| CODE | PHR5011 | ||||||||||||
| TITLE | Pharmacovigilance | ||||||||||||
| UM LEVEL | 05 - Postgraduate Modular Diploma or Degree Course | ||||||||||||
| MQF LEVEL | 7 | ||||||||||||
| ECTS CREDITS | 5 | ||||||||||||
| DEPARTMENT | Pharmacy | ||||||||||||
| DESCRIPTION | The study-unit focuses on providing practical and theoretical aspects of pharmacovigilance. The concepts, effective processes and drug safety practices within a global pharmaceutical regulatory framework are presented. Study-unit Aims: - To present pre- and post-marketing drug safety and pharmacovigilance regulatory requirements; - To develop risk management strategies; - To identify methods used in signal detection and analysis; - To appraise regulatory requirements for drug safety and risk management in various global settings. Learning Outcomes: 1. Knowledge & Understanding: By the end of the study-unit the student will be able to: - Describe principles of regulatory framework for clinical drug safety; - Identify harmonisation initiatives for global approach; - Describe good clinical trials and pharmacovigilance practice. 2. Skills: By the end of the study-unit the student will be able to: - Develop standard operating procedures for pharmacovigilance activities; - Plan pharmacovigilance activities; - Develop risk-benefit assessment procedures; - Assess seriousness, expectedness and causality of adverse drug events; - Interpret and manage safety signals; - Carry out the duties required of a QPPV. Main Text/s and any supplementary readings: - Andrews EB, Moore N (ed). Mann's Pharmacovigilance. Wiley-Blackwell, 3rd ed. 2014. - Aronson JK. Meyler's Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and Interactions. Elsevier. 2006. - Lee A. Adverse Drug Reactions. 2nd ed. Pharmaceutical Press. 2nd ed. 2005. - Talbot J, Aronson JK, (ed). Stephens’ detection and evaluation of adverse drug reactions: principles and practice. 6th ed. Wiley-Blackwell; 2012. |
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| STUDY-UNIT TYPE | Lecture and Tutorial | ||||||||||||
| METHOD OF ASSESSMENT |
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| LECTURER/S | John Joseph Borg Benjamin Micallef Anthony Serracino Inglott Brockdorff Bettina Von |
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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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