| CODE | PHR3610 | ||||||||
| TITLE | Pharmaceutical Regulatory Sciences 3 | ||||||||
| UM LEVEL | 03 - Years 2, 3, 4 in Modular Undergraduate Course | ||||||||
| MQF LEVEL | 6 | ||||||||
| ECTS CREDITS | 4 | ||||||||
| DEPARTMENT | Pharmacy | ||||||||
| DESCRIPTION | This study-unit is concerned with the final steps in the drug development process. The importance of post marketing surveillance and marketing of of pharmaceutical products will be highlighted. Post marketing surveillance addressing: - Safety issues & pharmacovigilance - Quality issues and defective medicines reporting Post-marketing studies assessing: - Drug efficacy in prolonged use - Comparative data between new drug and standard drugs - New indications Marketing of medicines: - Presentation of medicinal products - Patents and data exclusivity - Advertising - The legal supply chain Study-unit Aims - To establish the importance of post marketing surveillance. - To explore the methods of marketing new medicines. - To identify key aspects of the legal supply chain. Learning Outcomes 1. Knowledge & Understanding: By the end of the study-unit the student will be able to: - List requirements in post-marketing surveillance. - Outline strategies for marketing pharmaceutical products. 2. Skills: By the end of the study-unit the student will be able to: - Assess product characteristics. - Apply communication skills to disseminate information on pharmaceutical products as appropriate. Main Text/s and any supplementary readings - Rang HP, editor. Drug discovery and development: Technology in transition. Philadelphia: Elsevier Limited; 2006. |
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| RULES/CONDITIONS | Before TAKING THIS UNIT YOU MUST TAKE PHR2610 | ||||||||
| STUDY-UNIT TYPE | Lecture | ||||||||
| METHOD OF ASSESSMENT |
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| LECTURER/S | Anthony Serracino Inglott Lilian Wismayer Maurice Zarb Adami |
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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 Units not attracting a sufficient number of registrations may be withdrawn without notice.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 2023/4. It may be subject to change in subsequent years. |
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