzierten regulativen Wettbewerb zwischen nationalen Behörden wurden die regulativen Kosten - gemessen in Zulassungszeiten - speziell für die Unternehmen reduziert, die das zentralisierte Verfahren nutzen können.
    Keywords: ddc:330 ; Arzneimittelrecht ; EU-Recht ; Gesundheitspolitik ; EU-Binnenmarkt ; EU-Staaten
    Repository Name: EconStor: OA server of the German National Library of Economics - Leibniz Information Centre for Economics
    Language: English
    Type: doc-type:workingPaper
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  • 4
    Publication Date: 2018-12-07
    Description: This study provides an overview of policy measures targeting pharmaceutical expenditure in Europe and analyses their impact on originator pharmaceutical prices. Panel data methods are used to examine the market of ACE Inhibitors in six European countries (Denmark, France, Germany, Netherlands, Sweden, United Kingdom) over period 1991-2006. We find that although some measures are effective in reducing originator prices, others appear to have an insignificant effect. Results suggest that supply side measures such as mandatory generic substitution, regressive pharmacy mark-ups and claw-backs are effective in reducing pharmaceuticals prices. Results are not as strong for demand side measures. Profit controls and the use of cost-effectiveness analysis appear to have a negative effect on prices, while results on reference pricing are inconclusive. Findings also indicate that, although originator prices are not immediately affected by generic entry, they may be influenced by changes in generic prices post patent expiry.
    Keywords: ddc:330 ; regulation ; pharmaceuticals ; panel data ; Europe ; Pharmazeutisches Produkt ; Preisregulierung ; Gesundheitskosten ; Europa
    Repository Name: EconStor: OA server of the German National Library of Economics - Leibniz Information Centre for Economics
    Language: English
    Type: doc-type:article
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  • 5
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    Warsaw: Center for Social and Economic Research (CASE)
    Publication Date: 2016-02-20
    Description: This working document offers a conceptual framework for understanding the processes underpinning the external dimension of EU Justice and Home Affairs (ED-JHA). Practically, it defines how the export of JHA principles and norms inform the geopolitical ambitions of the EU, i.e. the use of space for political purposes, or the control and management of people, objects and movement. The author begins by investigating how the ENP reconfigures the ED-JHA, and then goes on to discuss various conceptual stances on governance, specifically institutionalism, constructivism, and policy instruments. To conclude he traces the evolution of this external dimension, emphasising, whenever possible, its continuities and bifurcations. Overall, the aim is to ascertain the extent to which conceptual designs clarify or advance our knowledge of the contents and rationales of the ED-JHA.
    Keywords: ddc:330 ; neighbourhood policy ; international politics ; geopolitics ; migration ; immigration ; European security ; policy instruments ; governance ; Security and Justice ; Justice and Home Affairs ; EU-Politik ; EU-Nachbarstaaten ; Öffentliche Sicherheit ; EU-Staaten
    Repository Name: EconStor: OA server of the German National Library of Economics - Leibniz Information Centre for Economics
    Language: English
    Type: doc-type:report
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  • 6
    Publication Date: 2018-06-26
    Keywords: ddc:330
    Repository Name: EconStor: OA server of the German National Library of Economics - Leibniz Information Centre for Economics
    Language: English
    Type: doc-type:report
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  • 7
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    Makati City: Philippine Institute for Development Studies (PIDS)
    Publication Date: 2018-02-02
    Description: The Philippine fishing industry is considered as one of the major industries in the agriculture and fisheries sector. The marine resources available to the country indicate its vast potential in employment creation and output growth. It is in this light that the research team conducted this study with special focus on the tuna industry. The study objectives are to (a) provide regulatory mapping imposed on the local tuna industry; (b) identify those regulations considered as unnecessary or too burdensome to the industry; and (c) provide some recommendations on removing unnecessary regulations. An important inclusion in this project is the Informed Regulatory Conversation which allows the regulators and the private sector to discuss the identified issues and come up with unified recommendations to ease the regulatory burden on different tuna industry stakeholders. The result of the regulatory mapping shows the extent and number of regulations affecting the industry. Overall, the regulations imposed on the industry, especially those concerned with food safety standards, make sense and are necessary. However, there is a case for improving the regulatory framework of the tuna industry, especially the procedures for registration, licensing, and inspection as discussed in detail in the report. The regulatory issues that were identified by the team basically focused on a) acquiring business permit; b) acquiring registration and licenses for all types of fishing vessels from MARINA, BFAR, and the local government unit; c) acquiring License to Operate from the FDA and the possible case of duplication of inspection process by the BFAR and FDA; d) acquiring Certificate of Product Registration from the FDA; e) the Qualified Person in Industry Regulatory Affairs of FDA; and f) presence of BFAR signatories for the regulatory instruments, among others. Agreements to solve the regulatory burden to address the issues are detailed in the report.
    Keywords: ddc:330 ; regulatory impact analysis ; regulatory burden ; regulations ; cost of doing business ; tuna industry ; Hazard Analysis of Critical Control Points ; license to operate ; business permit
    Repository Name: EconStor: OA server of the German National Library of Economics - Leibniz Information Centre for Economics
    Language: English
    Type: doc-type:workingPaper
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  • 8
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    Marburg: Univ., Fachbereich Wirtschaftswiss.
    Publication Date: 2010-02-13
    Description: Contrary to some contemporary arguing, competition economics are characterized by a considerable pluralism of theories and policy paradigms. This includes deviating views on core concepts like the nature of competition, the meaning of efficiency, or the goal of antitrust. The paper demonstrates the incompatibilities of different economic competition theories and policy programs. It argues that this pluralism of concepts is both empirically sustainable and theoretically beneficial for future scientific progress. Therefore, no ultimate competition theory can ever be expected. This has to be considered when competition policy systems are designed, especially on the international level. A minimum of decentralization is necessary to maintain regulatory diversity which keeps the system open for theory innovation and changes in business environment.
    Keywords: L40 ; H77 ; B52 ; L10 ; ddc:330 ; regulatory diversity ; institutional federalism ; competition policy paradigms ; industrial economics ; centralism and decentralism ; law and economics ; methodology of science ; Wettbewerbspolitik ; Wettbewerbstheorie ; Regulierung ; Dogmengeschichte ; Institutioneller Wettbewerb ; Theorie ; Welt
    Repository Name: EconStor: OA server of the German National Library of Economics - Leibniz Information Centre for Economics
    Language: English
    Type: doc-type:workingPaper
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  • 9
    Publication Date: 2013-12-04
    Description: This report presents the findings of a mission to critically review the institutional, policy and regulatory framework for sustainable development of the Egyptian aquaculture sector. The study was undertaken by an International Expert on Aquaculture Policy, and a National Expert on Institutions, on behalf of the Project “Improving Employment and Income through the Development of Egypt’s Aquaculture Sector“, implemented by WorldFish and CARE, and funded by the Swiss Agency for Development and Cooperation(SDC). The objective of the mission was to assess the current status of the Egyptian aquaculture sector, in terms of the policy, legal and institutional environment, with a view to suggesting the major issues to be addressed within a future policy dialogue.
    Keywords: Aquaculture
    Repository Name: Aquatic Commons
    Type: Monograph or Serial Issue , NonPeerReviewed
    Format: application/pdf
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  • 10
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    Hamburg: University of Hamburg, Institute of Law and Economics (ILE)
    Publication Date: 2018-06-14
    Description: Robo advice, the automated provision of financial advice without human intervention, holds the promise of cheap, convenient and fast investment services for consumers – freed from human error or bias. However, retail investors have limited capacity to assess the soundness of the advice, and are prone to make hasty, unverified investment decisions. Moreover, financial advice based on rough and broad classifications may fail to take into account the individual preferences and needs of the investor. On a more general scale, robo advice may be a source of new systemic risk. At this stage, the existing EU regulatory framework is of little help. Instead, this paper proposes a regulatory "sandbox" – an experimentation space – as a step towards a regulatory environment where such new business models can thrive. A sandbox would allow market participants to test robo advice services in the real market, with real consumers, but under close scrutiny of the supervisor. The benefit of such an approach is that it fuels the development of new business practices and reduces the "time to market" cycle of financial innovation while simultaneously safeguarding consumer protection. At the same time, a sandbox allows for mutual learning in a field concerning a little-known phenomenon, both for firms and for the regulator. This would help reducing the prevalent regulatory uncertainty for all market participants. In the particular EU legal framework with various layers of legal instruments, the implementation of such a sandbox is not straightforward. In this paper, we propose a "guided sandbox", operated by the EU Member States, but with endorsement, support, and monitoring by EU institutions. This innovative approach would be somewhat unchartered territory for the EU, and thereby also contribute to the future development of EU financial market governance.
    Keywords: ddc:330
    Repository Name: EconStor: OA server of the German National Library of Economics - Leibniz Information Centre for Economics
    Language: English
    Type: doc-type:workingPaper
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