Personal project presentation Case Study Solution
Barriers and solutions
On boarding and managing conflicting interest
Making human vaccines available on the international scale tends to require the complicated and complex use of production and distribution channels, which ensure that the products are effective and potent at their point of use.(Jon Smith, 2011 ). One of the barriers in the vaccine industry on global scale, is the increasing variation in regulations around vaccines ’production and distribution on global scale.
The significant differences in the regulatory requirements for the production and distribution of vaccine, might require manufacturers and distributors to add regulatory and laboratory staff on account of the stringent standards in different countries. Such increased cost might be reflected in the vaccines’ prices. In the vaccine industry; a number of events could catalyze the changes in regulation as well as enforcement; many vaccine products might be made only for particular nation, on the basis of its legislations and regulations, thus limiting inventory’s flexibility and increasing the difficulty for logistics.
The manufacturers are also obliged to comply with the Pre-Qualified requirements of WHO, which ensures the vaccines’ quality, and is highly systematic and structured. A manufacturer needs to comply with the requirements of his national regulatory authority (NRA) & make adjustment to the changes in the regulations, including routine monitoring of data of adverse event, annual report of information related to manufacturing, such as: stability review, change management, data trends, critical investigation of unexpected trends and any process failure. The licensing of the products must be obtained by the country which imports, often requiring nation-specific trial clinics subject to similar compliance requirements, such as: global adverse event reporting and monitoring and routine inspection from those NRA.(Stanley Plotkin, 2017).
The risk and cost to manufacturer related to vaccine production have increased, including an increase in vaccine injury lawsuit, removal of preservation thimerosal and regulation. Additionally, maintaining the interest of producer and stable supply sources of routine childhood vaccines contribute more to a significant challenge. The vaccine markets are dynamically competitive & lucrative with new suppliers, because of thriving nature of industry, increased demand of vaccine products, larger market size and desirable levels of vaccine innovation.(Officials, 2015)………………………………..
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