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Select a therapeutic area (eg cardiovascular, oncology etc) and create a comprehensive project plan for a drug to be developed in this area. In this plan, identify the four phases of drug development, the approximate number of patients/subjects to be included in each phase and the purpose of each phase. Identify the operational steps (what you need to do) in taking the drug through each phase and what training you would provide the sites so that they would know what their responsibilities were as regard to GCP’s.

Emergency preparedness and response plan For an effective emergency preparedness and response plan to be executable, various parameters need to be considered. In addition to the legalities involved, there are many considerations that need to be asserted to . They include different parameters like the assessment of the health risk, the legal attributes under operation, the roles and responsibilities to be carried out, along with a command system .these need to be integrated with other features like public engagement, laboratory and epidemiological functions along with counter measures, research, migration, robust supply, migration strategies etc. These methodologies need to be applied and executed for a suitable response plan((Nelson et al., 2007).The benchmarks for this plan has been discussed by WHO(. Benchmarks, Standards and Indicators for Emergency Preparedness and Response ,2007). In the given plan, titled “South Central Ohio Regional Public Health Emergency Response Plan. 2015,” the plan appears to b very well thought out and constructed with the optimum inclusion of the different parameters as discussed in the initial stages of this communication. As the program i an interactive endeavour of a primary Ross Country Health District being supported by numerous secondary bodies like American Red Cross, Adena Regional Medical Centre, SEO Epidemiologists, Ross County Coroner. Local Veterinarians to name a few./’ For functionality, the plan under consideration has been subdivided into the Ross County Emergency Response Plan (ERP)/Emergency Support Function-8 (ESF-8), Public Health and Medical Services and they are integrated and interact in a coordinate


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