Monash University Handbook 2011 Undergraduate - Unit

Refer to the specific census and withdrawal dates for the semester(s) in which this unit is offered.

Level	Undergraduate
Faculty	Faculty of Pharmacy and Pharmaceutical Sciences
Offered	Parkville Second semester 2011 (Day)
Coordinator(s)	Dr Laurence Orlando

Synopsis

There are three main aspects associated with Product Development in the Pharmaceutical Industry, Quality, Safety and Efficacy. This unit will focus on Quality. The lecture material and activities are designed to give students the necessary background and exposure to the various aspects of Product Development that impact on the Quality of Therapeutic Products and regulatory controls that are used to ensure quality is maintained.

Students will develop an understanding of:

• the development processes for therapeutic goods
• the labelling requirements specifically for therapeutic goods
• the many facets of GMP, GLP and quality assurance,
• introduction to intellectual property,
• product approval processes in Australia, the USA and Rest of World
• introduction to clinical trials
• issues and processes in the marketing of pharmaceutical products,

The students will gain industry relevant expertise in:

• assembling product specification documentation,
• writing controlled documents such as standard operating procedures
• Designing a manufacturing area with due regard to regulatory requirements

The unit also includes an Industry Week with the primary aim of the students gaining an appreciation of how the product development process is conducted in a real world situation. Debrief sessions provide a non-intimidating forum for students to present a five minute summary of their experience in Industry Week and how aspects of the course work related to their experience, providing the students with valuable public speaking/communication experience.

Objectives

At the end of this unit students will be able to:

1. Describe the various stages in Drug Product Development and product registration process
2. Source required information on drugs, dosage forms, drug products and test methods from pharmacopoeia to support product development activities
3. Prepare a specification document for a pharmaceutical product including a valid label
4. Discuss the issues associated with development and quality control under GLP conditions.
5. Describe what is meant by quality assurance and how it relates to manufacturing processes and product development
6. Describe what is involved in obtaining a GMP licence to manufacture therapeutic goods, and the recording and documentation required to maintain it.
7. Prepare a Standard Operating Procedure.
8. Describe the approval processes for therapeutic products
9. Provide a description of the different stages of clinical trials
10. Describe terminology and basic concepts around intellectual property
11. Discuss the issues involved in the marketing of pharmaceutical products.

Assessment

Final exam (3 hour): 60%; written assessments: 40%.

Chief examiner(s)

Dr Laurence Orlando

Contact hours

22 hours of lectures; 11 hours of tutorials; 2 hours of presentations; 30 hours practical classes (industry week)

Additional information on this unit is available from the faculty at:

http://www.monash.edu.au/muso/support/