Promoting system – MPS 2016 http://mps2016.org/ Sun, 25 Sep 2022 21:44:43 +0000 en-US hourly 1 https://wordpress.org/?v=5.9.3 https://mps2016.org/wp-content/uploads/2021/10/icon-4-120x120.png Promoting system – MPS 2016 http://mps2016.org/ 32 32 Sanwo-Olu at Chatham House, accuses world leaders of a sustainable health system – https://mps2016.org/sanwo-olu-at-chatham-house-accuses-world-leaders-of-a-sustainable-health-system/ Sun, 25 Sep 2022 20:24:00 +0000 https://mps2016.org/sanwo-olu-at-chatham-house-accuses-world-leaders-of-a-sustainable-health-system/ Lagos State Governor Babajide Sanwo-Olu has called on world leaders, global think tanks and public office holders to work towards building a sustainable healthcare system for all and facilitating the access for the poor and underserved. Speaking on “Universal Health Coverage in Nigeria: Optimizing Institutional Opportunities and Partnerships for Success” this weekend at the Royal […]]]>

Lagos State Governor Babajide Sanwo-Olu has called on world leaders, global think tanks and public office holders to work towards building a sustainable healthcare system for all and facilitating the access for the poor and underserved.

Speaking on “Universal Health Coverage in Nigeria: Optimizing Institutional Opportunities and Partnerships for Success” this weekend at the Royal Institute of International Affairs, Chatham House, Governor Sanwo-Olu instructed a think tank to optimize institutional opportunities and partnerships for achieving Universal Health Coverage (UHC).

“To achieve UHC, developing countries must first strive to provide their residents with a minimum package of basic health services, delivered free at the point of care using subsidies, controlled premiums or a pre-defined tariff system, in government-regulated or public or private-affiliated establishments,” he said.

Governor Sanwo-Olu said Lagos State, as Africa’s most populous city, financial hub and Africa’s 5th largest economy on the continent, has strategically strengthened the health system in pursuit of universal health coverage.

He said Lagos State was using policies to strengthen its health systems, pushing for the achievement of UHC, which the state sees as a journey and not a destination.

“In Lagos State, we believe that policy is the single most effective tool that governments can deploy in the pursuit of stronger health systems and ultimately to move closer to UHC. The right policies will lead to the development of robust health financing systems that will meet the needs of our huge and growing population,” he said.

Speaking on some of his administration’s policies aimed at strengthening the healthcare system, Governor Sanwo-Olu said that the Lagos State government has consistently increased its budget allocation and efficiency to healthcare over the years. years, noting that his government’s desire is to eventually match Abuja. Declaration of 15 percent.

He said that his administration, through its capital infrastructure program, is upgrading and renovating its existing primary and secondary health facilities in the short term and has started building new primary, secondary health facilities. and specialties designed for the future.

“We recognize that the government cannot fill the funding gap in the health system without the support of the private sector. In an effort to encourage public-private partnerships, we have established various institutions such as the Office of Public-Private Partnerships (OPPP) and IBILE Holdings, a private company owned by the State of Lagos with the aim of engage with the private sector. These institutions are mandated to facilitate and expedite PPP opportunities in Lagos State.

“We understand the need for good governance within the administrative structure of the health system and therefore we have inaugurated councils for all agencies within the Lagos State Department of Health. This has gone a long way in building the capacity of line sub-agencies, keeping them focused on their mandates.

“We believe in health insurance as a tool we can leverage to quickly cover ground in our quest for UHC and so we have put our full support behind the new National Health Insurance Law and mandated our management agency of Lagos State Health. (LASHMA) to domesticate and enroll Lagos residents into the Lagos State Social Health Insurance Scheme.

“We are leveraging partnerships with global organizations such as the Bill and Melinda Gates Foundation and the Global Fund, among others, to explore innovative ways to strengthen our primary health care system. In fact, I believe that the decisions of these organizations to directly fund a sub-national like Lagos State speaks to the clarity of our vision and our commitment to delivering results,” he said.

Governor Sanwo-Olu also disclosed that his administration has entered into innovative programs in partnership with the private sector to upgrade equipment in state secondary health centers and set up specialized health facilities.

“We have launched two pilot projects: Lagos State Oncology Center and Omotunde Ajoke Cole Smart Hospital. The success of these projects will mark a new dawn in our healthcare system, where the best of the public and private sectors will come together to provide affordable, world-class healthcare.

“We are working hard to improve the quality of human resources we have in our health centers. We also use a meritocracy system to appoint medical directors (MDs) in health centers and provide ongoing medical and administrative training.

“We understand the critical role played by logistics within our health system and we ensure that people, essential medicines and consumables are easily transported within our health system,” he said. .

Governor Sanwo-Olu said that while the Lagos State government is working on innovative mechanisms to pay for healthcare, it must also ensure that it puts in place a healthcare delivery system able to provide decent health services to the people of the state.

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SABB joins the Buna payment system of the Arab Monetary Fund https://mps2016.org/sabb-joins-the-buna-payment-system-of-the-arab-monetary-fund/ Wed, 21 Sep 2022 05:06:26 +0000 https://mps2016.org/sabb-joins-the-buna-payment-system-of-the-arab-monetary-fund/ Saudi Arabia – Saudi British Bank (SABB) has joined Buna, the Arabic payment system operated by the Arab Regional Payments Clearing and Settlement Organization (ARPCSO), a subsidiary of the Arab Monetary Fund (AMF), as part of of its commitment to providing the best innovative solutions to improve the customer experience. This will enable them to […]]]>

Saudi Arabia – Saudi British Bank (SABB) has joined Buna, the Arabic payment system operated by the Arab Regional Payments Clearing and Settlement Organization (ARPCSO), a subsidiary of the Arab Monetary Fund (AMF), as part of of its commitment to providing the best innovative solutions to improve the customer experience.

This will enable them to send and receive cross-border multi-currency payments in a safe, cost-effective, risk-controlled and transparent manner.

Buna is the first regional system specializing in the provision of clearing and settlement services for payments in multiple currencies in the Arab region, which provides modern payment solutions that comply with international standards, principles and compliance requirements. The system aims to increase opportunities for economic and financial integration in the region, in addition to strengthening investment relations with trading partners.

Yasser Al-Barrak, Managing Director of Corporate and Institutional Banking at SABB, said: “We are proud to have joined the ‘Buna’ platform, as this partnership aligns with the bank’s digital transformation plans, providing the latest bank payment solutions that comply with international standards and principles, and achieve excellence in payment operations in the region by leveraging the latest and most secure technologies.

“SABB’s commitment to the Kingdom’s Vision 2030 is reinforced by encouraging such projects, which play an important role in stimulating the economic and financial growth of the Kingdom and the region as a whole.” he added.

Mehdi Manaa, Managing Director of Buna, said: “We are delighted to welcome Saudi British Bank as a participant in Buna. We look forward to continuing to work with SABB to improve cross-border payments in line with global standards and international best practices. With more banks joining Buna from different countries, we are enriching our network and realizing our vision to empower economies and strengthen integration within the Arab world. On this occasion, I would also like to thank the Central Bank of Saudi Arabia (SAMA) for its continued support to Buna. »

Copyright 2022 Al Hilal Publishing and Marketing Group Provided by SyndiGate Media Inc. (Syndigate.info).

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Summit Midstream Partners (SMLP) Announces the Sale of its Bison Gas Gathering System in North Dakota https://mps2016.org/summit-midstream-partners-smlp-announces-the-sale-of-its-bison-gas-gathering-system-in-north-dakota/ Mon, 19 Sep 2022 20:33:02 +0000 https://mps2016.org/summit-midstream-partners-smlp-announces-the-sale-of-its-bison-gas-gathering-system-in-north-dakota/ Get instant alerts when news breaks on your stocks. Claim your one week free trial for StreetInsider Premium here. Summit Midstream Partners, LP (NYSE: SMLP) (“Summit”, “SMLP” or the “Partnership”) today announced that its wholly-owned subsidiary, Summit Midstream Holdings, LLC (“SMP Holdings”), has signed and completed the sale of Bison Midstream, LLC (“Bison Midstream”), its […]]]>

Get instant alerts when news breaks on your stocks. Claim your one week free trial for StreetInsider Premium here.


Summit Midstream Partners, LP (NYSE: SMLP) (“Summit”, “SMLP” or the “Partnership”) today announced that its wholly-owned subsidiary, Summit Midstream Holdings, LLC (“SMP Holdings”), has signed and completed the sale of Bison Midstream, LLC (“Bison Midstream”), its gas gathering system in Burke and Mountrail counties, North Dakota to Steel Reef Infrastructure Corp. (“Steel Reef” or the “Company” through its wholly owned subsidiary Steel Reef US Corp.), an integrated owner and operator of associated gas capture, gathering and processing assets in North Dakota North and Saskatchewan, for a cash consideration of $40 million, subject to customary transaction adjustments.

Heath Deneke, President, CEO and Chairman of the Board, said, “We are pleased to announce this strategic transaction with Steel Reef. Combined with the previously announced divestiture of the Lane Gathering and Processing System earlier this summer, the sale of Bison Midstream represents a continuation of our strategy to rationalize our asset portfolio through balance sheet enhancing transactions while creating additional financial flexibility to reinvest in more strategic scale development opportunities across our footprint. With the sale of Bison Midstream, Summit will focus in the Williston Basin on growing its crude oil gathering systems and produced water primarily located in Williams and Divide counties, North Dakota. We remain pleased with the level of customer development activity in Central Williams County and pro forma for the transaction, we continue to expect over 50 new wells behind our liquids system in 2023. Pro forma for the transaction, SMLP has approximately $90 million drawn on its $400 million ABL credit facility, which translates to more than $300 million of available liquidity. We continue to expect a trend up our 2022 Adjusted EBITDA guidance range of $205 million to $220 million. »

Presentation of the bison

The Bison Midstream system is located in Mountrail and Burke counties in northwestern North Dakota. Bison Midstream collects, compresses and processes the associated natural gas that exists in the crude oil stream produced from the Bakken and Three Forks shale formations. Gathering agreements for the Bison Midstream system include long-term, fee-based or percentage-of-revenue contracts. Volume throughput on the Bison Midstream system is supported by area concessions from its major customers. A major independent US crude oil and natural gas company and Chord Energy Corporation are major customers of Bison Midstream. Natural gas collected on the Bison Midstream system is delivered to the Aux Sable Midstream LLC (“Aux Sable”) Palermo packing plant in Palermo, ND, and then delivered to downstream pipelines serving the plant Aux Sable’s 2.1 Bcf/d natural gas processing plant in Channahon, Illinois. .

Legal advisers

Locke Lord LLP served as counsel to Summit and Bracewell LLP served as counsel to Steel Reef.

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New system to reduce taxi wait times in busy areas https://mps2016.org/new-system-to-reduce-taxi-wait-times-in-busy-areas/ Sun, 18 Sep 2022 09:18:51 +0000 https://mps2016.org/new-system-to-reduce-taxi-wait-times-in-busy-areas/ A new system announced on Sunday analyzes data to automatically direct taxis to the most in-demand locations in Dubai. The “Smart Direction” system is powered by artificial intelligence (AI) to determine the most requested locations, as indicated by a forecasting system. The project will reduce fuel consumption and increase the number of journeys per vehicle, […]]]>

A new system announced on Sunday analyzes data to automatically direct taxis to the most in-demand locations in Dubai. The “Smart Direction” system is powered by artificial intelligence (AI) to determine the most requested locations, as indicated by a forecasting system.

The project will reduce fuel consumption and increase the number of journeys per vehicle, the Roads and Transport Authority (RTA) said.

The system is part of a package of improvement projects and services approved for the Dubai Taxi Corporation (DTC). These initiatives involve expanding the use of artificial intelligence technologies, automating processes to increase the level of operational efficiency of taxi services and improving road safety.

Automation of robotic processes

Mattar Al Tayer, Managing Director and Chairman of the Board of RTA, said: “Approved projects include Robotic Process Automation (RPA), which will improve vehicle operational efficiency by 3%, increase the accuracy of data and forecasts of the hottest areas by 10%, reduce travel time and increase the percentage of productive kilometers.It will also increase the travel acceptance rate by 15% and reduce the cost of human resources by 20%.

Smart collection

This project aims to provide smart, digital and sustainable services to drivers by streamlining collection procedures and improving operational efficiency. It also aims to increase the operational efficiency of vehicles, increase the number of trips and reduce maintenance and fuel costs.

New school buses

Al Tayer inspected some of the 236 newly deployed school buses comprising of 52-seat and 36-seat categories. The buses are equipped with the latest security means, including interior and exterior cameras, a student inspection system, motion detectors and an automatic fire suppression system.

In the first half of 2022, DTC generated MAD 118 million in profits and signed seven commercial agreements for taxis, limousines and buses.

Copyright © 2022 Khaleej Times. All rights reserved. Provided by SyndiGate Media Inc. (Syndigate.info).

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JABSOM doctor helps in Ukrainian war zone https://mps2016.org/jabsom-doctor-helps-in-ukrainian-war-zone/ Fri, 16 Sep 2022 23:58:18 +0000 https://mps2016.org/jabsom-doctor-helps-in-ukrainian-war-zone/ Andy Oishi takes a photo in front of the Ukrainian flag at the Fatherland Monument in Kyiv, Ukraine. Andy Oishi is known for bringing its gift of healing to war-torn countries and disaster-stricken areas. He has been a physician for 26 years at Kuakini Medical Center and Queen’s Medical Center, and is an Assistant Professor […]]]>
Andy Oishi takes a photo in front of the Ukrainian flag at the Fatherland Monument in Kyiv, Ukraine.

Andy Oishi is known for bringing its gift of healing to war-torn countries and disaster-stricken areas. He has been a physician for 26 years at Kuakini Medical Center and Queen’s Medical Center, and is an Assistant Professor of Surgery at the University of Hawaii in Manoa John A. Burns School of Medicine (JABOM).

Oishi, a JABOM former student, participated in humanitarian missions as part of Samaritan’s Purse, an organization that helps injured people around the world. He provided surgical care during the 2017 Battle of Mosul in Iraq and treated patients when Haiti was hit by a 7.2 magnitude earthquake in 2021. As part of the response team in the event of an organizational disaster (DART), Oishi helps respond to crises and helps victims of war, natural disasters, disease and famine.

His last posting took him to Ukraine in June to provide medical aid to war-affected people, which required Oishi to be deployed for a month.

Overcome, adapt to challenges

oishi on the bus
Oishi on the bus to Ukraine

During his travels to his main mission, including a 22-hour flight and a 24-hour bus ride, Oishi faced another obstacle.

“It was fifteen hours into the bus ride that I started getting this feeling of COVID sickness,” Oishi recalled. “My first five days in Ukraine were difficult because I was in COVID isolation and trying to work, but I was in a foreign country. I didn’t know the language and couldn’t find any performer because I was considered contagious.

Once out of the COVID-19 lockdown, Oishi was ready to get to work, but soon realized the mission had changed. His mission leaders pivoted his role to distributing medical supplies instead.

“It was kind of an interesting experience because in previous DARTs I had been deployed to do trauma surgery or acute medical care,” Oishi said. “But the war in Ukraine has evolved rapidly. [The Ukranians] put in fact [up] a big fight and pushed Russia out of the central part of the country, and Ukraine became quite stable very quickly, except for the eastern and southern areas where Russia had occupied. There was a huge need for supplies for all the medical structures in the occupied areas.

By the time Oishi left Ukraine, Samaritan’s Purse had distributed 200 tons of medical supplies. Although Oishi had no knowledge of the Ukrainian language, there were translators able to communicate with the local community they worked with.

To do his job, Oishi had to develop skills he doesn’t normally use in his practice: contacting hospital administrators, writing hospital contracts, arranging and then delivering supplies to those hospitals. All these transactions were carried out in the Ukrainian language.

Danger in the war zone

andy oishi wearing a bulletproof vest
Oishi dons a bulletproof vest and helmet for protection.

Meanwhile back in HawaiiOishi’s wife, Laurie Tamalso a JABOM alumna, received this text from her husband: “Missiles are hitting the town where we are. We hide in a basement. They later discovered that at least three people had been killed and 15 injured in the attack.

Tam said, “I waited a while, then a few hours later I texted her, ‘Are you okay?’ My friends and family were hoping the reason he wasn’t responding was because he was in a basement with no wifi. And then there were hours when I didn’t hear from him.

Oishi later replied that he fell asleep in the basement, something they can now look back on and laugh at. He added that his team spent their time in the basement having deep conversations and building camaraderie.

“For me, missiles and bombs were never the biggest concern,” said Oishi, who had prepared for the worst and thought of a game plan with his wife before proceeding with the mission. “The biggest concern was not being able to complete the tasks assigned to me.”

Despite all the challenges they faced throughout this experience, the couple found peace in their faith in God during this time of separation.

Make an impact with medical knowledge

Oishi and Tam encourage their students and residents to use the medical knowledge and skills they learn at JABSOM and find ways to make a difference here and in other parts of the world.

“We live in the safest and wealthiest country in the world,” Oishi said. “We think that’s how life is, but it’s not really like that in most countries around the world. Life can be very difficult in those places.

He added, “We have all these opportunities to serve and grow our faith, and this was definitely an opportunity where our faith grew.”

Learn more about Oishi’s mission at JABOM.

Oishi with some of his Samaritan’s Purse teammates.
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A primary lymphoma of the central nervous system https://mps2016.org/a-primary-lymphoma-of-the-central-nervous-system/ Thu, 15 Sep 2022 13:34:22 +0000 https://mps2016.org/a-primary-lymphoma-of-the-central-nervous-system/ In the absence of evidence of systemic involvement, primary central nervous system lymphoma (PCNSL) is a rare extranodal lymphomatous cancer that affects the brain, spinal cord, leptomeninges, or vitreoretinal region. Because the clinical presentation of PCNSL differed between the affected structures, a high level of suspicion was required to make the diagnosis. The start of […]]]>

In the absence of evidence of systemic involvement, primary central nervous system lymphoma (PCNSL) is a rare extranodal lymphomatous cancer that affects the brain, spinal cord, leptomeninges, or vitreoretinal region. Because the clinical presentation of PCNSL differed between the affected structures, a high level of suspicion was required to make the diagnosis.

The start of treatment was crucial for optimal neurological recovery and disease management. The invention and widespread use of high-dose methotrexate (MTX) chemotherapy, considered the cornerstone of first-line combination chemotherapy treatment, has greatly improved the prognosis of PCNSL in recent decades. After MTX therapy is completed, a consolidation approach is often needed to prolong the duration of the response. Radiation therapy, maintenance therapy, nonmyeloablative chemotherapy, or myeloablative therapy followed by autologous stem cell transplantation can all be used as consolidation. Unfortunately, relapses often occur even after consolidation, and the 5-year survival rate is only 30-40%. Activation of the B-cell receptor pathway, immune evasion, and a reduced tumor immunological microenvironment have all been linked to important pathways in tumor pathogenesis through new insights into the pathophysiology of PCNSL.

As a result of these discoveries, whole new tiny compounds that target these abnormal pathways have been discovered. The Bruton tyrosine kinase inhibitor ibrutinib and immunomodulating drugs (lenalidomide or pomalidomide) have demonstrated encouraging clinical response rates for relapsed/refractory PCNSL and are being used more often to treat recurrent disease. The clinical presentation of the PCNSL, the workup and staging method, as well as an overview of recent developments in knowledge of pathogenesis and current therapeutic approaches for immunocompetent patients were all included in the study.

Reference: ashpublications.org/blood/article/140/9/971/477460/Primary-central-nervous-system-lymphoma

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Khurana maintains importance of college house system despite early departure of Leverett Deans | New https://mps2016.org/khurana-maintains-importance-of-college-house-system-despite-early-departure-of-leverett-deans-new/ Wed, 14 Sep 2022 05:05:24 +0000 https://mps2016.org/khurana-maintains-importance-of-college-house-system-despite-early-departure-of-leverett-deans-new/ College Dean Rakesh Khurana declined to comment on the early exit of former faculty deans from Leverett House, but affirmed the importance of Harvard’s house system in an interview Monday. An essential part of Harvard’s undergraduate experience is its residential system, which places each undergraduate student in one of 12 upperclass houses led by a […]]]>

College Dean Rakesh Khurana declined to comment on the early exit of former faculty deans from Leverett House, but affirmed the importance of Harvard’s house system in an interview Monday.

An essential part of Harvard’s undergraduate experience is its residential system, which places each undergraduate student in one of 12 upperclass houses led by a pair of faculty deans. Khurana said the College does not comment on personnel issues when asked about the circumstances surrounding the departure of former Leverett faculty deans Brian D. Farrell and Irina P. Ferreras, who resigned suddenly in June.

The Crimson reported earlier this month that some affiliates allege Farrell and Ferreras’ leadership has been marred by a pattern of mismanagement. Neither a College spokesperson nor Farrell and Ferreras provided a reason for leaving. In 2019, Khurana did not reappoint the Deans of Winthrop House for another term following a Crimson investigation which found they were fostering a toxic culture.

When asked how the College plans to prevent instances of mismanagement and hold its faculty deans accountable, Khurana emphasized the importance of the internal system.

“The College continues to work with faculty deans, resident deans and internal staff to ensure students have a wonderful experience,” Khurana said.

Another stress test for Harvard’s house system is the rise in the number of students living in overflow housing. With the exception of Leverett, the upper classes of 11 of the 12 houses reside in overflow housing due to the unprecedented size of the Class of 2025 and ongoing home renovation projects.

Khurana said the College made a “values-based” decision in choosing to admit the same number of students despite a high number of postponements from the Class of 2024 during the Covid pandemic.

“We tried to be very clear about the consequences of this, which would be a surge of students going through the residential system,” Khurana said. “Our residential system was already strained due to house renewals, but we still felt it was important to bring students to campus. »

Still, some students in overflow housing have expressed concerns about feeling disconnected from home life and having to walk longer distances to get to dining halls.

“We hope the continued focus on house renewal and other ways to strengthen and expand the house system will help ease some of the pressure in the years to come,” Khurana said. “But it’s an ongoing challenge.”

Khurana said College administrators should focus on encouraging students to stay connected to their homes through activities such as study breaks and intramural sports.

“It’s embedded in our philosophy that the home system is really essential,” he said.

The Crimson interviews Harvard College Dean Rakesh Khurana once a month during the academic year. Click here submit a question for consideration at our next interview.

—Editor Vivi E. Lu can be reached at vivi.lu@thecrimson.com. Follow her on Twitter @vivielu_.

—Editor Leah J. Teichholtz can be reached at leah.teichholtz@thecrimson.com. Follow her on Twitter @LeahTeichholtz.

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FDA Drafts Guidance on Device Production and Quality System Software Assurance https://mps2016.org/fda-drafts-guidance-on-device-production-and-quality-system-software-assurance/ Mon, 12 Sep 2022 20:58:17 +0000 https://mps2016.org/fda-drafts-guidance-on-device-production-and-quality-system-software-assurance/ Regulatory news | September 12, 2022 | By Jeff Craven The United States Food and Drug Administration (FDA) has published draft software assurance guidelines for computer and data processing systems associated with the production of medical devices. The FDA said the draft guidelines are a document for industry and agency personnel to evaluate computer software […]]]>
Regulatory news

| September 12, 2022 | By Jeff Craven

The United States Food and Drug Administration (FDA) has published draft software assurance guidelines for computer and data processing systems associated with the production of medical devices.

The FDA said the draft guidelines are a document for industry and agency personnel to evaluate computer software with “a risk-based approach to establishing confidence in automation used for production systems or quality, and identify where additional rigor may be appropriate”. Additionally, the document describes how stakeholders can validate the software and determine that it is being used appropriately.

The guide will eventually be a complement to the final guide “General principles of software validation” published in January 2002 and supersedes section 6 of this guide, which focuses on the validation of automated process equipment and quality system software.

The agency said that using this IT software risk-based framework would help meet the requirements of 21 CFR 820.70(i), which dictates maintenance schedule requirements for medical equipment under the jurisdiction of the FDA, while assisting manufacturers with assurance activities and ensuring product quality. “The FDA believes that these recommendations will help drive the adoption and use of innovative technologies that promote patient access to high-quality medical devices and help manufacturers keep pace with the dynamic and rapidly changing technology landscape. , while promoting compliance with laws and regulations implemented by FDA,” they wrote.

In the draft guidance, the FDA outlined a computer software assurance risk framework that includes evaluating the intended use of computer software, using risk-based analysis for software that is part of of the production or quality system to identify the right assurance activities based on the level of risk and the creation of a record of the system to document that it is operating as intended.

The FDA makes a distinction in the guidelines between software that is a direct part of the production process and software in support of the production or quality system. The FDA has declared that software is directly part of the quality process or system for the production of medical devices if it is part of the automation process, inspection, testing, or data collection during production ; is used to automate processes, data collection and processing in quality systems or is used in quality system regulation to maintain a quality record.

Software is used to support the process if it is part of the software testing or monitoring system that is directly part of the production or quality system and part of the record keeping automation process, rather than maintain a quality record, the FDA said.

The agency recognized that software may have more than one intended use, which may carry different risks depending on its characteristics, functions and operations within a production or quality system. “The FDA recommends that manufacturers review the intended uses of individual features, functions, and operations to facilitate the development of a risk-based assurance strategy,” they wrote. “Manufacturers may decide to conduct different assurance activities for individual features, functions, or operations.”

Once software has been classified as part of the production or quality system associated with a medical device, stakeholders should use risk-based analysis to identify appropriate assurance activities for the software. This includes identifying “foreseeable” risks to the software and whether the failure could prevent the software from performing as intended, which could impact production or the quality system (process risk) or cause a medical device to fail. injure a patient or user (medical device risk).

“Specifically, the FDA considers a software feature, function, or operation to be of high process risk when its failure to perform as intended may result in a quality issue that predictably compromises safety, meaning a risk increased for medical devices,” the agency said.

High process risks are typically software features, functions, or operations that maintain process parameters; use limited human intervention to measure, inspect, analyze or accept a product or process; correct or adjust process parameters with limited human intervention; issue instructions to a patient or user of a medical device; or automates data that monitors or tracks the safety and quality of a medical device.

While manufacturers can categorize process risks on a high-to-low risk spectrum, the FDA has divided process risk into “high process risk” and “non-high process risk” categories in the guidelines, explaining that the The agency is “primarily concerned with review and assurance for software features, functions and operations that pose a high risk to processes, as failure also poses a risk to medical devices.

When a manufacturer identifies a high process risk in its software, it must determine whether or not the feature, function or operation poses a potential hazard to a patient or user and apply the appropriate assurance activities based on the assessed level of risk. The manufacturer can use risk-based testing to identify appropriate assurance activities “where the management, selection, prioritization and use of testing activities and resources are consciously based on the corresponding types and levels of risk analyzed to determine appropriate activities”.

For example, in high-risk software testing, scripted testing may be more appropriate, while non-high-risk software testing might include unscripted testing using ad hoc testing, error detection, testing exploratory or a combination of test methods.

Manufacturers should also ensure that an appropriate record is created to document that the software feature, function, or operation performs as intended. The proper record should contain the intended use, risk identification, and assurance activities documentation of software functionality, function, or operation.

“Documentation of assurance activities need not include more evidence than necessary to show that the software feature, function, or operation is performing as intended for the identified risk,” the agency wrote. “The FDA recommends that the record retain enough detail about the assurance activity to serve as a baseline for improvements or a point of reference in the event of a problem.”

Orientation project

© 2022 Society of Regulatory Affairs Professionals.

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Group seeks collective effort to promote social justice system in Nigeria https://mps2016.org/group-seeks-collective-effort-to-promote-social-justice-system-in-nigeria/ Sun, 11 Sep 2022 12:43:14 +0000 https://mps2016.org/group-seeks-collective-effort-to-promote-social-justice-system-in-nigeria/ Public Administration and Social Development Consult, a non-governmental organization (NGO), called for collective efforts by stakeholders to strengthen social justice in the country. The Managing Director of Consult, which is committed to promoting social justice, Ms. Margaret Ibeku, made the call during a press conference in Abuja. Ibeku identified lack of awareness and slow administration […]]]>
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Public Administration and Social Development Consult, a non-governmental organization (NGO), called for collective efforts by stakeholders to strengthen social justice in the country.

The Managing Director of Consult, which is committed to promoting social justice, Ms. Margaret Ibeku, made the call during a press conference in Abuja.

Ibeku identified lack of awareness and slow administration of justice as some of the major factors affecting Nigeria’s social justice system.

“One of the primary challenges of social justice in Nigeria is awareness.

“Most Nigerians do not even know which organizations to turn to for redress if their rights have been violated or if they are falling behind in the opportunities that should be available to them.

“The slow justice system made it seem like offenders who violated ordinary human rights had no consequences for their actions,” Ibeku said.

She said that in light of the above, the organization will partner with the Public Complaints Commission (PCC) to organize a first “Social Justice Conference and Awards” event on October 27 in Abuja.

Ibeku, who is the chairman of the National Steering Committee for the Social Justice Conference and Awards, said the inaugural event aims to promote awareness of citizens’ rights, identify the void and bridge the gap to promote the nigerian social justice system,

“This conference will bring together academics, technocrats, civil society, government officials, interest groups, students, cultural and religious interest groups, researchers and private organizations to interact and x-ray current issues bordering on social justice and good governance”.

Ibeku said the conference also covered the issue of oil and gas, internally displaced people, the housing sector and so many other sectors of the economy.

She said while the former Chairman of the National Human Rights Commission, Prof. Chidi Odinkalu, would deliver a keynote speech at the conference, other stakeholders including politicians would be invited to discuss. general elections of 2023.

She said the body would then present its white paper on recommendations to government and other stakeholders to promote social justice in Nigeria.

Ibeku said highlights of the occasion would include presenting awards to government ministries, agencies and departments of private organizations and individuals who had invested so much in social justice in Nigeria.

She urged Nigerians to visit her website www.socialjusticeaward.com to designate the recipients of the different categories of prizes to be awarded that day.

“We are aware that some people, organizations, with or without support, have done their best in the area of ​​social justice, human rights, justice and equity.

“These organizations will be recognized and it will be a very transparent process.

“We call on all Nigerians to participate in recognizing these people and celebrating them in a way that encourages them to do better.”

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The off-depot oil pricing system will remain regulated for now https://mps2016.org/the-off-depot-oil-pricing-system-will-remain-regulated-for-now/ Sat, 10 Sep 2022 01:00:00 +0000 https://mps2016.org/the-off-depot-oil-pricing-system-will-remain-regulated-for-now/ A representative image. KARACHI: Regulations are unlikely to be lifted from the Inland Freight Equalization Margin (IFEM) in the first phase of the government’s oil sector deregulation drive, as it risks excessively raising oil prices in remote areas of Pakistan, The News learned on Friday. The IFEM is an integral part of the ex-deposit price […]]]>
A representative image.

KARACHI: Regulations are unlikely to be lifted from the Inland Freight Equalization Margin (IFEM) in the first phase of the government’s oil sector deregulation drive, as it risks excessively raising oil prices in remote areas of Pakistan, The News learned on Friday.

The IFEM is an integral part of the ex-deposit price structure of regulated petroleum products, which allows prices to remain at par throughout the country.

This mechanism is used to keep prices equalized at depots across the country, regardless of the distance and mode of transport used and the applicable transport cost.

Sources quoting the chairman of the Petroleum and Gas Regulatory Authority (OGRA) said that IFEM would not be deregulated in the first phase, during which ex-refinery prices of petroleum products and the prices of their imports by OMCs (petroleum marketing companies) would be deregulated.

“Government cannot afford to deregulate IFEM as it would massively drive up the price of diesel and gasoline in remote areas of Gilgit-Baltistan, Azad Jammu & Kashmir, tribal areas and some parts of Balochistan,” a source said.

“There are eight freight zones and if IFEM is deregulated, the price of diesel and petrol could rise by Rs 16 per liter based on the price level existing in the remote parts of the country. compared to others.”

A federal government with a narrow majority could not afford to draw any fire from elected representatives in remote constituencies, because deregulation would raise oil prices in those areas higher than their rates in major cities and places near depots. .

After deciding to deregulate the oil sector, the government asked the OGRA (Oil & Gas Regulatory Authority) to define the terms in consultation with oil refineries and marketing companies. OGRA held its first consultative meeting with stakeholders in the petroleum sector on Tuesday to solicit their input. It will hold another meeting on September 12.

Topline Securities, in a research report, said it had been considered several times before, but no progress had been made due to political pressure and the risk of rising petroleum product prices.

“Given that there are many complexities involved, it is likely that the government will opt for phased deregulation this time around, where a single component of the price of gasoline such as the WTO margin or the ‘IFEM is deregulated, then it is finally completely deregulated,’ the report said.

Currently, gasoline, diesel, kerosene and light diesel are regulated, while high octane gasoline (high quality gasoline) and heating oil are deregulated.

“If the government implements this policy of deregulation, CMOs would be free to set their own prices on a competitive basis instead of pursuing fixed margins or ex-refinery prices set by the government. That said, oil prices would differ based on an area’s distance from the port or refinery and based on the import price per OMC.

The report also pointed out that this would be in contrast to the existing mechanism, where prices were uniform across the country through the use of the IFEM. “Currently, OMCs and dealer margins are also fixed in terms of rupees for one year by the government, which will be in the hands of OMCs to decide after deregulation, in our view,” the Topline report added.

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