Description As mentioned with the first three assigned cases key student learning outcome (s) for the course include demonstrating an understanding of compliance standards required to formulate regulatory strategies to support effective life -cycle management . This particular case is timely , given the COVID -19 pandemic , as well as ongoing efforts to develop and safe and effective vaccines to prevent its continued spread . Study objectives for this case include developing an appreciation for : 1) The importance of product development to respond rapidly to the needs of a global health initiative (including outbreaks , epidemics and pandemics ) 2) The complexities of ensuring the engagement of stakeholders involved in vaccine development 3) The potential role of the public sector in facilitating product development, including identifying public health needs , implementing a clinical study and regulatory pathway to licensing , and strategic planning for distribution and use As with the previous case write -up assignments the questions for this Case Study write - up require you to explain critical aspects of the case from a situational perspective , as well as to develop replies to specific questions presented by the case . Case Study Write -Up Questions