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10 pages/≈2750 words
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Health, Medicine, Nursing
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Plan Supporting the Development of Covid-19 Vaccine for Shipment Abroad (Essay Sample)


Please, include the diagrams and the tables in the word count.
As head of the Regulatory Affairs team in a large BioPharma manufacturing company you have been tasked with laying out a plan for supporting development of a Covid Vaccine for shipment to countries USA, Canada, Australia, Japan and Brazil.
The parent company is headquartered in mainland USA and has manufacturing facilities in Ireland.
Please provide detail on how you would approach the Regulatory Strategy in this plan under the headings listed below.
Title: Provide a suitable and specific title to represent the content of the report.
Introduction: Short Introduction with references. 5%
Aims: Specify the aims that you will be aiming to achieve.
Discussion: Main Content (this section can have headings and sub-headings as well). 20%
Sub-headings: Based on the different stages of the key areas impacted in your BioPharma company.
Flow diagram: Neatly presented (self-made and labelled).
Tables: (self-made linked with the flow diagram and labelled).
Explanations: For each stage in detail.
Conclusion and recommendation: Report. 10%
References: (Harvard Style) 5%


Plan Supporting the Development of Covid-19 Vaccine for Shipment Abroad
Student's Name
Institutional Affiliation
Course Name and Number
Professor's Name
According to the World Trade Organization (WTO), the international trade of human vaccines has expanded by a factor of five since 2005 (Evenett et al., 2021). Complete supply chain and logistics systems are the foundation of effective immunisation programs. Operational vaccine development, manufacture, handling, storage, and stock control; stringent temperature regulation in the supply chain; and proper operation of logistics supervision data structures are all responsibilities of the supply chain (Excler et al., 2021). The purpose is to guarantee that high-quality vaccinations are always available from production through distribution so that vaccination opportunities are never lost because of a lack of vaccines. This paper seeks to lay out a plan for supporting development of a Covid-19 Vaccine for shipment to countries like USA, Canada, Australia, Japan and Brazil
This paper aims to outline a strategy to facilitate the research, development, regulatory approval, and international distribution of a vaccine against COVID-19 in five countries: The United States of America, Canada, Australia, Japan, and Brazil. The goal of the plan is to ascertain and meet all necessary regulations. The purpose of this paper is to outline a strategy for meeting the regulatory requirements of each country. This includes learning about any clinical trial, production, labelling, or distribution specifications and the regulatory processes that must be followed to gain approval.
Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and other applicable requirements across jurisdictions 

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