scholarly journals Regulatory Procedure of Post Approval Changes and Comparative Requirements of EU and USA Regulatory Regions

2021 ◽  
pp. 304-317
Author(s):  
Trivedi Ankit ◽  
Deshpande Shrikalp ◽  
Zaveri Maitreyi ◽  
Jain Praveenkumar ◽  
Kolhe Kiran
Keyword(s):  
Major Change ◽  
Systemic Review ◽  
Regulatory Requirements ◽  
Regulatory Requirement ◽  
Regulatory Review ◽  
Regulatory Regions ◽  
Major Variation ◽  
Moderate Change ◽  
A Minor ◽  
Regulatory Procedure

Aim: The current research paper describes the “Regulatory procedure of post approval changes and comparative regulatory requirement of EU and USA regulatory regions”. Study Design: The present study is a type of Retrospective analysis of Regulatory requirements and the reviewed data was subjected to systemic review. Understanding of the same led to several observations regarding regulatory requirements of EU and USA regulatory regions. Place and Duration of Study: The present study was carried out at Amneal Pharmaceutical Ltd., Ahmedabad, Gujarat, India from January, 2021 to April, 2021. Methodology: Several guidelines were profoundly reviewed to compare the requirements of post approval changes in EU and USA regulatory regions. Various regulatory review aspects were focused i.e. requirements for manufacturing sites addition/or Transfer, process parameters, container and closures, packaging and labelling of medicinal products. Results: The post approval changes in manufacturing sites of solid or semisolid dosage form considered as a major change for USA while considered as Moderate change for EU. The transfer of manufacturing section is major variation for USA while it is a minor but immediate inform type for EU. Change in manufacturing processes, containers, labelling section of sterile products considered as major variation for both. Semisolid and solid categories are falling under the same type of variation for EU and USA regulatory regions. Conclusion: This work demonstrated that the drug approvals in US, EU are the most demanding globally and the available guidance and procedures for the triggered changes are clear in both countries. Applicant should have scientific rationale to any change pertaining to Approved product ; Since the all change control are falling under the scope of Audit, so Applicant should maintain the all the records online.

Is a “Pan-Scan” Indicated in the Older Patient with a Ground Level Fall?

2018 ◽  
Vol 84 (9) ◽  
pp. 1480-1483 ◽  
Author(s):  
Christine Kim ◽  
Rebecca Sartin ◽  
Sharmila Dissanaike
Keyword(s):  
Cervical Spine ◽  
Older Patients ◽  
Clinical Signs ◽  
Major Change ◽  
Ground Level ◽  
Cervical Spine Surgery ◽  
New Findings ◽  
Area Of Concern ◽  
A Minor ◽  
New Diagnosis

Routine full-body CT “pan-scan” use in older patients after ground level falls (GLFs) is of questionable benefit. Retrospective review of new diagnosis & changes in management in patients >55 years with Glasgow Coma Scale of 15 after a GLF who received a pan-scan (routine head, cervical spine/neck, chest abdomen, and pelvis CT). Head CT results were considered separately; results described in the following paragraph pertains to cervical spine/neck, chest, abdomen, and pelvis CT. One hundred and fifty-two patients received pan-scans; 96 (63%) had new findings. Thirty-five (23%) resulted in a minor change and three (2%) in a major change in management, defined as a procedural intervention. This included tube thoracostomy in one patient and cervical spine surgery in two. A further eight patients required the use of a cervical collar. In all patients requiring intervention, there were clinical signs present that should have led to directed CT scan of area of concern. Routine pan-scans in stable, alert older patients after a GLF result in new findings in most patients, with primarily nonprocedural interventions for these additional findings.

Regulatory Review: Speech-Language Pathology and Aural Rehabilitation

2015 ◽  
Vol 20 (2) ◽  
pp. 65-67
Author(s):  
Renee Kinder
Keyword(s):  
Medicare Beneficiaries ◽  
Speech Language Pathology ◽  
Regulatory Requirements ◽  
General Outline ◽  
Regulatory Review ◽  
Aural Rehabilitation ◽  
Language Pathology ◽  
Billing And Coding ◽  
Rehabilitative Services

Understanding regulatory requirements when providing auditory rehabilitative services to Medicare beneficiaries involves understanding of Medicare guidelines and billing and coding procedures. This paper will serve to provide general outline and provide guidance on resources to allow clinicians to explore regulations specific to their region.

scholarly journals Presence of a carboxy-terminal pseudorepeat and disease-like pseudohyperphosphorylation critically influence tau’s interaction with microtubules in axon-like processes

2016 ◽  
Vol 27 (22) ◽  
pp. 3537-3549 ◽  
Author(s):  
Benedikt Niewidok ◽  
Maxim Igaev ◽  
Frederik Sündermann ◽  
Dennis Janning ◽  
Lidia Bakota ◽  
...  
Keyword(s):  
Single Molecule ◽  
Cell Biology ◽  
Major Change ◽  
Bioinformatic Analysis ◽  
Fluorescence Decay ◽  
Dissociation Rate ◽  
Tau Hyperphosphorylation ◽  
A Minor ◽  
Carboxy Terminal

A current challenge of cell biology is to investigate molecular interactions in subcellular compartments of living cells to overcome the artificial character of in vitro studies. To dissect the interaction of the neuronal microtubule (MT)-associated protein tau with MTs in axon-like processes, we used a refined fluorescence decay after photoactivation approach and single-molecule tracking. We found that isoform variation had only a minor influence on the tau–MT interaction, whereas the presence of a C-terminal pseudorepeat region (PRR) greatly increased MT binding by a greater-than-sixfold reduction of the dissociation rate. Bioinformatic analysis revealed that the PRR contained a highly conserved motif of 18 amino acids. Disease-associated tau mutations in the PRR (K369I, G389R) did not influence apparent MT binding but increased its dynamicity. Simulation of disease-like tau hyperphosphorylation dramatically diminished the tau–MT interaction by a greater-than-fivefold decrease of the association rate with no major change in the dissociation rate. Apparent binding of tau to MTs was similar in axons and dendrites but more sensitive to increased phosphorylation in axons. Our data indicate that under the conditions of high MT density that prevail in the axon, tau’s MT binding and localization are crucially affected by the presence of the PRR and tau hyperphosphorylation.

scholarly journals REGULATORY REQUIREMENTS & MARKETING AUTHORIZATION OF GENERIC DRUGS IN SINGAPORE & THAILAND

2018 ◽  
Vol 3 (1) ◽  
pp. 62-74
Author(s):  
Achin Jain ◽  
Venkatesh M. P. ◽  
Raja Mohan Reddy.G ◽  
Pramod Kumar T.M.
Keyword(s):  
Generic Drugs ◽  
Pharmaceutical Products ◽  
Critical Parameters ◽  
Regulatory Environment ◽  
Regulatory Requirements ◽  
Regulatory Requirement ◽  
Registration Process ◽  
Drug Registration ◽  
Asean Countries

The availability of generic medication is an important issue in the ASEAN region. The regulatory requirements of various countries vary from each other. Therefore, it is challenge for the companies to get drug approved for marketing simultaneously in different countries. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of medicines in their country. It not only includes the process of regulating and monitoring the drugs, but also the process of manufacturing, distribution, and promotion. The regulatory environment has similar characteristics, but drug registration requirements and processes differ among the countries. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. In ASEAN region, documentation can be filed in the ACTD format. Even though ACTD format is mandatory from 2009, the member countries have their own requirements for registration process like administrative documents, labeling. The purpose of this paper is to give a comparative overview on the Drug regulatory requirement for generics in two of the ASEAN countries which are Singapore and Thailand.

The Impact of Fine Aggregate on the Porosity of Asphalt

2014 ◽  
Vol 1065-1069 ◽  
pp. 814-817
Author(s):  
Si Zhong Sun
Keyword(s):  
Coarse Aggregate ◽  
Type Specimen ◽  
Volume Density ◽  
Fine Aggregate ◽  
Regulatory Requirements ◽  
Regulatory Requirement ◽  
Aggregate Gradation ◽  
Molding Method ◽  
Bulk Volume ◽  
The Impact

With different fine aggregate, gradation type, oil stone ratio, asphalt type specimen molding and molding method and calculate the porosity of the specimen. The experimental results show that the using basalt coarse aggregate and fine aggregate forming specimen, specimen porosity significantly larger, all are beyond the scope of regulatory requirements; If using basalt coarse aggregate and limestone fine aggregate forming specimens, specimen porosity is small, both meet regulatory requirements. The main reason is basalt fines aggregate bulk volume density is too large and not easily compacted. Recommendation: we’d better use of basalt coarse aggregate and limestone fine aggregate forming specimen, try to avoid using basalt aggregate thickness of molded specimen. If the region lacks limestone fines, we should detect the special type of basalt fine aggregate firstly. If the indicators of basalt fines are in line with the requirement, you can use, if the indicators do not meet regulatory requirement, you can not use.

An Ontology based Framework for E-Government Regulatory Requirements Compliance

2019 ◽  
Vol 11 (2) ◽  
pp. 22-42 ◽  
Author(s):  
M. Mahmudul Hasan ◽  
Dimosthenis Anagnostopoulos ◽  
George Kousiouris ◽  
Teta Stamati ◽  
Peri Loucopoulos ◽  
...  
Keyword(s):  
Personal Data ◽  
Service Development ◽  
Government Service ◽  
Regulatory Requirements ◽  
Regulatory Requirement ◽  
General Data Protection Regulation ◽  
The Public ◽  
Enormous Amount ◽  
General Data ◽  
Government Legislation

E-Government has gained an enormous amount of attention by researchers and practitioners interested in digitizing the public sector through enacting policies and regulations. Compliance of regulatory requirements from these policies and regulations is an important requirement in e-Government service development projects. However, the concepts of regulatory requirements compliance are still scattered around in developing e-Government services. This article presents an e-Government regulatory requirement compliance (eGRRC) ontology framework that describes the interrelated concepts of regulatory requirements compliance in e-Government service development. The proposed eGRRC ontology is then applied on the recently introduced general data protection regulation (GDPR) for personal data processing across European Union (EU) countries, in order to indicate how the concepts can be mapped to the defined entities. The contribution of this article is on introducing a framework for researchers and practitioners to explore regulatory requirements compliance and their interrelationships in e-Government service development. Furthermore, e-Government legislation can accordingly be modeled using on the eGRRC ontology, that serves as basis for queries to infer knowledge about the source of regulatory requirements, objectives of the regulation, various types of requirements, the services affected, orientation of regulatory rules in requirements, priorities, and amendments of regulations in e-Government service development.

scholarly journals Environmental, Social and Governance (ESG) Disclosure and Its Impact on Financial Performance of Top 100 Companies in Malaysia and Australia

2019 ◽  
Vol 9 (1) ◽  
pp. 3579-3584
Keyword(s):  
Financial Performance ◽  
Positive Impact ◽  
Annual Reports ◽  
Regulatory Requirements ◽  
Regulatory Requirement ◽  
Developed Country ◽  
The People ◽  
Definition Of ◽  
Market Capitalisation ◽  
The Impact

The definition of Environmental, Social and Governance (ESG) is not obscure. ESG involvement is the proceeding dedication by commerce to act ethically and contribute to economic growth while improving the standard of life of the employees and their families as well as the people around them. In the attempt to investigate the impact of ESG disclosure on financial performance of top 100 companies in Malaysia and Australia, this research scrutinises the annual reports of top 100 companies in Malaysia and Australia based on market capitalisation in 2017. This research has considered a comparison between Malaysia, a developing country and Australia, a developed country due to the purpose of evaluating the levels of disclosure based on different regulatory requirements on ESG while assessing the impact of ESG disclosure on Company Financial Performance (CFP). The reason being Australia is chosen as a benchmark for Malaysia to enhance their regulatory requirement for level of ESG disclosure. Overall, it is found that there is a positive impact of ESG disclosure on CFP.

scholarly journals Comparative study of Regulatory requirements of Drug Product in Emerging market

2019 ◽  
Vol 7 (3) ◽  
pp. 48-62
Author(s):  
Preeti Patel ◽  
Jitendra Kumar Badjatya ◽  
Madhuri Hinge
Keyword(s):  
Drug Product ◽  
Emerging Market ◽  
Regulatory Requirements ◽  
Regulatory Requirement ◽  
Technical Requirements ◽  
Regional Registration ◽  
Drug Registration ◽  
Pharmaceutical Industries ◽  
Requirements Quality ◽  
Human Use

Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exist in clusters with their mutual concern. The optimization and harmonization requirements has become mandatory and can be examined by the incidence of higher cost involved in availability of drugs, quality requirement of premise and research and development, regional registration requirements. Quality, Safety and Efficacy data has significance importance in dossier registration. Pharmaceutical Industries has to comply with regulatory requirement in Emerging market and for betterment of public Health and safety.The review also explains a brief about different regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier application in Emerging market.

A strategic perspective on oil and gas environmental assessment and approval

2009 ◽  
Vol 49 (2) ◽  
pp. 565
Author(s):  
Karl Heiden
Keyword(s):  
Oil And Gas ◽  
Major Change ◽  
Oil And Gas Industry ◽  
Regulatory Requirements ◽  
Gas Industry ◽  
Oil And Gas Exploration ◽  
Typical Sequence ◽  
Legislative Framework ◽  
Community Issues ◽  
Strategic Perspective

Proponents face a range of risks and uncertainties when undertaking oil and gas exploration and development activities. As well as the normal range of development and execution challenges, proponents also need to manage complex and varied external issues including stakeholder engagement and negotiations with government regulators. There are numerous examples of oil and gas activities that have faced and are continue to face significant environmental and community issues resulting in schedule delays, impacts on reputation and increased costs. In some cases, these issues have been proved to be showstoppers, causing a major change in the proposed development or withdrawal of the proposal. Regardless of how straightforward a proposed upstream oil and gas activity might be, there are typically many environment-related statues, regulations and guidelines that need to be satisfied before the development or activity can proceed. A systematic sequence must be followed for a proponent to negotiate their way through multiple application, consultation and approvals rounds. Interdependent approvals processes may run in parallel as a result of multiple jurisdictions. Project details may change and uncertainties or complexities identified part-way through the sequence, are problematic and can result in re-commencement of significant components of the sequence. The sense of disquiet within the oil and gas industry, caused by the extensive environmental regulatory requirements, has not gone unnoticed by State and Federal Government agencies. Within the past 12 months, several reviews into key pieces of legislation and the overall regulatory burden imposed on the industry have been conducted and are continuing. These reviews have allowed industry to articulate their concerns and identify risks associated with the current legislative framework. It remains to be seen what the influence that this interaction has on review recommendations and ultimately on positive changes in practice. This paper suggests that the use of a structured environmental approvals strategy is a key tool in meeting legislative requirements and the expectations of stakeholders while still being able to meet the challenges of changes to project design, timing delays and other unanticipated hurdles. This will be illustrated by examining an oil and gas proposal through a typical sequence of environmental approvals processes. It will draw attention to the complexity faced by the industry in seeking these approvals, and will highlight how a well-constructed, environmental approvals strategy can result in a better outcome for both the proponent and stakeholders.

An Industry Perspective on Risks and Mitigation Strategies Associated with Post Conduct Phase of Clinical Trial

2020 ◽  
Vol 15 (1) ◽  
pp. 28-33
Author(s):  
Seema Bhagat ◽  
Vaibhavi K. Kapatkar ◽  
Ashish Mane ◽  
Colette Pinto ◽  
Devang Parikh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Regulatory Compliance ◽  
Mitigation Strategies ◽  
Future Perspective ◽  
Regulatory Requirements ◽  
Regulatory Requirement ◽  
Regulatory Affairs ◽  
Risk Areas ◽  
Guidance Documents ◽  
Potential Risks

Aim/objective: To discuss the potential risks and their mitigation strategies in the post-conduct phase of the trial. Background: Risk management is very important for the clinical trial (CT) to ensure that the trial delivers its desired outcome(s) in terms of achieving protocol objective and regulatory compliance. Methodology: Experienced members of the clinical operation team of a pharmaceutical major underwent a series of sessions to identify risks associated with the post-conduct phase of CT and developed mitigation strategies based on own experiences and guidance documents. The risks were categorized into major, minor and critical risks. Results: In the post-conduct phase of a clinical trial, critical risk identified were; failure to communicate to the stakeholder about premature termination of the trial, mismatch of statistical analysis results and protocol objective/ regulatory requirement, clinical study report (CSR) noncompliant with regulatory requirements or delay in CSR preparation. Safety checks suggested to mitigate these risks including the development of related checklist or shell of relevant documents and its review by clinical development, quality assurance (QA) and regulatory affairs (RA) team prior to finalization. Additionally, six major and five minor risk areas were identified and safety checks were suggested. Conclusion: Sponsors must act proactively to ensure a systematic approach to conduct various post conduct trial activities and the plans to mitigate the risks that could affect the quality and outcome of the clinical trial. Future Perspective: A close coordination with all stakeholders for timely anticipation of risks and execution of mitigation strategies are required for successful CT outcomes.

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