| CODE | PHR2610 | ||||||||
| TITLE | Pharmaceutical Regulatory Sciences 2 | ||||||||
| UM LEVEL | 02 - Years 2, 3 in Modular Undergraduate Course | ||||||||
| MQF LEVEL | 5 | ||||||||
| ECTS CREDITS | 4 | ||||||||
| DEPARTMENT | Pharmacy | ||||||||
| DESCRIPTION | - Clinical Trials - Definition of clinical trials - Ethical considerations - Phase I, Phase II and Phase III clinical trials - Regulatory requirements for clinical trials - Role of regulatory authorities - Access to medicine - Ethics in equity and use of medicines - Registration of medicinal products. Study-unit Aims: - To establish the concept of Good Clinical Practice; - To describe processes involved in clinical trials; - To reflect on opportunities and challenges in registration and access to medicines. Learning Outcomes: 1. Knowledge & Understanding By the end of the study-unit the student will be able to: - Explain the concept of clinical trials in drug development; - Recognise different stages and requirements in clinical trials; - Describe registration process of medicinal products. 2. Skills By the end of the study-unit the student will be able to apply concepts of regulatory affairs in the running and participation in clinical trials and in considering access to innovative medicinal products. Main Text/s and any supplementary readings: - Allen LV, Popovich NG, Ansel H. Ansel's pharmaceutical dosage forms and drug delivery systems. Baltimore: Lippincott Williams & Wilkins; 2005. - British Pharmacopoeia Commission Secretariat of the Medicines and Healthcare products Regulatory Agency. British Pharmacopoeia. London: The Stationery Office; 2011. ISBN 9780113228492. - Rick NG. Drugs: From discovery to approval. New Jersey: John Wiley & Sons; 2009. |
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| RULES/CONDITIONS | Before TAKING THIS UNIT YOU MUST TAKE PHR1610 | ||||||||
| STUDY-UNIT TYPE | Lecture | ||||||||
| METHOD OF ASSESSMENT |
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| LECTURER/S | Jessica Zarb Matthew Camilleri Anthony Serracino Inglott Lilian Wismayer |
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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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