| CODE | CPH1903 | ||||||||
| TITLE | Drug Discovery, Development, Regulatory Aspects, Pharmacovigilance | ||||||||
| UM LEVEL | 01 - Year 1 in Modular Undergraduate Course | ||||||||
| MQF LEVEL | 5 | ||||||||
| ECTS CREDITS | 4 | ||||||||
| DEPARTMENT | Clinical Pharmacology and Therapeutics | ||||||||
| DESCRIPTION | Drugs go through various stages before reaching the market, from the discovery of a drug entity to development into a viable medicine. Before reaching the market it need to fulfill stringent regulatory requirements to ensure safety and efficacy. Ongoing safety is ensured through the study of the medicines once they are being used in a real practice settings as opposed to controlled clinical trial settings. This study unit will address all the above stages. This study-unit will provide students with the science and process involved in drug discovery, it will address pre-clinical research as well as clinical trials. It will incorporate regulatory processes necessary to satisfy regulators at a national and European levels. It will also incorporate the science of pharmacovigilance to ensure medication safety. Study-unit Aims: This study-unit aims to provide students with an in depth understanding of of the processes involved of getting a drug to the market from the point of a chemical entity being a drug candidate to its availability on the market and ongoing assurance of its safety for use by patients. It aims to enable students to appreciate the full spectrum of the process. Learning Outcomes: 1. Knowledge & Understanding By the end of the study-unit the student will be able to: - Identify and describe the stages comprised in the procedures used to identify potential drug leads; - Illustrate the regulatory process required to place a medicine on the market, and the function of major regulatory agencies; - Discuss what constitutes the science of pharmacovigilance and its contribution to patient drug safety. 2. Skills: By the end of the study-unit the student will be able to: - Recognize steps involved in drug discovery; - Identify he critical parameters of the various stages within the drug development process; - Prepare documentation required to obtain market authorization of a medicine; - Define pharmacovigilance and describe the processes required; - Prepare documentation relevant to the pharmacovigilance process. Main Text/s and any supplementary readings: Main Text: - Stromgaard K, Krogsgaard-Larsen P, Madsen U. Textbook of drug design and discovery. 5th Ed. 2016. CRC Press, Taylor and Francis. Supplementary reading: - British Pharmacopoeia. Commission Secretariat of the Medicines and Healthcare products Regulatory Agency. British Pharmacopoeia 2012. London: The Stationery Office. - Cad SC (ed). Pharmaceutical Manufacturing Handbook: Production and Processes. New Jersey: Wiley-Interscience. 2008. Additional Resource: - The European Medicines Agency. Human medicines regulation https://www.ema.europa.eu/en/human-medicines-regulatory-information [Open access resource]. |
||||||||
| STUDY-UNIT TYPE | Lecture and Independent Study | ||||||||
| METHOD OF ASSESSMENT |
|
||||||||
| LECTURER/S | Corinne Maria Bowman Josef Cachia Pisani Rachel Cilia Maria A. Cordina (Co-ord.) Anthony Fenech Janet Mifsud Charles Scerri Janet Sultana Mark Zammit |
||||||||
|
The University makes every effort to ensure that the published Courses Plans, Programmes of Study and Study-Unit information are complete and up-to-date at the time of publication. The University reserves the right to make changes in case errors are detected after publication.
The availability of optional units may be subject to timetabling constraints. Units not attracting a sufficient number of registrations may be withdrawn without notice. It should be noted that all the information in the description above applies to study-units available during the academic year 2025/6. It may be subject to change in subsequent years. |
|||||||||