Module Leaders: Z. KalÃ³, Hungary and D. Dubois, Belgium - under discussion Pharmacoeconomic principles, their application in medicine development and marketing will be discussed. The healthcare market place, the principles and practice of drug marketing will be described. Finally the roles of Health Technology Assessment, patient organisations and methods used for pricing and reimbursement decisions, drug budget management will reviewed.
At the end of this Module the student should be able to demonstrate an understanding of: Life-cycle activities (clinical, regulatory and marketing). Processes of production and review of product information to ensure adherence to ethical and legal principles pertaining to marketing activities (Good Promotional Practice). Role of patient organisations. Principles and practical application of health economics and patient-reported outcomes within the pharmaceutical industry. Principles of health technology assessment (HTA) and its role in the supply of medicines to the marketplace. Principles and practice of marketing within the pharmaceutical industry. Drug budget control; pricing mechanisms. Explain the multidisciplinary nature of pharmacoeconomics and ethical boundaries, and the need for integration of knowledge from a range of health science disciplines in the management of sustainable health service challenges in the 21st century. (ELM) Use in an appropriate manner the fundamental scientific theories underlying the application of health economic techniques to a range of healthcare interventions. (ELM) Recognise and be capable of utilising basic relationships and techniques of healthcare management to maximise benefits from a given resource. (ELM) Explain and present information associated with economic appraisal and assessment of new medicines carried out by NICE or similar agencies. (ELM) Explain the role of the agencies which police the economic viability of existing and new medical technologies. (ELM) Compare and contrast the different challenges of healthcare expenditure presented in different economies. (ELM) Outline the structure of the global drug development and regulatory framework with emphasis on risk management in the context of benefit/risk assessment and the role of pharmacoeconomics and quality-of-life, and be capable of explaining its evolution, strengths and weaknesses. (ELM) Explain methods utilised in clinical trials for examining cost-effectiveness of new pharmaceutical products.
Quality - GMP, GCP, GLP