Risk Management, Clinical Trials, Ethics and Quality in GSK3
Added on 2021-02-19
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Risk Management, ClinicalTrials, Ethics and Quality
Table of ContentsINTRODUCTION...........................................................................................................................3MAIN BODY...................................................................................................................................31. Describe the clinical trials usually required for the introduction of a new product andcompare this to the clinical trials actually conducted by GSK...............................................32. Discuss GSKs decision to market Strimvelis including:...................................................5Why GSK decided to market the product knowing that the market size is small..................5Information about GSK Pricing policy and the ethics surrounding this decision..................5Researching the average cost of clinical trials for pharmaceutical companies and estimatingthe Return on Investment for GSK (if any) based on market size and pricing policy...........63. Identification of risks and risk mitigation..........................................................................64. Elements of Quality management system (QMS) and importance....................................7CONCLUSION................................................................................................................................8REFERENCES..............................................................................................................................10
INTRODUCTIONClinical trial refers to investigations in which people volunteer to study new methods oftreatments, interventions or tests in order to prevent, treat, detect or manage different healthproblems. It includes various research programmes that are carried out regarding benefits ofvarious drugs, drug combinations and fresh methods of surgery (Soelberg Sorensen, 2017).However, these investigations are helpful to apply more effective as well as efficient treatmenttechniques in regards to increase patient outcomes. This assignment is based onGlaxoSmithKline plc (GSK) which is known as a British multinational pharmaceutical companyto provide effective products for welfare of people. The present report will focus on comparisonbetween usually required clinical trials to actually conducted trials by GSK. It will also includesdecision to market in Strimvelis including pricing policy of and ethics. The identification of risksand quality management system is given below. MAIN BODY1. Describe the clinical trials usually required for the introduction of a new product and comparethis to the clinical trials actually conducted by GSKClinical trails can be described as number of research investigations in terms of analysingbenefits of specific drug to treat or prevent particular health problem properly. It is necessary toconduct proper trials in order to thorough study about benefits and side effects of a drug or drugcombination. Usually, clinical trails are required to be done on humans due to which they areknown as human clinical trials. However, these investigations are helpful to understand theeffectiveness of particular product to make sure about its suitability to make people well-being.In addition to this, it is mandatory to ensure appropriate use of selected drug to avoid the extremecomplications in medical condition of a person (McMillan and et. al., 2017). Moreover, ensuringthrough clinical trails is significant to get approval from authorised agencies for launching newmedication product in market with extra and effective benefits for gaining wellness of anindividual. ComparisonGenerally required clinical trials: This includes the criterion of conducting clinicaltrials on human by putting appropriate amount of time and cost to gain accurate findings. Itincludes to design clinical trails according to specific vaccine and related health problem.
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