Ankit Patel- Case Study#1

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Conestoga College *

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8920

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Information Systems

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Feb 20, 2024

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docx

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1 Case Study #1 Patel Ankit Kumar Thakorbhai Regulatory Affairs, Conestoga College MGMT8920: Project Management of Regulatory Affairs Submissions Nadiya Samaroo 23-01-2024
2 Case Study #1 Question One: Briefly describe the COVID-19 global pandemic. On January 12, 2020, WHO announced the invention of a new virus known as the novel coronavirus (2019-nCoV). On February 12, 2020. Since COVID-19 began in China, the virus has rapidly spread to other countries. On March 11, 2020, the WHO announced COVID-19 as a pandemic (Yen-Chin Liu, 2020) . Public servants and Legislators have compulsorily implemented lockdown measures that have influenced the environmental and economic situation, human psychology, and the education system in the world. From an ecological view, transport and mobility reductions have reduced hazardous gas emissions and demand for commercial energy. The health restrictions suddenly put in place create madness among people, the changes in the education system, the reduction of tourist activity, the lay-off of employees, and the decrease in the human budget and the gross domestic product (Youssef Miyah, 2022) . Strategies to address these challenges included: Establishing regular team meetings to develop new solutions. Focusing on a few reliable sources of information. Working in alternating shifts. Increasing telemedicine. Establishing window and open-air practices. Check regular updates on this pandemic. Respondents reprove primary care for not considering their experiences when planning pandemic precautions. Along with that, people should start eating healthy food for better immunity (Marione Eisele, 2021) .
3 Question Two: Explain the risks and complexity of the challenges faced by AstraZeneca to address the vaccine problem related to the COVID-19 pandemic. AstraZeneca faces several issues regarding clinical trials while mitigating the world's most dangerous disease. First, they should get permission from regulatory agencies, such as the US FDA, to monitor and mitigate potential adverse medication reactions. Secondly, firms must manage both activities due to more COVID cases. They should fulfill the requirements of clinical trials; however, they must plan for bigger-scale vaccine production. Public trust and communication because of misinformation and skepticism are the biggest challenges for the AstraZeneca vaccines (Project Management Institute, 2021) . During the cut-throat competition, AstraZeneca needed to increase manufacturing capacity quickly while maintaining Quality, consistency, and adherence to Good Manufacturing Practice (GMP) guidelines. Purchasing components, raw ingredients, and specialized equipment from suppliers throughout the globe is a necessary step in the vaccine manufacturing process. To preserve production continuity, AstraZeneca had to manage intricate supply chains, reduce the risk of shortages or disruptions, and guarantee the availability of essential inputs (Project Management Institute, 2021) . The AstraZeneca Global project and portfolio management function identified three significant gaps during the analysis of the vaccine project. One of them is personnel qualification and experience. Project managers need more experience. Its repercussion is a delay in the project and delays in navigating complex processes and regulatory approval. Finally, they need more support from internal government contracting organizations (Project Management Institute, 2021) .
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