PHRM06009 2019 Introduction to Pharmaceutical Science
This module introduces students to the fundamental aspects of the pharmaceutical industry sector, both nationally and internationally. The pharmaceutical industry is one of the largest and most exciting sectors to be working in today. It is a rapidly changing environment where many advances have taken place over the past 25 years. Furthermore, it will continue to develop and evolve at an ever-increasing pace over the next decade. New drugs, new technologies and exciting new discoveries have driven this evolution.
On completion of this module the learner will/should be able to;
Recognise the general requirements of the pharmaceutical Industry in Ireland/Globally .
Identify the main types/sources and classes of pharmaceutical products.
Explain the manufacturing cycle in the production of pharmaceuticals.
Discuss the importance of quality, safety, efficacy and traceability for pharmaceuticals
Describe the role of the regulatory authorities in the Pharmaceutical industry.
Teaching and Learning Strategies
This module will be delivered full time. This will include lectures, augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as a potential means of assessment (e.g. quizzes, uploading assignments and journals).
Module Assessment Strategies
This module is 100% Continuous Assessment.
The continuous assessment and course work will involve several assignments where students will be required to (i) demonstrate an understanding of core module concepts, and (ii) presentations on topics which demonstrates the student's ability to critically evaluate an aspect of the subject area.
formative assessment - Self-assessment tests and other forms of formative assessment are provided to students to check their own progress towards achieving the learning outcomes of the module and to motivate learning.
Repeat Continuous Assessment.
Introduction to Pharmaceuticals
Terminology, general requirements of pharmaceuticals the manufacturing processes and pharmaceutical companies in Ireland and Globally.
Sources of drug substance and products, Patented and generics, Classification of pharmaceuticals, topical, oral dose, parenterals, aerosol, OTC, prescription, sustained release products, biopharmaceuticals etc.
Overview of Pharmaceutical Manufacture
The manufacturing cycle in the production of pharmaceuticals. Processes of formulating, product development and phases of clinical development, Solvent recovery and waste minimizations.
GMP in Pharmaceutical Manufacturing
Raw Material Control and Production Procedures: batch control and identification, processing, package and labelling. Requirements for the validation of processes and equipment and the adoption of processes controls. Safety issues in pharmaceutical manufacturing including falsified medicines.
The Standard Operating Procedures
The importance of quality and product safety by standardising work practices and controlling procedures in a GMP environment.
Quality,Safety and Efficacy in Pharmaceutical Products
Role of regulatory authorities , Health Products Regulatory Authority (HPRA), European Medicines Agency (EMA), Food and Drug Administration (FDA). International Conference on Harmonisation (ICH).
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Question and Answer sessions.Class / Group Discussions.||Formative||UNKNOWN||- %||OnGoing||1,2,3,4,5|
Written Presentations. Oral Presentations.
|Continuous Assessment||Assignment||100 %||OnGoing||1,2,3,4,5|
Full Time Mode Workload
|Group Learning||Flat Classroom||Group Learning||2||Weekly||2.00|
|Independent Learning||UNKNOWN||Self Study||5||Weekly||5.00|
Required & Recommended Book List
2011 An Introduction to Pharmaceutical Sciences Biohealthcare Publishing (Oxford) Limited
ISBN 1907568522 ISBN-13 9781907568527
"This book explains how a particular drug was discovered and then converted from lab-scale to manufacturing scale, to the market. It explains the motivation for drug discovery, the reaction chemistry involved, experimental difficulties, various dosage forms and the reasoning behind them, mechanism of action, quality assurance and role of regulatory agencies."--Back cover.
Journal of Pharmaceutical Sciences. ISSN: 0022-3549
EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines.