Life Sciences & Medicine
Continuing Professional Development (CPD)
Available course dates:
To be confirmed
*Please note that applicants to this short course should go via King's Apply (click red 'Apply' button on the right of this page) and select the following programme*:
Pharmaceutical Medicine Non-Award (Part-time)
Module code 7BBP0011
The themes of safety and ethics come into all the fields of medicine development. This module covers both themes in depth. This module is particularly useful for individuals who have or expect to have the responsibility for making key decisions that involve issues of safety and ethics within clinical development.
The module will discuss the principles of ethics, and review typical issues of ethics that arise in biomedical research and pharmaceutical medicine; discuss the issues of protecting research subjects and minimising risk; discuss ethical aspects in research questions and study designs from first-in- human to post-marketing and epidemiological studies; explain issues surrounding conflict of interest; explain ethical issues of reimbursement; compensation and inducement; allow reflection upon the informed consent process; privacy; and confidentiality and data protection.
The module also discusses the principles of pharmacovigilance. The concept of risk is also covered, for example, in terms of how risks are involved in progressing a medicine through drug development and risk management.
What does this course cover?
- To provide advanced training in the holistic principles associated with drug safety and ethics.
- To give students an in-depth understanding of the social, political and economic factors that influence the safety and ethics of drug development.
- To instil an in-depth understanding of the roles that drug safety and ethics play in the protection of clinical research participants.
- Empower students to critically analyse the relevant pharmacoepidemiology, clinical and non- clinical studies that provide evidence of drug safety.
- Empower students to contextualise the role of ethics in each drug development program.
- To enable students to develop a clear, articulate and unbiased approach to the interpretation and assessment of data that has an ethical or a drug safety dimension.
What will I achieve?
By the end of this module students will be able to:
- Critically evaluate non-clinical safety data and assess how this might inform clinical decisions.
- Analyse and report adverse event data from clinical trials.
- Critically evaluate spontaneous adverse event data and determine whether there is enough information to suggest that a signal has been generated.
- Deploy pharmacoepidemiology skills, including the statistical methodologies to strategically evaluate a drug product
- To create a risk management plan.
- Critically evaluate a published paper describing a drug safety study.
- Critically review a published paper of a clinical trial and comment on whether or not it complied with ethical principles.
- Interpret clinical trial designs that address specific ethical issues e.g. in special patient populations.
- Create a consent process that satisfies the required standards of ethics to ensure that clinical research participants are protected.
- Create multi-national clinical development programmes that protect study participants despite the many differences in the standards of ethics practised worldwide.
Who is this for?
Minimum entry requirements are either a medical degree (such as an MBBS) or a 2:1 first degree in pharmacy, pharmacology, biology, biochemistry, chemistry or related subject.
This module is particularly useful for individuals who have or expect to have the responsibility for making key decisions that involve issues of safety and ethics within clinical development.