Clinical safety information is one of the important factors, through which the management take proper actions to minimise the effect on the treatment. Necessary information has to be gathered for improving or introducing good and effective clinical practice standards. Experts ensure to gather the required information through which the periodic safety measures are updated on a regular basis. The guidelines required for improving the regulations and practices along with the time frames has to be analysed and introduced. Clinical safety information is necessary, as it helps the experts to introduce the right steps through which the changes can be introduced. The medical products that are under development have to be checked at the earlier stage. This has to be done before implementing the marketing strategies. Medicinal products undergoes through different development process and the same needs to be evaluated. For this, safety data needs to be collected and analysed by the experts. In this process, the rules and regulations imposed by different countries has to be followed. The rules differ and depend upon the complex or the nature of medicines (Adverse Event Reporting, 2005). Some of the issues that are associated with the process of medical development include -
1. Introducing standard definitions or terminology for developing or harmonization of the medicines.
2. Introducing an effective and reliable clinical safety reporting system. It also includes introducing mechanism that would help in investigating and conducting the research work (Ceh, 2009)
The terms and definitions used for medical terms are quite important and the same needs to be understood in the right manner. Through this process, the positive and negative aspects associated with the product development can be analysed. Pharmacovigilance harmonization is associated with analysing the situations that involves in the clinical investigation. The modification regardless of the nature has to be considered. This is required for accommodating the development environment and pre-approval of the medicinal development process (Careb Ae Guidance, 2010).
Safety data for medical purposes are collected for the below mentioned factors –
1. Controlling the adverse events, which is related to the medical development
2. Analysing the serious adverse events associated with the medicinal developmental process.
3. Collecting and analysing data for laboratory and project data that is required for conducting the research for the medical development purposes (EMEA, 2002).
Sources adopted for analysing the details PR the information that is collected by the experts for conducting the medical research has to be spontaneous. This would also include implementing rules for the legal guardian that is related to the member involved in the study or the research work. With the help of the non-directive and or open questioning method, it is possible to gather and analyse the essential information that is associated with the research for the medical development. The role played by the investigational team like the physical examiners, different type of tests, and others are also included in the process. In the AE process, collecting the dairy cards and analysing the electronic agendas has to be evaluated (Kabanywanyi et al., 2010).
In the clinical safety issues the factors associated with the drug development needs to be reviewed thoroughly. Through this process, appropriate action plan can be planned and implemented by the experts. The safety of the patients and the volunteers has to be analysed. For this, the on-going factors has to be done after analysing the below mentioned factors –
The occurrence of the medical uncertainty can affect the clinical investigation process. Thus, the corrective measures for improving the pharmaceutical product manufacturing have to be introduced. In this case, the occurrence of the unfavourable incidence has been analysed. This would help in improving the quality of services that is intended to be provided to the people. Through this process the symptoms and disease nature can be analysed. This would help in rendering the best services to the people.
It is essential to identify the signs or symptoms that can affect the health of the people. In case of moderate factors the discomfort factors that can interfere with the usual activity has it be identified. Severity of the medical problem is related to incapacitating the inability of the individual to perform the tasks, which also includes usual activities (EMEA, 2002).
Adverse Event Reporting, 2005. Standard Operating Procedure Number: 3-2. Page 1-6. Viewed on 6th March, 2015. Retrieved from https://ahc-sharepoint.uc.edu/hrp_policies/Clinical%20Site%20SOP%20Templates/3%20-%20Unanticipated%20Problems/SOP%203-2%20Adverse%20Event%20Reporting%20final.pdf
Ceh E, 2009. Journal of Clinical Research Best Practices. Vol. 5, No.3. Viewed on 6th March, 2015. Retrieved from https://firstclinical.com/journal/2009/0903_Adverse_Prep.pdf
Careb Ae Guidance, 2010. Canadian Association of Research Ethics Boards Guidance on Reporting of Unanticipated Problems including Adverse Events to Research Ethics Boards in Canada. Viewed on 6th March, 2015. Retrieved from https://www.careb-accer.org/sites/default/files/uploads/en/Recently%20Filed%20Comments/CAREB%20Guidance%20-%20AE%20Reporting%20-%20July%202010.pdf
EMEA, 2002. European Medicines Agency. Viewed on 6th March, 2015. Retrieved from https://ethikkommission.meduniwien.ac.at/fileadmin/ethik/media/dokumente/rechtsgrundlagen/GCP.pdf
Kabanywanyi A, Mulure N, Migoha C, Malila A, Lengeler C, Schlienger R, and Genton B, 2010. Experience of safety monitoring in the context of a prospective observational study of artemetherlumefantrine in rural Tanzania: lessons learned for pharmacovigilance reporting. Viewed on 6th March, 2015. Retrieved from https://www.biomedcentral.com/content/pdf/1475-2875-9-205.pdf
Zongo I, Dorsey G, Rouamba N, Tinto H, Dokomajilar C, Guiguemde RT, Rosenthal PJ, and Ouedraogo JB, 2007. Artemether-lumefantrine versus amodiaquine plus sulfadoxine-pyrimethamine for uncomplicated falciparum malaria in Burkina Faso: a randomised non-inferiority trial. Lancet 2007, 369:491-498
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