1. Generate a data model (i.e. an ER diagram) for the following system. Note that if you find, in creating your data model, that information you need is not included in the description above then make an appropriately reasonable assumption (and document it as part of your answer).

Vaccine Approval process for the fictitious country: Nirvanaland

To submit an application under the provisional pathway, a sponsor (usually a pharmaceutical company) must first submit a provisional request e-form.

The Vaccine Approval Authority (VAA), who is responsible for approval of drugs, will assess the application against specific eligibility criteria, such as the nature of preliminary clinical data, evidence of a plan to submit clinical data, and the clinical need.

If the VAA grants the provisional request, the sponsor is then eligible to apply for provisional registration of the vaccine in the Nirvanaland Register of Therapeutic Goods (NRTG).

Importantly, granting the provisional request does not mean that the sponsor will submit an application, or that the VAA will approve the subsequent application.

Once the provisional request has been granted, the sponsor then needs to submit an application for registration in the NRTG.

To register a COVID-19 vaccine in Nirvanaland, a sponsor is required to submit a comprehensive dossier that includes specific information on clinical studies, non-clinical/toxicology studies, chemistry, manufacturing, risk management and other information.

The VAA may agree upfront to accept a limited number of rolling submissions of data during the evaluation phases, as well as reports from comparable overseas regulators.

The VAA will make an initial assessment whether to accept the submission for evaluation and will notify the sponsor.

Once an application is accepted, the VAA will commence a formal evaluation process that is carried out in multiple phases by technical experts.

This process involves obtaining further information and clarification from the sponsor, as well as being informed by the advice of the Advisory Committee on Vaccines, an independent committee of external experts.

Once the evaluation is complete, the VAA delegate will confirm whether to register the vaccine in the NRTG. The confirmation of a new vaccine is always made by the VAA on the basis that the benefits outweigh the risks.

The VAA delegate's confirmation of registration is based on a number of factors including:

• the safety, quality and effectiveness of the vaccine has been satisfactorily established for its intended use
• the sponsor's plan to submit comprehensive clinical data, stability data and other information before the registration ends.

Once approved by the VAA, the vaccine is included in the NRTG as a registered medicine and can be lawfully supplied in Nirvanaland by the sponsor.

Approved vaccines will appear in the searchable NRTG on the VAA website.

The registration is for an initial period of two years, with the option to apply for up to two extensions, up to a maximum of six years.

The VAA will continue to play an active role in the ongoing monitoring of any vaccines available in Nirvanaland and has robust procedures in place to investigate any potential new safety issues.

The VAA's vaccine safety monitoring system can rapidly detect, investigate and respond to any emerging safety issues identified for COVID-19 vaccines.

The post-market monitoring relies on reviewing and analysing adverse events reports, working with international regulators and reviewing medical literature, media and other potential sources of new safety information.