The aim of this module is to introduce the student to both the theoretical and practical aspects of basic microbiological techniques required to safely handle, investigate and manipulate micro-organisms in laboratory setting. Students will be provided with the opportunity to acquire knowledge of the subject matter through a variety of lecturer led activities and self-directed study. Such activities will include traditional and interactive lectures, problem solving and revision tutorials and laboratory practical classes. Theoretical and practical problems will be employed to assist students in the development of their analytical and problem solving capabilities.

1. Understand that microorganisms comprise a diverse range of organisms that includes bacteria, fungi, protozoans, algae, viruses and sub-viral particles.
2. Understand microbial structural diversity and classification.
3. Be aware of microbial physiological diversity which is reflected in a range of microbial activities in nature, in their importance in biotechnology and in health and disease. Understand the theoretical and practical principles underpinning a diverse range of methodologies aimed at controlling microbial growth.
4. Be capable of manipulating and interpreting numerical data relating to microbiological analysis.
5. Understand the importance of, and work in compliance with, health and safety policies and good laboratory practice as it pertains to microbiology laboratories.
6. Demonstrate an awareness of key principles of Microbiology and be able to explain major microbiological concepts by demonstrating a capacity for critical scientific analysis of relevant issues.
7. Be able to design and execute experiments, systematically collect and analyze data, identify sources of error, and interpret the results and reach logical conclusions. They should also have a basic understanding of safety issues.
8. Operate basic laboratory instruments used in microbiology practical experimentation.
9. Apply the scientific method by stating a question; researching the topic; determining appropriate tests; performing tests; collecting, analyzing, and presenting data; and finally proposing new questions about the topic.
10. Be able to (1) differentiate between fact and opinion, (2) recognize and evaluate author bias and rhetoric, (3) develop inferential skills, (4) recognize logical fallacies and faulty reasoning, and (5) make decisions and judgments by drawing logical conclusions using sound quantitative and statistically-based reasoning.
11. Understand and appreciate the value of cooperating and working effectively with peers and be able to demonstrate a commitment to the process of developing such skills.

This module examines the structure and chemistry of aliphatic organic molecules, covering saturated and unsaturated hydrocarbons (both cyclic and alicyclic) and the various functional groups. Reactivity and reaction mechanisms for a selection of functional group inter-conversions will be studied as will some important organometallic compounds.

1. Expalin the concept of hybridisation in describing the structure of some hydrocarbon molecules
2. State the factors effecting stability and structure of cycloalkanes.
3. Identify the reactions involved in the interconversion the various functional groups.
4. Explain the reaction mechanisms involved in a selection of organic chemical reactions.
5. Evaluate the use of some organometallic reagents.
6. Perform a series of Organic Chemistry practicals

This module enables students to explain the functions, structures and properties of biomolecules including their roles in disease. Additionally, the development of laboratory-related skills is facilitated among students.

1. Describe the structure, function and characteristics of, carbohydrates, fats, nucleic acids and proteins (including those used to treat disease).
2. Demonstrate knowledge of nature, function and properties of enzymes (including enzyme inhibition and its pharmaceutical applications) and experimentally determine enzyme activity along with some key properties.
3. Review the fundamental characteristics of body defence systems including antibodies and experimentally determine the presence of antigen using immunoassay techniques.

4. Demonstrate proficiency in the performance of a variety of laboratory techniques.
5. Utilize scientific knowledge and technical procedure to analyse, evaluate and explain specific experimental outcomes through oral and written communication.

This module will give students a foundation in Environmental Health and Safety enabling them to apply these fundamentals to the area of pharmaceutical science.

1. Identify hazards in the workplace and apply appropriate control measures with special reference to the needs of the pharmaceutical sector.
2. Outline the parameters used for Environmental Health and Safety monitoring in Ireland
3. Examine the links between environmental andoccupational safety andhealthissues in the workplace.
4. Identify and analyseOccupational Safety and Healthand Environmental legislation with reference to its impact on the Pharmaceutical sector.
5. Communicate the need for effective management of Environmental, Health and Safety issuesin the workplace.

This module introduces students of physical sciences to the concepts of gas behaviour, thermodynamics, chemical equilibrium, electrolytes and acid-base behaviour.

1. Define various laws that are fundamental to physical chemistry.
2. Describe the behaviour of gases (ideal and non-ideal).
3. Explain the laws of thermodynamics and manipulate chemical equations to calculate physical parameters.
4. Describe the behaviour of electrolytes.
5. Describe the function and operation of electrochemical cells and list various types of electrochemical cells.
6. Demonstrate concepts in physical chemistry through problem solving and calculations of physical parameters.

Introduction to Biopharmaceuticals will provide the student with a broad overview of the Biopharmaceutical sector.

1. Demonstrate knowledge of the various technologies and disciplines that contribute to Biotechnology and Biopharmaceutical drug target discovery.
2. Identify and describe the different types of Biopharmaceutical products including proteins, antibodies, hormones, nucleic acids etc.
3. Explain the fundamental techniques of genetic engineering and provide examples of their use in the production of bioproducts.
4. Evaluate cell models for expression of exogenous gene products and explain the process of gene expression and regulation within these systems.
5. Effectively communicate scientific knowledge in an appropriate format.

This module further enhances aspects of organic chemical synthesis building on techniques covered in semester 1.

1. Recognise a range or organic functional groups and their reactivity

2. Demonstrate competence in the practical application of a range of synthetic organic chemical techniques.

3. Calculate chemical yields (theoretical, actual and percent), perform product reconciliation and explain losses

4. Demonstrate the ability to maintain a proper laboratory notebook, which includes clear descriptions of original data, observations and experimental procedures

5. Evaluate the risks associated with an experiment and understand how to mitigate against such risks

This course provides a theoretical and a practical introduction to inorganic chemistry. Fundamental aspects of inorganic chemistry relevant to pharmaceutical science are presented in the theory component of the module. The module develops the ability to carry out inorganic chemistry analytical techniques with confidence and with a high level of accuracy and precision.

1. Describe the basic concepts of inorganic chemistry including atomic number, atomic mass, atomic orbitals and electronegativity values

2. Describe the concepts of molecular bonding including models such as MO theory and VSEPR

3. Describe chemistry concepts related to acids, bases and ions in solution.

4. Demonstrate understanding of special topics such as catalysis, coordination chemistry and/or electron transfer.

5. Demonstrate ability to work safely in a chemical laboratory.

6. Perform inorganic chemistry analytical techniques.

7. Record data of analytical work and write concise experimental reports.

8. Analyse experimental data and draw conclusions on validity of data.

Introductory analytical techniques building on chemistry 1 and chemistry 2. The course introduces the student to fundamental chemical analytical techniques with a focus on chemical structures, concentration terms, classical and instrumental methods of determining qualitative and quantitative data. This module covers volumetric analysis including the application of primary and secondary standards. The module provides an introduction to instrumental techniques, such as, infrared spectroscopy, ultraviolet visible spectroscopy, atomic spectrometry, electroanalytical and chromatography.

1. Explain the purpose of most common analytical tests and describe fundamental strategies for the performance of classical and instrumental chemical analysis.

2. Explain the fundamental principles of a range of instrumental and classical methods of analysis.

3. Calculate chemical compositions from raw instrumental and noninstrumental analytical data and express chemical compositions in a range of concentration units.

4. Interpret qualitative data and ascertain chemical structures from analytical measurements.

5. Evaluate the reliability of analytical data using simple statistical and quality control techniques.

The aim of this module is to introduce the student to both the theory and practical aspects of microbiology related to the production of a range of biomedical products, including pharmaceuticals, medical devices and immunodiagnostic materials. Students will be provided with the opportunity to acquire knowledge of the subject matter through a variety of lecturer led activities and self-directed study. Such activities will include traditional and interactive lectures, problem solving and revision tutorials and laboratory practical classes. Theoretical and practical problems will be employed to assist students in the development of their analytical and problem solving capabilities.

1. Understand microbial ecology and its relationship to biomedical products manufacture.
2. Understand the importance of environmental monitoring as a regulatory and quality control requirement.
3. Collect, manipulate and interpret numerical data relating to microbiological analysis.
4. Understand the importance of, and work in compliance with, health and safety policies and good laboratory practice as it pertains to microbiology laboratories.
5. Be able to design and execute experiments, systematically collect and analyze data, identify sources of error, and interpret the results and reach logical conclusions.
6. Operate basic laboratory instruments used in industrial microbiological monitoring.
7. Cooperate and work effectively with peers and be able to demonstrate a commitment to the process of developing such skills.

This module details the diverse array of manufacturing processes & equipment employed in the pharmaceutical industry, in combination with the product packaging techniques. Additionally, it provides the student with a broad understanding of the various types of medical devices available and the modes and methods of manufacture.

1. To detail the mainstream systems and equipment used for generation of EP and USP grade water for Pharm/Biopharma production and manufacture.
2. To demonstrate a knowledge of the various information technology applications operating in the pharmaceutical industry.
3. To distinguish how non sterile Pharma/cosmetic products are manufactured, processed and the packaging options/requirements suited to each type of formulation.
4. To describe the methods to ensure the sterility of pharmaceutical preparation to the point of primary container closure selection and processing.
5. Contrast solid dosage form production techniques, from dry powder mixing to finished dosage formation and the packaging methods and requirements.
6. Demonstrate a knowledge and understanding of the medical device industry and the main product types currently being manufactured.

This course aims to provide the student with a broad understanding of the various aspects of the biomanufacturing process. The module will explore the technologies employed during upstream, downstream, formulation, fill-finish and delivery of biopharmaceuticals.

1. Identify and evaluate the key factors that are involved in upstream and downstream bioprocessing.

2. Identify key challenges involved in the formulation of biopharmaceuticals and explain the principal stages of sterile fill-finish operations.

3. Demonstrate knowledge of the key elements in a systematic approach to Biopharmaceutical Process Validation.
4. Compare routes of delivery for biopharmaceuticals (e.g. pulmonary, parenteral, transdermal) and evaluate current and novel drug delivery systems designed for biopharmaceuticals.
5. Recognise ethical and regulatory issues relating to the biopharmaceutical industry.

This module provides the student with an understanding of the chemistry behind (i) the structure of some selected groups of organic chemical molecules relevant to pharmaceutical and chemical industry and (ii) the intermolecular forces and chemistry behind liquid / solid / gas interfaces that give rise to their characteristic properties.

1. Name, identify and recognise the structure of a range of selected organic groups of molecules that are relevant to the pharmaceutical and chemical industry, including their structure, stereochemistry and synthesis.

2. Demonstrate knowledge of interfacial chemistry at the liquid / gas / solid boundaries.

3. Relate the concepts of interfacial chemistry and the functions of the organic groups covered in the module to their role in pharmaceutical and chemistry related applications.

4. Demonstrate numerical and problem solving skills to examine properties and illustrate examples relevant to the content of the module.

Through team problem based project work, this module addresses written and spoken communication of scientific information and emphasises personal and professional development skills for students including self awareness, interpersonal skills, interview skills, organisation and project management skills.

1. Identify and assess own skill set in relation to graduate opportunities.

2. Establish and demonstrate active pursuit of career goals.
3. Manage, report and deliver a scientific team project assignment.

4. Write a fully referenced technical report.
5. Demonstrate awareness of own responsibilities and individual contribution to successful teamwork.

This course is designed to provide an introduction to a range of statistical tools of relevance to scientists. Specific topics include an overview of statistical distributions, significance testing, uncertainty determination, linear regression and experimental design. The application of statistics for quality control and practical experience in the application of statistical features in the widely available Microsoft Excel is particularly emphasised.

The teaching methods used will be a combination of lectures, self-study, labs, tutorials, and any combination of discussion, case study, problem-solving exercises and computer-based learning.

1. Describe basic statistical terms which are of relevance to the area of analytical science.

2. Graphically display and numerically summarise data using appropriate tables, graphs and measures of centre, spread and position.

3. Explain and apply concepts of basic probability including, conditional probability, Bayes’ theorem, independent events and counting formulae;

4. Make interferences about population parameters using sample statistics using confidence interval estimates and tests of statistical hypotheses

5. Describe the application of statistics to sampling, quality control, analytical method validation and experimental design.

6. Use an appropriate method for analysing relationships between variables in a dataset

This module aims to provide the student with an understanding of the techniques employed in the early phase of research & development, in which pre-formulation studies focus on assessing the physical and chemical properties of a drug molecule that affect the molecules performance and activity. This provides important information for formulation design or supports the need for molecular modification prior to the compounding process that will assist in developing a stable, safe and effective formulation with maximum bioavailability.

1. Report on the terminology and concepts to establish the physicochemical parameters of a new/existing drug entity

2. Describe the thermodynamics of Colloidal Systems and the stability of dispersed systems
3. Illustrate the principles to determine a molecules physical characteristics, kinetic stability

4. Examine methods to establish a compounds compatibility with common excipients

5. Explain different processing strategies to support the dosage form design, drug processing and storage

This module aims to provide the student with an in-depth understanding of the fundamental activities and processes underpinning the formulation design, the bulk product manufacture and quality control activities of the primary pharmaceutical dosage forms (formulations).

1. Summarise the process and main objectives in designing and developing a formulated drug product.
2. Illustrate product profiles for a selection of dosage forms on the market including biopharmaceuticals.
3. Select and justify appropriate excipients for use in various conventional dosage forms.
4. Outline and Discuss the production activities, key process parameters and quality attributes specific to the manufacture of some major conventional dosage forms.

5. Identify relevant compendial tests and specifications for QC of conventional dosage forms.

6. Propose and prepare appropriate pharmaceutical formulation based on end use and relate preformulation activities to dosage form design, development and manufacture to solve formulation problems

7. Demonstrate an awareness of current advances in drug delivery and formulation Design.

8. Generate and follow Standard Operating procedures (SOP’s) in the execution of key manufacturing and QC processes

This module will demonstrate the importance of the systems approach both to quality and manufacturing within the highly regulated pharmaceutical sector. systems such as ISO 9000:2015 and ISO17025:2017 will be examined and topics such as document and product traceability will be analysed.

1. Evaluate the development and importance of Quality System Standards.
2. Identify the principal requirements of a Quality System.
3. Evaluate the benefits of the ISO 9000:2015 and ISO17025:2017Quality Systems.

4. Illustrate the importance of documentation as required by a Quality System.
5. Discuss the importance of Good Manufacturing Practice in a regulatedenvironment.

This module involves the synthesis of a range of Active Pharmaceutical Ingredients and associated regulatory aspects of the process.

1. Demonstrate competence in the application of a range of organic chemical synthetic techniques to the production of some common active pharmaceutical ingredients.
2. Analyse some standard synthetic methods and use these to generate manufacturing documentation in line with cGMP.

3. Determine quantities of starting materials as well as relevant glassware and equipment required for each synthesis

4. Generate and follow Standard Operating Procedures (SOP’s) in the use of some standard laboratory equipment .

5. Record and report on the synthetic method, including any deviations or variations to the process.

6. While working as a member of a group, evaluate the risks associated with each synthetic method and understand how to mitigate against these risks

This module addresses the essential practical and theoretical aspects of pharmaceutical analysis with a particular focus on separation science.

Students will engage in testing and reporting on the quality of a selection of pharmaceutical APIs and finished products using both compendial and non-compendial methods with due consideration to GMP throughout.

The module also addresses the issues of quality within measurements and also addresses aspects of sample preparation and pre-treatment.

1. Describe the purpose of the most common analytical tests carried out in the context of pharmaceutical manufacturing and quality control.

2. Relate key structural and physicochemical properties of pharmaceutical compounds to their analysis: eg appropriate analytical techniques, sample preparation and analytical conditions.

3. Identify suitable sample preparation techniques for a variety of pharmaceutical samples.
4. Explain the chemistries of some of the phases used in instrumental chromatographic techniques.
5. Explain what is meant by a valid analytical method and the steps taken to ensure validity in analysis.

6. Perform qualitative and quantitative laboratory analyses on Pharmaceutical APIs and Finished Products using a selection of compendial and non-compendial methods and with due consideration of GLP/GMP

7. Interpret data from qualitative and quantitative chromatographic determinations in relation to a stated test hypothesis or quality specification.