evaluation of the role of pharmacovigilance in post marketing authorisation in terms of risk-benefit assessment

Order Description
* This will be my proposal for a PhD research.
* The research will be evaluating the current methods in assessing the risk benefit in drug development and particularly post marketing authorisation
* In the attachment I uploaded some references that I want you to follow please.
* please follow the following guidelines requested by the university:

A working title: Make this clear and descriptive
• Some background and rationale
o Explain the background and issues of your research
o What are your aims and objectives?
o What are the parameters? Explain why you have chosen them?
• Clear and defined research question (s).
o Your question needs to be answerable within a set timeframe
• A description of your theoretical framework and methodological approach.
o Why is this best suited to your topic?
o What are the theoretical and research issues related to your research question?
o What sources / data will you use?
o What are the activities necessary for the completion of your project?
o Will you need to collaborate with other researchers or organisations?
o Are there ethical considerations that need to be considered?
o How realistic is your project in practical terms?
• An brief analytic discussion of the scholarly research to date on your topic.
o What is the current state of your field?
o Acknowledge the main contributors in this field
o In what ways will your research create valuable and useful knowledge?