| CODE | PHR5010 | ||||||||||||
| TITLE | Pharmaceutical Regulatory Sciences | ||||||||||||
| UM LEVEL | 05 - Postgraduate Modular Diploma or Degree Course | ||||||||||||
| MQF LEVEL | 7 | ||||||||||||
| ECTS CREDITS | 5 | ||||||||||||
| DEPARTMENT | Pharmacy | ||||||||||||
| DESCRIPTION | The study-unit is designed to prepare graduates with backgrounds from pharmaceutical technology, science and pharmacy for positions in the pharmaceutical industry and in regulatory affairs. The study-unit presents the pharmaceutical regulatory framework from an international perspective addressing the development, manufacture, distribution and use of medicinal products. The impact of regulations and the challenges experienced are discussed. Study-unit Aims: - To present the international pharmaceutical regulatory framework; - To assist the students in appreciating processes and procedures for the development, manufacture and marketing of medicinal products; - To distinguish processes relevant for different medicinal products and medical devices; - To reflect on the impact of development of medicinal products on product information for final label, packaging, advertising and product leaflets. Learning Outcomes: 1. Knowledge & Understanding: By the end of the study-unit the student will be able to: - Compare regulatory processes; - Appreciate responsibilities by competent authorities and the pharmaceutical industry; - Demonstrate an understanding of ethics in pharmaceutical regulatory affairs. 2. Skills: By the end of the study-unit the student will be able to: - Develop and assess documentation for medicinal products including innovative products; - Monitor and evaluate operations and processes related to clinical trials; - Critically appraise product related information used in the labelling, packaging and marketing of the product; - Estimate and manage risk in healthcare from a context of pharmaceutical regulation. Main Text/s and any supplementary readings: - Crommelin DJA, Sindelar RD, Meibohm B (eds). Pharmaceutical Biotechnology: Fundamentals and Applications. Springer. 4th edition 2013. - Huml RA. Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional. Springer. 2012. - Mussen F, Salek S, Walker S. Benefit-Risk Appraisal of medicines: A systematic approach to decision-making. Wiley-Blackwell. 2009. - Regulatory Affairs Professional Society. Fundamentals of International Regulatory Affairs, Second Edition. 2013. - Tobin JJ, Walsh G. Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices. Wiley Blackwell. July 2008. ISBN: 978-3-527-31877-3. - Wood LF, Foote M (eds). Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics. Birkh盲user Basel. 2009. |
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| STUDY-UNIT TYPE | Lecture and Tutorial | ||||||||||||
| METHOD OF ASSESSMENT |
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| LECTURER/S | Mark Cilia Charmaine Gauci Maresca Attard Pizzuto Anthony Serracino Inglott |
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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. |
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