| CODE | PHR5013 | ||||||||||||
| TITLE | Specialisation in Pharmaceutical Regulatory Sciences | ||||||||||||
| UM LEVEL | 05 - Postgraduate Modular Diploma or Degree Course | ||||||||||||
| MQF LEVEL | 7 | ||||||||||||
| ECTS CREDITS | 20 | ||||||||||||
| DEPARTMENT | Pharmacy | ||||||||||||
| DESCRIPTION | The specialisation in pharmaceutical regulatory sciences is designed to give students competencies in implementation and development of pharmaceutical regulatory framework around the manufacture, distribution, dispensing, and use of pharmaceutical products.Students will be trained for a career in different aspects of drug regulation including assessment of innovative therapies, pharmacovigilance, clinical trials and audits upon the successful completion of this unit. Study-unit Aims: - To present science-based principles of drug, biological products and medical devices development, evaluation, and regulation; - To appraise the application of pharmaceutical regulatory principles within a global perspective. Learning Outcomes: 1. Knowledge & Understanding By the end of the study-unit the student will be able to: - devise and implement global strategies for pharmaceutical regulation related to development and evaluation of medicinal products and pharmaceutical processes; - apply critical methods of risk assessment in pharmaceutical processes; - evaluate economic factors that influence use and access to medicinal products; - establish and monitor policies related to pharmaceutical regulation and access to medicinal products. 2. Skills By the end of the study-unit the student will be able to: - interpret agencies' regulations and guide regulatory strategy and operations; - appreciate the role of regulatory authorities, regulations and guidelines in product development; - comprehend issues related to clinical research and regulatory affairs; - apply quality risk management from a context of pharmaceutical regulation. Main Text/s and any supplementary readings: - Attard Pizzuto M, Serracino-Inglott A, Azzopardi LM. Innovative Tools to Investigate Risk in Pharmaceutical Processes. Germany: LAP LAMBERT Academic Publishing. 2016. - 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. - Jones JK, Kingery E. History of Pharmacovigilance. In: Andrews EB and Moore N, editors. Mann’s Pharmacovigilance 3rd ed. United Kingdom: John Wiley & Sons, Ltd; 2014.p.11-24. - 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, Third Edition. 2017. - 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. Birkhäuser Basel. 2009. |
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| STUDY-UNIT TYPE | Lecture, Seminar and Tutorial | ||||||||||||
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| LECTURER/S | Annalise Attard Lilian M. Azzopardi John Joseph Borg Mark Cilia Charmaine Gauci Lara Marie Giudice Louise Grech Benjamin Micallef 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 2024/5. It may be subject to change in subsequent years. |
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