Ways of applying operational risk management in banks

The banking sector should rank foremost among the many sectors of the economy that have undergone drastic changes in the last couple of decades or so. The convergence of two colossal factors – globalization and the development of technology – has made inroads into the banking sector, impacting it with a force that was seldom seen earlier.

The number one area of the banking sector to be affected by these changes is operations. Many factors such as credit, software, etc. need to be regulated for their risks. However, the core of the banking sector is operations. Because of this, operational risk management in banks is the highest priority for banks.

The Basel Accords

risk-operational

 

The primacy of operational risk management in banks can be understood from the fact that one of the most important regulations aimed at the banking sector, the Basel Accords, a series of plans to regulate the banking sectors around the world; has operational risk management in banks on top of its agenda. Operational risk management in banks is one of the four areas identified at the second of these conferences, Basel II, the others being regulations concerning capital allocation, disclosure requirements and regulatory arbitrage.

operationalRiskManagementInBanks

Operational risk management in banks according to Basel

The Basel Accord takes a very comprehensive view of operational risk. It describes operational risk as loss that can occur from a variety of reasons, all of which are linked to the core banking structure. The Basel Accord sees risk as something that can happen from any of the operations concerning the bank. It requires operational risk management in banks to take all of these factors into consideration before arriving at solutions to prevent loss from these operations.

pentaho

From the Basel Accords perspective, operational risk management in banks need to take into consideration the following events and identify all of these in identifying frauds and losses:

Internal fraud

Any fraud from any of the bank’s employees, insider trading, false reporting of profits are among the kinds of activities listed by Basel as being part of internal fraud.

External fraud

External fraud can happen from a number of sources. It could be robbery, burglary, hacking of security systems or check bounce. These are part of operational risk management in banks.

Employee fraud

Employees can be a major source of bank fraud. Steps towards mitigating actions from employees that endanger the functioning of the bank constitute a major step in operational risk management in banks.

Other kinds of frauds

Operational risk management in banks has to also take other sources of fraud. These can be from wrong entry of accounts, improper documentation for credit or loans, etc.

Ways of applying operational risk management in banks

Basel II has suggested methods which banks can take to apply risk management in their sector. These include:

operationalRiskManagementInBanks

Advertisements

FDA Releases New Guidance to Advance Digital Medical Tech

Digital tool use is growing, and rapidly. To keep up with these changes, the Food and Drug Administration released a Digital Health Innovation Action Plan over the summer. It aimed to redesign medical device regulation to effectively address new tools, while also making way for innovation in the field.

The FDA quickly followed up the plan with several initiatives, including the launch of its Digital Health Software Precertification Pilot Program, which looks to fast-track the development and uses of digital health technologies. The FDA chose nine companies to participate in the program in September, including Fitbit, Samsung and Apple, among others.

Now, to close out the year, the agency has released three policy documents that will shape future health IT oversight and innovation.

“We recognize that our regulations play a crucial role in the efficient development of such technologies. Therefore, our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation,” FDA Commissioner Scott Gottlieb said in a statement. “Moreover, we must always lean in the direction of enhancing access to more information — not restricting information flow — given the ability of reliable information to positively impact daily life.”

Aside from encouraging innovation, the three new guidances — two drafts and one final — also address key provisions of the 21st Century Cures Act that seek to lay out the FDA’s role in digital health — where it is needed and where it is not.

These three new guidances include:

A Clarifying Look at Clinical Decision Support Software

As the pool of health data grows thanks to technologies such as wearables that collect data on everyday activities, the need to sift through data and use it to create actionable insights is rising. Backed by machine learning, clinical decision support (CDS) software aggregates and digests healthcare data to help inform or support clinician decisions on treatment options, diagnostic tests and more.

“This type of technology has the potential to enable providers and patients to fully leverage digital tools to improve decision-making,” Gottlieb said. “We want to encourage developers to create, adapt and expand the functionalities of their software to aid providers in diagnosing and treating old and new medical maladies.”

The FDA hopes to do this by releasing a new draft guidance that will clarify which types of CDS will not qualify as medical devices, and therefore not fall under FDA regulation.

Essentially, the guidance outlines that CDS or similar patient decision support (PDS) software that allow the clinician to “independently review the basis for the recommendations” will not fall under FDA guidance. Software that analyzes or processes “images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram” and uses these analyses to make treatment recommendations will fall under FDA oversight.

Enhanced here to continue for the full article http://snip.ly/g6y0z

Biocompatibility testing and evaluations for medical devices

Biocompatibility testing and evaluations for medical devices is a vital component of patient safety, for it is the only effective means to ensuring that a medical device or any related material, when it happens to come into contact with the patient’s body has to not only perform its intended purpose and function; it should also not result in adverse reactions for the patient.

When medical devices and/or materials come into contact with the patient’s body, they can cause problems or what may be termed adverse effects that can be either short-term or long-term adverse effects to the body. These effects, called acute to chronic, can result in mutagenic effects. It is to prevent the occurrence of such events that biocompatibility testing and evaluations for medical devices has to be carried out.

These evaluations for biocompatibility of medical devices are done to evaluate the interaction between a device and anything it comes into contact with within the patient’s body, such as cells, tissue or body fluids. Essentially, device biocompatibility is assessed to prevent biological risks from happening to the patient.

ISO standard for biocompatibility testing and evaluations for medical devices

The International Standards Organization (ISO) has a specific standard for carrying out and ensuring biocompatibility testing and evaluations for medical devices. It is called ISO 10993-1: 2009, and makes biological evaluation part of a structured biological evaluation program that comes under a risk management process. All these are carried out in accordance with ISO 14971.

ISO 10993-1, Biological Evaluation of Medical Devices – Part 1 The basis for biocompatibility testing and evaluations for medical devices is the Risk Management Process. This is the most prevalent standard for assessing biocompatibility testing and making evaluations for medical devices. In requiring biocompatibility testing and evaluations for medical devices to be conducted in compliance with Principles of Good Laboratory Practice (GLP) and/or ISO/IEC 17025 and requiring the consideration of evaluation of local and systemic risk factors; the ISO 10993-1 is considered the basis for determining the subsequent, necessary biocompatibility testing and evaluations for medical devices.

What factors are tested? In line with the principles set out in ISO 10993-1: 2009 on biocompatibility testing and evaluations for medical devices, specific testing is prescribed based on two factors: a) the type and the intended use of a medical device or related material, and b) the kind, tenure and extent of contact the medical device makes with the body.

ISO 10993-1: 2009 on biocompatibility testing and evaluations for medical devices requires assessment to be made for the following among others:

  • Cytotoxicity
  • Genotoxicity
  • Sub chronic toxicity
  • Sensitization
  • Irritation or intra-cutaneous reactivity
  • Implantation
  • Haemocompatibility
  • Systemic toxicity, etc.

Antibiotics sales for use in U.S. farm animals dropped in 2016: FDA

CHICAGO (Reuters) – The sale and distribution of antibiotics approved for use in food-producing animals in the United States decreased by 10 percent from 2015 to 2016, a U.S. Food and Drug Administration (FDA) report said on Thursday.

It was the first decline in year-to-year sales since the FDA began collecting the data in 2009, according to food and consumer health groups.

For years scientists have warned that the regular use of antibiotics to promote growth and prevent illness in healthy farm animals fuels dangerous, antibiotic-resistant “superbug” infections in people.Major U.S. food companies including McDonald’s and Tyson Foods have stepped up efforts to curtail, and in some cases eliminate, antibiotics in their products.

“Actions speak louder than words, and the most action we’ve seen on antibiotics has come from food companies,” said Matthew Wellington, Antibiotics Program Director of public interest campaigning group U.S. PIRG. “We’re cheering this good news.”

Last month, the World Health Organization urged farmers to completely stop using antibiotics to enhance growth and prevent disease in healthy animals.

An estimated 70 percent of the kinds of antibiotics that are also used to fight human infections and in surgery are sold in the United States for use in meat production.

In 2016, sales and distribution of those medically important antibiotics for food production fell 14 percent, the FDA said.

Medically important antimicrobials accounted for 60 percent of the domestic sales of all antimicrobials approved for use in farm animals in 2016, the agency said.

The FDA’s data show chicken accounting for 6 percent of medically important antibiotic sales, with swine at 37 percent and cattle at 43 percent.

Click and follow for full article http://snip.ly/fc19r

FDA’s program to speed up drug approval shaved nearly a year off the process

Speeding the pace at which potentially lifesaving drugs are brought to market was a rallying cry for Donald Trump as a candidate, and is a stated priority of his Food and Drug Administration commissioner, Dr. Scott Gottlieb. But a new study finds that programs already in place were routinely shortening the drug development process by close to a year, and sometimes much more.

Shorter drug-development timelines hold the promise of getting new medications to suffering patients more quickly. But when it comes to getting a drug candidate through clinical trials and FDA review, time is also money. Faster approval means drug companies can begin profiting more quickly from their discoveries. And that may (or may not, according to whom you talk to) result in lower drug prices.

In a Research Letter published Tuesday in the journal JAMA, a trio of health economists from Brigham and Women’s Hospital in Boston set out to test whether and how four FDA programs shortened the length time it took for proposed prescription drugs to get from their earliest clinical trials to market approval.

Of 174 drugs and biologic therapies approved between January 2012 and December 2016, 105 (or 60%) traversed the FDA evaluation process with one of four designations aimed at speeding the path to approval. The 69 candidate medications that had no such hurry-up designations took between 6.5 and 10 years to proceed from the start of human trials to FDA approval, with a midpoint of eight years.

Candidate medications evaluated under one of the four accelerated programs took between 5.1 and 10.1 years to cover the same ground, with a midpoint of 7.1 years.

Those faster speeds were largely attributable to two programs.

One, instituted in 2012, compresses clinical trials, dedicates FDA personnel to provide advice, and streamlines the FDA evaluation process for experimental drugs that may provide “breakthrough” therapy for a disease. Half of the drug candidates that got the breakthrough designation sprinted from the start of human clinical trials to FDA approval in 4.8 years or less, compared with a median start-to-finish time of eight years for drug candidates with no expedited designation.

Click here to company http://snip.ly/t33k6

Potentially deadly drugs stolen in Perth vet break in

A thief who broke into a Perth veterinary hospital may not know one of the drugs they stole is used to euthanise pets, WA Police have warned.

The Forrestdale veterinary hospital was broken into at around 2.15am on Monday morning, and a large quantity of drugs were stolen.

The thief made away with Lethabarb, Apomorphine, Propofol, Alfaxan, Diazepam, Zoletil, Antisedan, Dozadine and ACP.

While a number of drugs the thief took are used as general anaesthetic or sedatives, WA Police warned the thief against taking anything they had stolen.

“The person(s) who stole the drugs may not fully appreciate the dangers associated with veterinary drugs,” police spokeswoman Susan Usher said.

Diazepam is a type of valium while Profpol and Alfaxan are used for general anaesthetic and can be dangerous for human consumption.

Apomorphine also has a peculiar effect on humans, including induced vomiting and potentially causing an erection in males.

However, police are most concerned about the thief taking Lethabarb from the hospital.

Here to go for discontinued article http://snip.ly/0xo8z

Who oversees the trial, has to undertake to the FDA

A vital document required when carrying out a clinical trial is FDA Form 1572 Statement of Investigator. It is a contract between the Principal Investigator (PI) and the FDA. FDA Form 1572, or just 1572, has all details of the subjects in the research, as well as the commitments the PI, who oversees the trial, has to undertake to the FDA. This commitment concerns meeting all the requirements from the FDA as they relate to the trial.

When the PI signs the FDA Form 1572, which relates to IND studies, or the “Statement of the Investigator, which is meant for IDE studies; she undertakes a commitment that she will comply with all the appropriate regulations and will be liable to facing legal action in the event of failing to do so. Hence, the FDA Form 1572 is a strongly legally binding document which sets out the terms of the commitment between the PI and the FDA.

The FDA has created the form 1572 with two main intentions:

It aids the FDA in gauging the PI’s suitability for overseeing the study, as it requires the latter to declare criteria related to this, such as experience and qualification. It also helps it understand the purpose of the study and the suitability of its methods to help it achieve its aims. Not only the FDA, but also the sponsor of the study can get this information from the form 1572.

Additionally, the FDA Form 1572, by taking an undertaking from the Principal Investigator that she will meet the requirements set out by the FDA during the trial; criminalizes the failure on the part of the PI to meet these conditions. It treats this as giving false statements, which empowers the agency to proceed legally against the PI under 18 USC 1001. When the sponsor selects the Principal Investigator to conduct a clinical trial as an investigational new drug (IND) that meets the criteria set out in 21 CFR 312.53 (c); this form has to be submitted.

Other documents accompanying the 1572

In addition, the following documents, which set out the general and specific responsibilities that the Investigators have when conducting a clinical trial; have to accompany the FDA Form 1572:

  • 21 CFR 312.50: contains the General Responsibilities of Investigators
  • 21 CFR 812.100: sets out the Responsibilities of Investigators for Biologics
  • 21 CFR 812.110: details the Responsibilities of Investigators for devices.

Get to understand the workings of FDA Form 1572

With the FDA Form 1572 being of crucial importance, compliance with it is not something that a sponsor or a PI can take lightly. Meeting the regulatory requirements set out in this document is in the interest of everyone concerned.

It is with the purpose of familiarizing the aspects relating to FDA Form 1572 that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing a webinar.

The speaker of this webinar, Charles H. Pierce, a consultant in the Clinical Research/Drug-Device Development arena, will offer insights into the nature of the due diligence that investigators and their staff have to take in meeting their regulatory and legal responsibilities.

Please register for this highly educative webinar by visiting Form FDA 1572 Seriously

FDA Form 1572 contains nine statements, seven out of which begin with “I agree”. Some of the essential elements named in the 1572 include:

  • 21 CFR 50 (Protection of Human Subjects)
  • 21 CFR 56 (Institutional Review Boards)
  • 21 CFR 312 (Investigational New Drug Application/IND)
  • For Device studies, 21 CFR 812 (Investigational Device Exemptions/IDE) is added in place of 21 CFR 312.

Also, additional responsibilities are outlined in GCP Guidelines of E6 (4) and the Compliance Program Guidance Manual (CPGM) 7348.811. In addition to complying with the principles of Good Clinical Practices (GCP); the PI and sponsors are advised to also use their discretion.

At this session, the speaker will offer complete clarity on these aspects. The following areas will be covered at this webinar:

  • The Investigators role in the clinical research process
  • The difference between AEs and SAEs and the reporting requirements of the investigator
  • Why the investigator maintains a list of staff signatures?
  • Why the investigator files the signed and dated protocol?
  • Why the investigator is responsible for the IC process?
  • What is the legal language of the FDA Form 1572 or Device equivalent?
  • Why is Financial Disclosure information important?
  • What is the history of the drug / device regulations?

For updates from this please https://goo.gl/forms/SNAcsW8rLKPrzxLD2