This is a Biology/Management assignment (More leaning towards Management) All of the instructions and supporting materials are provided. You must submit: 1. Completed Risk Management Planning Worksheet for one of the identified risks, using the provided template. 2. Completed FMEA table for all six risks, please use the template. 3. A summary stating if you believe the risks indicate that the product should or should not be marketed and the justification for your choice(include any assumptions you have made.) The paper will be submitted to TURNITIN for similarity check, please make sure the paper is original and free of plagiarism. Please finish this paper well before the deadline(at least 4 hours earlier than the deadline), and finish with a platinum Quality.
BioBusiness 2018
Risk Management Tools: Clinical Trials, Ethics, Quality
and Safety
You are a pharmaceutical company that has developed a new drug delivered via
subcutaneous injection to treat rheumatoid arthritis.
Section 1: Clinical Trial – Phase III
You have completed Phase I and II successfully and now wish to do Phase III.
A: Prepare information about your proposed Phase III trial covering the following topics:
1. Purpose of the Phase III Trial
2. Ethical Considerations
a. Will this be a placebo controlled trial? State your reasons and risk
assessment
b. Are there any group(s) of the general population that will be excluded from
this trial? State your reasons and risk assessment
3. What will be your acceptance criteria, i.e. how will you measure if your arthritis
treatment is successful or unsuccessful?
B: You will engage a Clinical Research Organisation to carry out the trial – state their key
contractual obligations to you, and your key contractual obligations to them.
Section 2: Production – Quality Management System
Select four of the (4) elements of the Quality Management System (QMS) that will be used
by your company in the manufacture of this medication once it is approved. The list of
elements is below. For each element selected, explain why it is important, particularly
considering that this is a new product in the market.
The QMS Elements are:
• Deviation Management
• Corrective and Preventative Action
• Change Control
• Product Quality Reviews
• Complaints and Recalls
Section 3: Marketing – Risk Assessment
The Phase III clinical trial is completed. Suppression of the immune system which may lead
to severe or fatal infections in patients has been noted as a rare side effect of this
medication.
Identify and assess at least 2 risks to each of the patient, the company and the regulator
(TGA) in approving and marketing this product (Total 6 risks minimum). The risks should all
relate to the possibility that, after approval by TGA and commencement of commercial
manufacture, an unacceptable rate of infection due to immune system suppression occurs
amongst the patient population. Develop possible mitigation strategies for these risks.
You must submit:
1. A completed Risk Management Planning Worksheet for one (1) of the identified
risks, using the provided template
2. A completed FMEA table for all six (6) risks, using the provided template
3. A summary stating if you believe the risks indicate that the product should or should
not be marketed and the justification for your choice (include any assumptions you
have made)
Report requirements
Your assessment must be accompanied by a completed UTS individual assignment
declaration form.
Address all areas of the assessment under suitable headings and divided into the three
specified sections.
Use the provided templates for the Risk Management Planning Worksheet and the FMEA.
Submit your work through Turnitin to obtain a similarity assessment. The files (your report
and the two risk management files) can be zipped together and submitted as one file to
Turnitin. In addition, a hard copy of your assessment is to be submitted to the office of Dr
Rachel Shepherd by midnight on Friday 25th May. Slide your report under the door if the
office is unattended.
Word limit: 2000- 3000 words.
