Risk management methods and tools in the pharmaceutical and life sciences industries

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Understanding and implementing risk management methods and tools is crucial for the pharmaceutical and life sciences industries in view of the fact that errors in this area can lead to dangers for human life. Since any mistake in any chain of in this industry can lead to serious consequences; the FDA and other regulatory agencies have created a number of risk management methods and tools for these industries.

A few commonly used risk management methodsIn the pharmaceutical and life sciences area, a few commonly used risk management methods and tools for organizing data and using these to help in decision-making include the following:

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A few popular risk management methods and toolsIn the field of pharmaceuticals and life sciences, these can be said to be some of the more popularly used risk management methods and tools:

Failure Mode Effects Analysis (FMEA)FMEA is a popular one among the risk management methods and tools mainly because it provides a methodology for assessing a potential failure mode for the process that goes into the manufacturing of the pharma or life sciences product and helps to analyze their possible impact on the product’s ability to perform to its required standard.

risk-in-pharmaceutical-and-life-sciences-industriesIdentification and establishment of failure modes are taken as the basis for using risk reduction techniques for eliminating, containing, reducing or controlling the possible failures. Since FMEA depends on a deep understanding of the product and the process; its main steps include dissembling complex processes into simpler and comprehensible ones. For this reason, FMEA is considered a potent risk management method and tool.

Failure, Mode, Effects, and Criticality Analysis (FMECA)Extending the concept of FMEA a little farther, the Failure, Mode, Effects, and Criticality Analysis (FMECA) takes into account the added feature of the extent of gravity of the consequences of a fault or failure, along with the possibility of their occurrence, as well as the chance of their detection. While this is the slight extension that the FMECA brings to FMEA; it is similar to it in other respects, namely:

risk-in-pharmaceutical-and-life-sciences-industriesFMECA too, like FMEA, uses identification and establishment of the process specification to identify risks and failures

FMECA too uses the method of breaking down difficult processes to easier ones to enable better understanding of the failures and risks.

Fault Tree Analysis (FTA)Fault Tree Analysis is another of the risk management methods and tools. What this tool does is that it takes up a single fault at a time for analysis, but links the chains that cause the fault. This is why it gets its name, wherein the results of the analysis are represented in a shape of a tree, in which each level of fault is described with possibilities. A sharp and incisive analytical bent of mind is required to create the FTA.

Hazard Analysis and Critical Control Points (HACCP)HACCP is yet another important one among the risk management methods and tools. It takes a systematic and proactive approach in ensuring the following in a product:

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It is considered a comprehensive risk management method and tool because it addresses all the issues relating to risk management methods and tools, applying scientific principles and methods for carrying out the following:

risk-in-pharmaceutical-and-life-sciences-industriesControlling of the risk or the negative outcomes of hazard, which could be due to any of these:

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Supporting statistical tools
risk-in-pharmaceutical-and-life-sciences-industriesWhile all the risk management methods and tools described above are a snapshot of some of the major ones, a few supporting statistical tools, too, are used to engender quality risk management. These are some of them:

 

 

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200+ followers. WOWWWWWW…

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Hello Everyone,

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

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Digital Marketing for Pharmaceutical companies offers tremendous opportunities

There is enormous potential for digital marketing for pharmaceutical companies. Proper exploitation of the social media can take pharmaceutical companies to their market in a more pinpointed and accurate manner than traditional marketing.

Gone are the initial days of reluctance on the part of pharmaceutical companies to embrace social media as a powerful marketing medium. That was in the past, when the concept of social media was new, and regulations in the pharmaceutical industry had yet to catch up with explosive pace at which the social media grew.

More and more pharmaceutical companies are on the social media

Today, one is likely to see any pharmaceutical company worth its name being active on YouTube, Facebook and Twitter to interact with its customers. Changes brought about by digital marketing in the pharmaceutical industry have seen companies like Johnson and Johnson and Pfizer being among the several majors associated with YouTube lately for creating and promoting their image. This is a result of the realization that social media can, far from being unconducive to the industry, can be quite amiable to it.

  • In a study in late 2014, the New England Journal of Medicine estimated that leading pharmaceutical companies spend up to a quarter of their marketing budgets on the social media
  • The study pointed out that the social media were as powerful and effective as EHRs and mobile applications as marketing tools, signaling a new dynamic for digital marketing in the pharmaceutical industry.

Social media as a key differentiator

The defining area in which the social media can be different and more effective than traditional marketing tactics for pharmaceutical companies is this: earlier methods such as trade conferences, promotions, gifting doctors for prescribing a company’s brands were effective, but were carried out outside the healthcare setting and in isolation of the patient. The reach and intervention of the social media has made digital marketing for pharmaceutical companies so much more effective that they can get right into the arena of treatment and be of assistance with valuable inputs and suggestions.

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Data Mining and Signal Detection in Pharmacovigilance

Data Mining and Signal Detection in Pharmacovigilance

A signal is described by the World Health Organization as any information that is reported on a possible or potential causal relationship between a drug and the adverse event it spawns. This relationship can be of virtually any nature, so long as it concerns the drug and the subject, and it could be either new or one with a precedent.

Data mining can be described as the method of obtaining data from target groups to help the clinical study come to important assessments and conclusions. Many a time, it is not clear whether a drug’s expected benefits outweighs the potential risks it brings about or vice versa, till the drug goes for marketing authorization. In order to assess this to the extent possible, clinical pharmacologists weigh the benefit and risk evaluation of medicines using tools such as data mining. Data mining is done both at the individual level of a subject and at the macro level of the population at large. These two methods are usually inseparable from each other, in that almost no study is done exclusively for one group.

Given its ability to help pharmacologists discern the various patterns that emerge from a clinical study; data mining is acquiring a position of importance of late and is being used in almost all stages of drug development. This could range from the earliest stage, namely drug discovery and could go up to post-marketing surveillance.

The WHO’s Uppsala Monitoring Centre

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In order to make the results of very clinical study done in every part of the world accessible to everyone – a formidable task without doubt – the WHO has formulated the Uppsala Monitoring Center. This is a universal database of all the results obtained from clinical research the world over. Although voluntary and missing data from a many studies; the UMC is a comprehensive attempt at establishing a data mining and signal detection system that is accessible to everyone concerned. The UMC can thus be considered the universal data mining and signal detection database.

With over 2.5 million case reports of various clinical studies done all around the world, the UMC has evolved over time as a data mining and signal detection database. It initially started by requiring principals of clinical studies to generate new drug and Adverse Drug Reactions (ADR) combinations every three months. With the growth in the number of studies and the variety of issues they threw up; this was no longer considered feasible.

The UMC then started out to create its own method, by which the principles of making an objective initial assessment of all new drug and ADR combinations started getting implemented as they emerged. To this were added the requirements of bringing about a transparent selection of drug – ADR combinations for review, as well as suggest a quantitative aid to data mining and signal detection.

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Today, the UMC uses several methodologies to carry out its task of being at the forefront of data mining and signal detection. It uses the Bayesian Confidence Propagation Neural Network, which uses Bayesian statistics within the architecture of a neural network for data mining and signal detection.

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Biotech and Pharmaceutical Courses are a gateway to a challenging and flourishing career

Biotech and Pharmaceutical Courses are a gateway to a challenging and flourishing careerWith over four million employed directly or in allied sectors and catering to the world’s largest market and research area, biotech and pharma is a fast growing industry. Its courses are designed to prepare individuals for this giant industry.

Biotech and pharmaceutical courses are much sought after by aspiring professionals in the field of biotech and pharma. This is why:

  • The US is the world’s largest market for pharmaceuticals, as well as being the world leader in biopharmaceutical research
  • Research by Pharmaceutical Research and Manufacturers Association (PhRMA) has revealed that the majority of the world’s research and development (R & D) in pharmaceuticals is conducted by U.S. firms
  • These firms hold the intellectual property (IP) rights on most new medicines.

Huge in every sense

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Around 5,000 new medicines with approximately 3,400 compounds are currently being studied in the United States, the longest pipeline in any region in the world. The pharmaceutical industry employs nearly a million people and supports more than three times that number in related and supplementary industries. All these place a high demand on biotech and pharmaceutical courses.

What should those aspiring for courses look for?

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Certification is the primary criterion to look out in those seeking a biotech and pharmaceutical courses. Whether it is classroom or online courses that are opted for; certification by a certifying authority should be the determining admission to biotech and pharmaceutical courses.

CFPIE or the Center for Professional Innovation and Education Inc., BioPharma Institute and Center for Professional Advancement (CFPA) are some of the better known providers of certified biotech and pharmaceutical courses. This is a partial list of the areas on which courses are offered by these institutes/centers:

The following tripod of software-related issues forms the IEC 62304:2006’s foundation:

biotechandPharmaceuticalCoursesThese three attributes form the backbone of the test of a medical device company’s successful compliance with the regulatory requirements. For a medical device company to be successful in applying ISO 14971:2012 and IEC 62304:2006; it has to implement a cross-standard and resourceful way of integrating activities covering these requirements documents.

 

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Thousands of drugs at risk if no Brexit deal, European pharmaceutical companies warn

Brexit threatens the free flow of these goods, given stringent medicine regulations that may require the retesting of drugs shipped across borders in the absence of an agreed trading arrangement.

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Supplies of thousands of medicines are at risk of disruption if Britain leaves the European Union without a trade deal, European pharmaceutical companies warned on Thursday. More than 2,600 drugs have some stage of manufacture in Britain and 45 million patient packs are supplied from the UK to other European countries each month, while another 37 million flow in the opposite direction. Brexit threatens the free flow of these goods, given stringent medicine regulations that may require the retesting of drugs shipped across borders in the absence of an agreed trading arrangement.

The European Federation of Pharmaceutical Industries and Associations (Efpia) said a survey of its members showed 45 percent of companies expected trade delays if Britain and Europe fell back onto World Trade Organization rules after Brexit. Drugmakers also face an additional hurdle when it comes to licensing their products, since more than 12,000 medicines will require a separate UK licence in order for them to be prescribed. “For life-saving and life-improving medicines, the EU and UK cannot afford to wait any longer to ensure that the necessary cooperation on medicines is in place from the day the UK leaves the EU,” said Efpia Director General Nathalie Moll.

Pharmaceutical companies have insisted since last year’s Brexit referendum that a comprehensive agreement is needed to ensure maximum alignment between EU and British pharmaceutical regulations. But with the clock ticking down to Brexit in March 2019 with no sign yet that a trade deal will be concluded, many companies are now starting to draw up plans to protect drug supply chains, including building extra testing centres in Europe.

 

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Lonza news Tolvaptan identified as a treatment for autosomal dominant polycystic kidney disease

A phase 3 trial studying the effects of tolvaptan has found that the drug slowed the rate of decline in kidney function in patients with polycystic kidney disease…

Tolvaptan identified

A phase 3 trial studying the effects of tolvaptan has found that the drug slowed the rate of decline in kidney function in patients with the most common form of polycystic kidney disease, a condition with no cure.

This is the first treatment that targets a mechanism that directly contributes to the development and growth of the kidney cysts in autosomal dominant polycystic kidney disease

The results of the trial demonstrated tolvaptan’s ability to intervene in a way that slows kidney function decline in this population.

“This is the first treatment that targets a mechanism that directly contributes to the development and growth of the kidney cysts in autosomal dominant polycystic kidney disease,” says Dr Vicente Torres, director of Mayo Clinic’s Translational Polycystic Kidney Disease Center. “This in effect means it may delay the need for a kidney transplant or dialysis in patients with this disease.”

Autosomal dominant polycystic kidney disease is an inherited condition that affects 1 in every 500 to 1,000 individuals in the U.S. This disease is found in all races and sexes. Autosomal dominant polycystic kidney disease, which is the fourth most common cause of end-stage kidney disease, requires dialysis or a kidney transplant.

The disease causes a slow but relentless growth of cysts that damage the kidneys. In addition to negatively affecting the quality of life, the condition also causes hypertension and painful complications. The cysts, which can damage kidneys with their size, can develop in other organs, especially the liver.

Approximately half of individuals with autosomal dominant polycystic kidney disease eventually will require dialysis or kidney transplant by age 60.

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