MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details
Year of entry: 2020
Course unit details:
Product Development Management (PIAT 16)
|Unit level||FHEQ level 7 – master's degree or fourth year of an integrated master's degree|
|Teaching period(s)||Variable teaching patterns|
|Available as a free choice unit?||No|
This unit covers compound selection, market research, intellectual property, regulatory affairs, chemical, analytical and formulation development, pharmacology, toxicology, clinical trials, packaging, QA, product and marketing development, product launch, information technology, and management of project and portfolio of projects.
The unit aims to convey to students how all of the different functional aspects of drug development combine and are integrated within a (global) product team. The team manager has the responsibility to manage, timeline, cost and risk. Many students are from one specialist background and it is valuable to understand the overall process, as few people have the chance to take a drug from bench to bedside.
Teaching and learning methods
Aside from the course materials, there are extensive references to websites that contain more details and are, in many cases, constantly updated. There are certain key websites students must be familiar with. In the summer schools, students will have access to a drug development game, Test Tubes to Tablets.
The course is broad and many topics can be explored in depth by using the appropriate search terms and seeking presentations on the subjects, but students are also encouraged to discuss key points of interest with their tutor.
Knowledge and understanding
There are many detailed terminologies relating to drug discovery and development, as well as the principles in developing either a novel or best in class new drug.
- To understand the regulatory framework that envelops development and manufacturing, and sales of drugs.
- Concepts regarding uncertainty, and weighing of evidence and understanding key factors in the variability of drug handling between patients.
Develop and understand the practical skills for participation in a product development team - problem solving, risk assessment and decision trees - as well as the personal skills required of team members.
Transferable skills and personal qualities
The skills of planning, risk management and project management, clear writing skills and attention to detail can be applied to other related and unrelated topics.
|Written assignment (inc essay)||100%|
Provisional marks and feedback for coursework returned within 15 working days.
Exam marks and final marks returned after ratification at exam board.
|Independent study hours|
|Matthew Shaw||Unit coordinator|