Kriyesh Patel - Case Study #1
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Assignment #1
Kriyeshkumar Pravinbhai Patel
Regulatory Affairs, Conestoga collage
QUAL8420: Preparing Quality Regulation Submissions
Dr. Hamza Taufique
02-02-2024
Assignment #1
Question One: Briefly describe the Covid-19 global pandemic.
Chinese authorities reported to the WHO on December 31, 2019, regarding an unknown virus.
Wuhan Municipal Health observed the cases between December 12 and December 29. The virus
was first classified by the World Health Organization as 2019-nCoV, but Chinese officials
verified on December 7, 2019, that they had recognized it as a novel coronavirus. In January
2019, about 150 cases were observed in China, Japan, South Korea, and Thailand, along with a
couple of deaths. As a result of these, many countries denied entry to travelers who visited China
in the last 14 days and introduced a quarantine plan for those who traveled through China. Many
of the countries implemented a complete lockdown for the month to stop the spread of COVID-
19; despite this, COVID-19 spread across most of the continent and affected various sectors such
as education, public health, travel, and tourism and Millions of people were dying during this
pandemic around the globe. For Example, on May 27, 2022, the US government reported that
COVID-19 killed almost a million people across the United Nations. Also, COVID-19 had a
negative impact on global collective gross domestic product (GDP), which fell by 3.4% in 2020.
(CNN Health, January 2, 2024)
The primary measures that were taken to prevent the infection were social distancing, personal
hygiene, wearing a mask, lockdown (staying at home), COVID testing, a vaccination campaign,
home quarantine, and public awareness.
Question Two: Explain the risks and complexity of the challenges faced by AstraZeneca to
address the vaccine problem related to Covid-19 pandemic.
Clinical trial:
The Phase 3 clinical study requires significant, parallel investments since it must
proceed quickly and obtain urgent regulatory agency approval for usage, particularly from the
US Food and Drug Administration. (Barbara S, 2019)
The complexity of the project was driven by
the necessity to move swiftly. AstraZeneca had to schedule clinical studies alongside an
expansion of production capacity because of the vaccination project's accelerated timeline.
AstraZeneca had to design clinical studies alongside an expansion of production capacity
because of the vaccination project's accelerated timeline. (Project Management Institute, 2022)
Manufacturing capacity: -
To meet production requirements, AstraZeneca set up manufacturing
sites around the globe. It has established more than a dozen regional supply chains to enable
quick access to as many countries as possible. Working with over 20 supply partners in over 15
countries and with the support of over 20 analytical testing centers, expediting vaccine
manufacture and supply is possible. (astrazeneca, December 2021)
Project management: -
When the project was set to begin, AstraZeneca's Global Project and
Portfolio Management department found three flaws right away.
1)
internal project managers with expertise developing vaccines.
2)
Methods of project management appropriate given the pace at which the vaccination
project needed to move.
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3)
a government contracting agency inside that might help with the project. (Project
Management Institute, 2022)
Question Three: Discuss the project management infrastructure developed by AstraZeneca
to overcome the challenges identified in Question 2 and the results obtained.
PMO establishment:
Due to a lack of time, the PMO management team focused on four key
roles to start working on in time.
1)
Integration of schedule and budget. 2)
Contract management
3)
Team process guidance.
4)
Risk management.
Experienced project manager:
Not only they hired people but also from the internal because
hiring people from outside would take more time than it did for this project, they were looking
both within and beyond the team for people with relevant professional experience. Drawing on
her knowledge of their pasts as well as remarks made by other staff members within the
company. They employed personnel with prior expertise in managing government contracts and
vaccine projects. Even within it, they were unable to locate a specialist with knowledge of both
government contracts and vaccine research. Despite the difficulties, they managed to acquire
knowledgeable individuals within a week with HR assistance. Internal government contracting organization: create the government contract management
position inside the PMO. "It was crucial to have an independent office that could allow the focus
to be on contract deliverables instead of managing the team and the project. (Project Management
Institute, 2022)
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 Covid-19 pandemic.
Documentation and data:
Identified and collected any relevant data and documentation, such
as clinical trial results, preclinical data, manufacturing data, and pharmacovigilance data, that is
needed for the submission and make sure that all data is accurate, and that good manufacturing
and documentation practices are followed and submitted data to government authorities for
approval.
Timelines:
A project timeline helps you manage the overall timeline of a project and helps you
bulk plan tasks so you can understand what needs to be done and when.
Communication and coordination:
Important information that must be shared with
stakeholders at various points during the project is outlined in a project management
communication plan. Additionally, it establishes who will receive the communication, how,
when, and how frequently those recipients should anticipate receiving it.
Risk management:
Adopted a variety of techniques, including historical data, brainstorming,
and other techniques, to identify and classify risk, whether it be internal or external. Then, they
did a risk assessment and response with strategies and monitored each task very closely to reduce
risk. (Nadiya s, 2024, jan 16)
.
References
Covid-19 pandemic timeline fast facts
. (2021, August 9). CNN; CNN Editorial Research. https://www.cnn.com/2021/08/09/health/covid-19-pandemic-timeline-fast-facts/
index.html
How to Create a Project Management Communication Plan
. (2018a, December 19). Lucid chart.
https://www.lucidchart.com/blog/project-management-communication-plan
Innovating Production and Manufacture to meet the Challenge of COVID-19
. (2021). Astrazeneca.com. https://www.astrazeneca.com/what-science-can-do/topics/technologies/innovating-
production-and-manufacture-to-meet-the-challenge-of-covid-19.html
Pushing boundaries to deliver COVID-19 vaccine across the Globe
. (2021). Astrazeneca.com. https://www.astrazeneca.com/what-science-can-do/topics/technologies/pushing-
boundaries-to-deliver-covid-19-vaccine-accross-the-globe.html
Summary of the risk management plan for COVID-19 Vaccine AstraZeneca (ChAdOx1-S/AZD1222)
. (n.d.). https://www.medsafe.govt.nz/COVID-19/AstraZeneca-
RMP.pdf
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