Abstract We manage risk so frequently (and unconsciously) in our daily lives that we tend to underestimate its importance. In 2005, the ICH guideline Q9 officially introduced risk management into the pharmaceutical industry. Since then, it has been extensively used and, on occasion, misapplied. In practice, risk assessment tools are frequently viewed as an end in themselves, while important things like brainstorming and getting to know the problem are undervalued. A pharmaceutical project is an excellent example of this: risk management is critical, but because there are so many unknown variables, it must be done in such a way that what matters is understanding the problems we face. A pharmaceutical project involves:
- At least two actors.
- A pharmaceutical company and an engineering firm with diverse backgrounds.
- Frequently resulting in divergent approaches.
This could explain why risk management should be used more in pharmaceutical projects. As a result, this chapter examines a pharmaceutical project from a risk management standpoint.
You will be pre-assigned as a team to one of the following Units: Unit Four: Autonomic Nervous System Drugs; Unit Five: Central and Peripheral Nervous System Drugs.
This is a 4 week activity. You will stay in your team for each of the weeks that follow.
Prepare a 15 minute Summary Presentation for class to include the following:
- Summary of the Unit/Classification
- Minimum of three types of drugs or supplements
- Typical routes of administration
- Common side effects and adverse effects
- Special considerations
- Common Nursing interventions
Teams must distill the material to only key points. The presentation may be a Power Point, lecture and handouts, poster or any way the team feels they will best present the information. Use your textbook and Davis’s Drug Guide as your resources.
Teams collect points over the four weeks for their presentation. They are graded on their accuracy and thoroughness of their presentation as well as how well they worked as a team. At the end of the four modules, each team will be awarded an Olympic medal for the number of points earned.