Regulatory Affairs Research Papers - Academia.edu (original) (raw)

QUALITY BY DESIGN (QbD) IN API by DR ANTHONY MELVIN CRASTO

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- Drugs And Addiction, Medical Education, Regulatory Affairs
- by Laura Nourallah
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- Regulation And Governance, Energy Policy, Oil and gas, Regulatory Affairs

HIPAA laws related to fundraising became fully effective in 2013. What protocols should be in place to maximize philanthropic opportunities under HIPAA? What compliance measures need to be in place and assessed to properly use protected... more

- by Compliance Global Inc
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- Finance, Pharmacy, Tax Law, Compliance

IAS 8 spells out the specific principles, bases, conventions, rules and practices that are applied in preparing and presenting financial statements. When there is no specific standard that applies to a transaction, other event or... more

- by Compliance Global Inc
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- Finance, Pharmacy, Health Care, Biotechnology

The coral reefs' crisis is increasing, with the combined effects of natural and anthropogenic disturbances. It is predicted that coral reefs could extinct soon from the world. Bangladesh has only one coral Island named Saint Martin, locally known as 'Narikel Jinjira'. This is one of the most popular tourist spots in Bangladesh, entertaining thousands of tourists per year due to its unique landscape, blue water, and coral colonies' presence. This Island lost most of the coral in recent times. The coral reef ecosystem management needs to focus on the reformation of the legal and institutional frameworks for enhancing the local administration's capabilities to address the adverse effects of the stressors and promote the ecosystem services by improving the resilience. The study aims at analysing the existing institutional and legal frameworks for conserving the coral reefs. To collect data, fieldwork was conducted at Saint Martin Island and Teknaf Upazila. The related literature on legal documents was reviewed critically. It is found that despite having legal mechanisms and institutional frameworks, non-compliances with laws and poor coordination among different sectors are widespread, resulting in severe degradation of coral resources. In most of the laws, robust institutional arrangements were ignored. The study recommends integrating the legal and institutional frameworks governing the environment, tourism, and fisheries sectors. Effective marine governance, increasing coordination among different sectors, amending some existing rules, and activating MCS (monitoring, control, surveillance) system can improve the scenario.

- by Md. Mizanur Rahman
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- Institutional Theory, Coral Reef Ecology, Regulatory Affairs
- by Andrea Sardini and +1
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- Civil Law, Commercial Law, Regulatory Affairs, Blockchains
- by Divya Vohora
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- Pharmacology, Health Sciences, Pharmacy, Informatics
- by Victor Pickard
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- Critical Theory, American History, Cultural Studies, Political Sociology

A partire dall'esito referendario del 2011 e con la successiva attribuzione dei poteri di regolazione e controllo all'AEEGSI, il sistema idrico in Italia ha intrapreso un percorso di profonda evoluzione. Evoluzione che non ha solo riguardato aspetti tariffari/finanziari, ma ha anche coinvolto profondamente la sfera contabile: le società operanti nel settore infatti sono così chiamate a riflettere su quesiti attinenti la corretta modalità di registrazione dei ricavi, oppure la corretta modalità di trattamento contabile di poste tariffarie innovative. L'obiettivo dell'articolo è quello di esaminare le diverse problematiche di natura contabile associate alla regolazione tariffaria in essere, al fine di offrire uno strumento utile sia alla società idrica che al lettore del suo bilancio.

The Guia Regulatoria de Registro en Suramerica: Dietary Supplement, is an essential resource for any dietary supplements products company that wants to do business in the global marketplace. From Argentina to Venezuela, the Guide provides an updated overview of the regulatory environment for 10 countries. With more than 150 pages and organized with country-by-country chapters, the publication allows users to easily make comparisons among the countries.the Guia Regulatoria de Registro en Suramérica is an ideal starting point for individuals new to international dietary supplements regulations. It is also an invaluable tool for experienced professionals dealing with legal, regulatory, technical and marketing issues for the industry.

- by juan carlos Rondon
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- Nutrition and Dietetics, Regulatory Affairs, Dietary Supplements

Typical Elements Required to be Included in the Batch Production and the Device History Record in order to Accomplish a Quality and Cost Effective Review and Quality Management system based on current Regulatory Expectations in accordance... more

- by Compliance Global Inc
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- Pharmacy, Biotechnology, Compliance, Food and Nutrition
- by Raghavan Sampathkumar and +1
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- Discourse Analysis, Southeast Asian Studies, Marxism, Human Rights

Analytical method validation is an important requirement to support the package of information submitted to international regulatory agencies in support of new product marketing or clinical trials applications. Back in 1987, the US Food and Drug Administration (FDA) issued its first guidance on analytical methods. The document was subsequently revised in 2000 and, despite the advancement in analytical methods, there were no further updates until 2014, when a new draft was issued for public comment. Following the period of review, in July 2015, the FDA issued a new version of the guidance. The third edition is titled Analytical Procedures and Methods Validation for Drugs and Biologics.

- by Tim Sandle
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- Chemistry, Analytical Chemistry, Science Education, Measurement and Evaluation

Abstract: Can sport "moves" be protected, as such? The absence of any original or creative form of expression because of their rulebound nature, the uncertainty of the end result of a game or competition and the lack of a scripted plot are commonly cited reasons which have led courts and commentators to espouse the view that sports are not copyrightable, as such. The Court of Justice of the European Union (CJEU) in 'Premier League v QC Leisure' confirmed this view.

- by Ankur Gupta
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- Intellectual Property, Baseball, Legal Theory, Sports Management

QUALITY BY DESIGN (QbD) FOR API by DR ANTHONY MELVIN CRASTO

- by Anthony Melvin Crasto Ph.D
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- Medicinal Chemistry, Drugs And Addiction, Regulatory Affairs, QbD
- by SADIK ÜNAY
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- Economics, Public Management, Political Science, West European Politics

The analysis is focused on the national blockade of truckers which strongly affected Brazil between 21 and 31 May 2018, and its direct repercussions on the regulatory agency‘s behavior. To solve this crisis, significant part of the government‘s bargaining involved the participation of the National Agency of Terrestrial Transport (ANTT), which was responsible for the regulation of the minimal pricing policy for freight transportation throughout the country. However, the highly unstable regulations adopted by the Agency in just a few days have demonstrated the fragile autonomy of the entity, as well as revealed its de facto quasi-regulatory performance. The same perspective seems applicable to other Brazilian agencies, when analyzed the aggressive institutional pattern adopted by the Presidency, the Ministry and the Judiciary on regulatory issues, in order to weaken the agencies‘ independence and legitimacy.

The term " Halal Laws " in this paper relate to the laws of consumer protection in terms of halal product. Halal laws are crucial, since it regulates an industry that is worth an estimated of USD 2.3 trillion, annually. The Halal laws in Malaysia have been legislated for the past 40 years; from humble beginnings (Trade Description Order 1975), to standardization (MS 1500:2009) and current law (Trade Description Act 2011). However, not all countries legislate Halal laws. Some countries adopt private Halal laws which focus on Halal certification and were operated by private institutions rather than government institution. This paper intends to summarize briefly the development of the Halal laws in three countries; Malaysia (government legislated laws), Netherlands and United States (Private laws). This includes comparison between the legislated Halal laws and private Halal laws that exists globally.

- by Hadi Akbar and +1
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- Halal food, International Law, Food and Nutrition, Regulatory Affairs

Hybridity on the Ground in Peacebuilding and Development engages with the possibilities and pitfalls of the increasingly popular notion of hybridity. The hybridity concept has been embraced by scholars and practitioners in response to the social and institutional complexities of peacebuilding and development practice. In particular, the concept appears well-suited to making sense of the mutually constitutive outcomes of processes of interaction between diverse norms, institutions, actors and discourses in the context of contemporary peacebuilding and development engagements. At the same time, it has been criticised from a variety of perspectives for overlooking critical questions of history, power and scale. The authors in this interdisciplinary collection draw on their in‑depth knowledge of peacebuilding and development contexts in different parts of Asia, the Pacific and Africa to examine the messy and dynamic realities of hybridity ‘on the ground’. By critically exploring the power dynamics, and the diverse actors, ideas, practices and sites that shape hybrid peacebuilding and development across time and space, this book offers fresh insights to hybridity debates that will be of interest to both scholars and practitioners.

- by Srinjoy Bose, PhD and +2
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- Gender Studies, Anthropology, International Relations, Development Studies

Regulation of the financial sector has always been a prime concern of states and the regulatory bodies which usually put in place. This work undertakes an overview of Malaŵi's financial sector and the dominance of banking. It discusses regulatory models and concludes that Malaŵi has a silo regulatory matrix. It distinguishes regulation and supervision and notes that in most jurisdictions these powers reside in the same body. It analyses the independence of the financial regulator and concludes that the regulator in Malaŵi is under the direct control of the political executive, factually and legally. It proposes a regulatory framework which takes cognizance of the political economy of the country. It also offers solutions on how some of the projected bottlenecks or hurdles can be overcome.

- by Anindya Banerjee
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- Pharmacology, Pharmacovigilance, Clinical Pharmacology, Regulatory Affairs

Annex 1 to the European Union Good Manufacturing Practice (GMP) guidelines is now under formal revision, with a concept paper issued during February 2015 and with a view to implement the new document during 2016. Annex 1 is a key part of European GMP for it affects the production and filling of sterile products. The document is also of global importance as manufacturing centers importing into Europe need to comply with the guidance. In addition, previous versions of the Annex have proven to be influential on other international regulators.

- by Tim Sandle
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- Pharmacology, Pharmacy, Technology, Pharmaceutical Technology
- by Emad Aysha
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- Indonesia, Economic integration, Nanotechnology, Regulatory Affairs

The fact that foods can provide additional medicinal health benefits beyond basic energy requirements and nutritional needs for survival, has been proven through rigorous scientific researches over the years. Although Turkey is historically believed to be the ancient origin of a
decent number of fermented probiotic foods and beverages, there is still little awareness amongst the overall populace regarding the usefulness of these medicinal products also known as functional foods. Hence, the current review article discusses probiotics as a top notch variety of functional foods and encapsulates their history as well as some proven beneficial effects of some known probiotic microorganisms on human health. More importantly, greater emphasis is placed on elucidating scientific data on seven fermented traditional probiotic beverages of
Turkish origin namely boza, kefir, ayran, shalgam, hardaliye, koumiss and gilaburu juice. The paper concisely describes their main characteristics, probiotic microbiota composition, production techniques as well as nutritional properties and some potential health benefits derivable from their consumption.

- by OLUWASEUN T . ALADEBOYEJE
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- Microbiology, Food Science, Regulatory Compliance, Probiotics