PHRM06009 2016 Introduction to Pharmaceutical Science

General Details

Full Title
Introduction to Pharmaceutical Science
Transcript Title
Introduction to Pharmaceutical
Code
PHRM06009
Attendance
N/A %
Subject Area
PHRM - Pharmaceutical Science
Department
LIFE - Life Sciences
Level
06 - NFQ Level 6
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2016 - Full Academic Year 2016-17
End Term
2019 - Full Academic Year 2019-20
Author(s)
Declan Shelly, Tom Patton
Programme Membership
SG_SPHAR_C06 201300 Higher Certificate in Science in Pharmaceutical Science
Description

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.

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Recognise the general requirements of the pharmaceutical Industry in Ireland/Globally .

2.

Identify the main types/sources and classes of pharmaceutical products.

3.

Explain the manufacturing cycle in the production of pharmaceuticals.  

4.

Discuss the importance of quality, safety, efficacy and traceability for pharmaceuticals

5.

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 Assessments

Repeat Continuous Assessment.

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

Indicative Syllabus

Introduction to Pharmaceuticals

Terminology, general requirements of pharmaceuticals the manufacturing processes and pharmaceutical companies in Ireland and Globally.

 Pharmaceutical Products

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

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Question and Answer sessions.Class / Group Discussions. Formative UNKNOWN - % OnGoing 1,2,3,4,5
2 Assignment Work.
Written Presentations. Oral Presentations.
Continuous Assessment Assignment 100 % OnGoing 1,2,3,4,5
             

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Group Learning Flat Classroom Group Learning 2 Weekly 2.00
Independent Learning UNKNOWN Self Study 5 Weekly 5.00
Total Full Time Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
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.

Module Resources

Non ISBN Literary Resources

N/A

Journal Resources

Journal of Pharmaceutical Sciences. ISSN: 0022-3549

URL Resources

EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines.

https://www.fda.gov/

https://www.ich.org/home.html

https://www.hpra.ie/

https://www.ema.europa.eu/en

https://www.thepsi.ie/gns/home.asp

https://jpharmsci.org/

Other Resources

None

Additional Information

None