Advancing Precision Medicine through Agile Governance Paper

Potential topics for the paper may include description of a case history in healthcare that details FDA and international regulatory agency collaboration on a specific issue in regulatory affairs, or you may elect to choose a current and ongoing topic of interest.

For instance, you may choose to discuss a health care related topic including but not limited to the current COVID-19 pandemic or the more recent Ebola virus outbreak and discuss how the WHO collaborated with other global healthcare agencies on case management, prevention and control of the infection. The paper should also discuss in detail how international regulatory agencies such as the EMA, FDA etc. collaborated with each other as well as with WHO in the development of new diagnostic tests, vaccines or therapies to combat the disease/condition and help accelerate approvals for the same for quick patient access while ensuring they are safe and effective.

Please use the lecture materials, supporting reading materials, materials from the past weeks available on Canvas including your own researched references. Remember to provide references to the sources that you have used. In addition to the Canvas materials, you may also choose to refer to the websites/documents listed below as background information for the paper.

• https://www.who.int/aboutLinks to an external site.
• https://www.who.int/health-topics/
• https://www.who.int/emergencies/en/Links to an external site.
• https://www.fda.gov/medical-devices/medical-device…
• https://www.fda.gov/emergency-preparedness-and-res…
• https://www.ema.europa.eu/en/authorisation-proceduresLinks to an external site.
• https://www.sciencedirect.com/science/article/pii/…