Ankit Patel- Case Study#1
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Feb 20, 2024
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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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4
Question Three: Discuss the project management infrastructure developed by AstraZeneca
to overcome the challenges identified in Question 2 and the results obtained.
1)
PMO Establishment
- Before the COVID-19 outbreak, AstraZeneca did not have any Project
Management Office (PMO) because they needed those high levels of projects and the
capability of a dedicated office to fulfill the requirements of projects. They are categorized
into four essential functions: Integration of schedule budget, contract management, Team
process guidance, and Risk Management.
2)
Experienced process managers
tackle staffing issues in several ways. First, they hired more
people from their existing 80 project managers team and hired more people with the same
knowledge. Moreover, they include people in the vaccine team who worked for government
contracts and vaccine projects and have good experience. However, they have had difficulty
hiring people during the pandemic. They also employ outside project management by doing
hard work.
3)
Internal government contracting organization-
"It was essential to have a separate office
that could enable the focus on contract deliverables rather than running the project and
managing the team because it takes a different mindset"
(Project Management Institute,
2021)
.
5
Question Four: Based on your Project Management (PM) knowledge from the course and
the case study, what additional PM methodologies or functions could be employed by a
manufacturing organization to adapt or prepare for an emergency like the COVID-19
pandemic?
1.
Regulatory Frameworks-
Governments that want to implement flexible supply chain
management must modify their existing regulatory frameworks. Patient safety and ethics
during emergency organizations can implement social distancing guidelines and
sanitization protocols. Intellectual property protection laws should be flexible because
invention in an emergency could be a very tough task (Nadiya,S., 2024,Jan 09)
.
2.
Documentation and Data- Training, documentation, and data management are all
essential strategies a manufacturing organization can implement. GDP (Good
Documentation Practices) at the workplace guarantees accuracy and consistency in data
and processes, and GDP can trace data at any time and from any location. GMP helps
organizations with consistency in the Quality of products and makes it easy to get
approval from regulatory bodies in emergencies (Nadiya, S., 2024, Jan 16)
.
3.
Timelines-
Time is of the essence when it comes to Regulatory document submission
during emergencies, along with the submission of Regulatory packages, monitoring and
tracking the progress of their submission, and providing on-time query solutions of the
Regulatory Agency is one of the crucial tasks (Nadiya, S., 2024, Jan 16)
.
4.
Communication and Coordination-
Obtaining regulatory agency approval for any
product necessitates effective written communication via telephone. Moreover, company
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authorities must participate in conferences and meetings to be aware of this competitive
world (Nadiya, S., 2024, Jan 16)
.
References
1)
Project Management Institute. (2021). AstraZeneca Fighting a Global Pandemic. Project
Management Institue
.
2)
Marione Eisele, N. J. (2021). Strategies in Primary Care to Face the SARS-CoV-2 /
COVID-19 Pandemic: An Online Survey. National Library Of Medicine
.
3)
Nadiya,S. (2024,Jan 09). Week-1(Powerpoint Slides).
eConestoga.
4)
Nadiya,S. (2024,Jan 16). week-2(Powerpoint slides).
eConestoga.
5)
Project Management Institute. (2021). AstraZeneca Fighting Global Pandemic. Project
Management Institute
.
6)
Yen-Chin Liu, R.-L. K.-R. (2020). COVID-19: The first documented coronavirus.
Biomedical Journal
, 328-333.
7)
Youssef Miyah, M. B. (2022). COVID-19 Impact on Public Health, Environment,
Human Psychology, Global Socioeconomy, and Education. National Library of
Medicine
.
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