scholarly journals A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013–2016

2020 ◽  
Vol 54 (6) ◽  
pp. 1428-1435
Author(s):  
Prisha Patel ◽  
Daniela Marreco Cerqueira ◽  
Gustavo Mendes Lima Santos ◽  
Renata de Lima Soares ◽  
Varley Dias Sousa ◽  
...  
Keyword(s):  
Performance Improvement ◽  
Review Process ◽  
Response Times ◽  
Regulatory Agencies ◽  
Regulatory Review ◽  
Performance Targets ◽  
Approval Time ◽  
Timely Access ◽  
Data Points ◽  
Regulatory Assessment

Abstract Background The Brazilian health regulatory agency (Agência Nacional de Vigilância Sanitária, ANVISA) has embarked on transformational initiatives to fulfill its mandate to provide timely access to safe, effective, and quality therapeutics. A new Brazilian law was enacted to provide the agency with greater flexibility. Optimizing Efficiencies in Regulatory Agencies (OpERA) is a regulatory-strengthening program that seeks to provide benchmarking data that can be used to define performance targets and focus performance improvement. The objective of this study was to use OpERA methodology to undertake a retrospective analysis of the timelines associated with important components of the ANVISA regulatory review process to establish a baseline against which the influence of the new law could be measured. Methods The OpERA tool was used to collect specific milestone data that identify time periods, review stages, and data points for products approved by ANVISA 2013–2016. Results For the 138 products approved in this cohort, the overall median approval time was 795 days. ANVISA and submitting companies will need to reduce their review and response times by approximately half in order to meet the total time goal of 365 days. Conclusions The observations from this baseline study have identified opportunities for ANVISA and sponsor companies to collaborate to reduce regulatory assessment times while assuring the timely approval of safe and effective, quality medicines. These analyses will be repeated to determine how the provisions of the new Law will impact the activities of ANVISA and the extent of sponsors' contributions to this effort.

scholarly journals Evaluation of the Regulatory Review Process in Zimbabwe: Challenges and Opportunities

2021 ◽  
Author(s):  
Tariro Sithole ◽  
Gugu Mahlangu ◽  
Sam Salek ◽  
Stuart Walker
Keyword(s):  
Decision Making ◽  
Review Process ◽  
International Standards ◽  
World Health ◽  
Regulatory Agencies ◽  
Regulatory Review ◽  
Formal Framework ◽  
Challenges And Opportunities ◽  
Good Review ◽  
Reference Agency

Abstract Purpose The aims of this study were to assess the current regulatory review process of the Medicines Control Authority of Zimbabwe (MCAZ), identify key milestones and target timelines, evaluate the overall performance from 2017 to 2019, identify good review practices, evaluate the quality of decision-making processes, and identify the challenges and opportunities for improvement. Methods A questionnaire was completed by the MCAZ. The agency has participated in the Optimising Efficiencies in Regulatory Agencies (OpERA) program, a multinational endeavor to characterize assessment procedures and metrics associated with regulatory agencies and regional regulatory initiatives. Data identifying the milestones and overall approval times for all products registered MCAZ from 2017 to 2019 were collected and analyzed. Results The MCAZ conducts a full review of quality, safety, and efficacy data for generics and biosimilars not approved by a reference agency, an abridged review for products approved by a reference agency and a verification review for World Health Organization prequalified products under the collaborative registration procedure. The highest number of reviewed products is generics manufactured by foreign companies. There has been an improvement in review times for all categories of products over the three-year period. Guidelines, standard operating procedures, and review templates are in place and the majority of indicators for good review practices are implemented. Although quality decision-making practices are implemented, there is no formal framework in place. Conclusion The MCAZ successfully implements three types of review models in line with international standards. Overall, target timelines are realistic and what is achievable with the current available resources. Recommendations made such as the review of available human resources, separation of agency and company time when setting and measuring targets, review of the templates and benefit-risk framework used for abridged review, and development of a decision-making framework present opportunities for an enhanced regulatory review process.

scholarly journals A Novel and Integrated Architecture for Securing Communication in IoT

2019 ◽  
Vol 9 (2) ◽  
pp. 924-929
Keyword(s):  
Energy Savings ◽  
Response Times ◽  
Security And Privacy ◽  
Iot Security ◽  
Authentication Mechanism ◽  
Use Of Data ◽  
Data Points ◽  
Integrated Architecture ◽  
Cost Efficient ◽  
Lightweight Encryption

Although the IoT opens the door to endless possibilities, but it is also associated with many risks because all devices connected to the internet involve the use of data points. Therefore, it is essential to ensure IoT security and privacy. A review of existing research works highlights the usage of traditional security scheme based on cryptography for data transmission among IoT nodes and gateways. The proposed system proposes an integrated model that combines lightweight encryption technique with robust and cost-efficient authentication mechanism. The proposed system introduces digital signature-based authentication and complexity minimization in order to resist the involvement of any kind of unknown attacks. The simulation outcome of this model exhibits reliable security, faster response times and energy savings for IoT nodes.

scholarly journals Global Surgery, Obstetric, and Anesthesia Indicator Definitions and Reporting: An Utstein Consensus Report

2021 ◽  
Author(s):  
Justine Ina Davies ◽  
Adrian W. Gelb ◽  
Julian Gore-Booth ◽  
Janet Martin ◽  
Jannicke Mellin-Olsen ◽  
...  
Keyword(s):  
Low Income ◽  
Data Science ◽  
Health Indicators ◽  
Obstetric Care ◽  
Global Surgery ◽  
Low Income Countries ◽  
Financial Risk Protection ◽  
Current Time ◽  
Timely Access ◽  
Data Points

Background Indicators to evaluate progress towards timely access to safe surgical, anaesthesia, and obstetric (SAO) care were proposed in 2015 by the Lancet Commission on Global Surgery. Despite being rapidly taken up by practitioners, datapoints from which to derive them were not defined, limiting comparability across time or settings. We convened global experts to evaluate and explicitly define - for the first time - the indicators to improve comparability and support achievement of 2030 goals to improve access to safe affordable surgical and anaesthesia care. Methods and findings The Utstein process for developing and reporting guidelines through a consensus building process was followed. In-person discussions at a two day meeting were followed by an iterative process conducted by email and virtual group meetings until consensus was reached. Participants consisted of experts in surgery, anaesthesia, and obstetric care, data science, and health indicators from high, middle, and low income countries. Considering each of the six indicators in turn, we refined overarching descriptions and agreed upon data points needed for construction of each indicator at current time (basic data points), and as each evolves over 2-5 (intermediate) and >5 year (full) timeframes. We removed one of the original six indicators (one of two financial risk protection indicators was eliminated) and refined descriptions and defined data points required to construct the 5 remaining indicators: geospatial access, workforce, surgical volume, perioperative mortality, and catastrophic expenditure. Conclusions To track global progress toward timely access to quality SAO care, these indicators – at the basic level - should be implemented universally. Intermediate and full evolutions will assist in developing national surgical plans, and collecting data for research studies.

Abstract P833: Standardized Protocols Reduce Response Times for LVO Strokes

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Vanesa K Vanderhye ◽  
Lynda Christel ◽  
Ali Turkmani ◽  
Kara A Sands
Keyword(s):  
Response Times ◽  
Vessel Occlusion ◽  
Early Reperfusion ◽  
Notification System ◽  
Stroke Treatment ◽  
Phone Calls ◽  
Data Points ◽  
Stroke Center ◽  
High Level ◽  
Cerebral Reperfusion

Introduction: Acute ischemic stroke treatment is time sensitive especially for large vessel occlusion (LVO) strokes with the goal to achieve early cerebral reperfusion. Research suggests standardized protocols incorporate early notification to reduce time from arrival to mechanical thrombectomy (MT). The MT workflow at a certified stroke center required multiple phone calls to mobilize staff and resources resulting in treatment delays. The average time from neurosurgery notification (NN) to case start (CST) was 60.4 minutes (min) resulting in average door-to-puncture (DTP) time of 124.8 min further delaying early reperfusion. Purpose: Standardize MT workflows and incorporate a 1-step notification system to reduce average NN to CST by 20% to 45 min to achieve 90 min average DTP time by 90 days post implementation. Methods: Baseline data for MT cases admitted 1/1/18 - 9/2/19 arriving in the emergency room (ER) and occurring inpatient were abstracted from stroke alert logs and the electronic health record. MT transfers were excluded. A multidisciplinary group of key stakeholders completed both high level process and workflow analysis maps and mock simulations to identify gaps. Both an analysis of variance and Tukey-Kramer’s T Test were performed revealing NN to CST was most statistically significant (p<.0001) and largest root cause for overall increased DTP times. New service-specific workflows were developed including 1-step notification activated via an existing group paging system used for other purposes. Activation notified on call staff of the MT case and patient location. Data points collected were NN to CST (ED and inpatient) and DTP (ED only). Results: Average NN to CST time was 26.7 min (33.3 min decrease or 55.1%; p<.0001, n=12) resulting in DTP average of 83.4 min (41.4 min decrease or 35.3%, n=10) 90 days post-implementation. The paging system was cost-neutral due to existing licensing agreements. Conclusion: In conclusion, streamlined workflows incorporating 1-step notification reduced time from notification to staff response so MT procedures could start sooner. A multidisciplinary approach along with key stakeholder buy-in was instrumental in successful project implementation.

Juggling With Both Hands Tied Behind My Back: Teachers’ Views and Experiences of the Tensions Between Student Well-Being Concerns and Academic Performance Improvement Agendas

2019 ◽  
Vol 56 (6) ◽  
pp. 2644-2673 ◽  
Author(s):  
Alison Willis ◽  
Mervyn Hyde ◽  
Ali Black
Keyword(s):  
Mental Health ◽  
Performance Improvement ◽  
Secondary School Teachers ◽  
Well Being ◽  
Health Issues ◽  
Academic Improvement ◽  
Performance Targets ◽  
Australian State ◽  
And Performance ◽  
Primary And Secondary School

Youth mental health in Australia is concerning with 25% of young people reported as experiencing mental health issues in a 12-month period. Meanwhile, Australian schools march forward with academic improvement agendas. Survey research conducted among primary and secondary school teachers, most drawn from the Australian state of Queensland, revealed that although teachers value student well-being initiatives, they are experiencing very real tensions dealing with student mental health concerns and performance targets, which is complicated by a lack of confidence in the efficacy of well-being programs in schools. These findings raise concerns about the need for government authorities, school leaders, and teacher education providers to further investigate the need for balance between school performance improvement agendas and student well-being concerns.

scholarly journals US Food and Drug Administration Perspectives on Clinical Mass Spectrometry

2016 ◽  
Vol 62 (1) ◽  
pp. 41-47 ◽  
Author(s):  
Julia Tait Lathrop ◽  
Douglas A Jeffery ◽  
Yvonne R Shea ◽  
Peter F Scholl ◽  
Maria M Chan
Keyword(s):  
Mass Spectrometry ◽  
Clinical Trials ◽  
Drug Administration ◽  
Review Process ◽  
Food And Drug Administration ◽  
Regulatory Review ◽  
In Vitro Diagnostic ◽  
Guidance Documents ◽  
Proteins And Peptides

Abstract Mass spectrometry–based in vitro diagnostic devices that measure proteins and peptides are underutilized in clinical practice, and none has been cleared or approved by the Food and Drug Administration (FDA) for marketing or for use in clinical trials. One way to increase their utilization is through enhanced interactions between the FDA and the clinical mass spectrometry community to improve the validation and regulatory review of these devices. As a reference point from which to develop these interactions, this article surveys the FDA's regulation of mass spectrometry–based devices, explains how the FDA uses guidance documents and standards in the review process, and describes the FDA's previous outreach to stakeholders. Here we also discuss how further communication and collaboration with the clinical mass spectrometry communities can identify opportunities for the FDA to provide help in the development of mass spectrometry–based devices and enhance their entry into the clinic.

The Transfusion Services Committee—Responsibilities and Response to Adverse Transfusion Events

Hematology ◽  
2005 ◽  
Vol 2005 (1) ◽  
pp. 483-490 ◽  
Author(s):  
Ira A. Shulman ◽  
Sunita Saxena
Keyword(s):  
Performance Improvement ◽  
Review Process ◽  
High Volume ◽  
The United States ◽  
Adverse Outcomes ◽  
Data Driven ◽  
Medicaid Program ◽  
And Performance ◽  
To Receive

Abstract Healthcare institutions in the United States must review blood transfusion practices and adverse outcomes in order to receive payments from the Centers for Medicare/Medicaid program, but it is not required for a specific committee to be assigned to oversee the review process. Regardless of the group or individuals responsible, the review process must include a program of quality assessment and performance improvement that is ongoing, hospital-wide, and data-driven, reflects the complexity of the hospital’s organization and services, and involves all hospital departments and services (including those contracted). To be most effective, the performance improvement activity should be prioritized around high-risk, high-volume activities and/or in problem-prone areas. Even if a hospital elects not to receive payments from Medicare, it must still comply with applicable sections of the Code of Federal Regulations pertaining to transfusion services such as the follow up of adverse outcomes of transfusion.

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