This module aims to provide students with an overview of active pharmaceutical ingredients, in particular, synthetic actives and their methods of analysis ranging from identification to quality control tests. The active Pharmaceutical Ingredient (API) section of this module will provide students with an understanding of the principles involved in chemical synthesis, with particular emphasis on the synthesis of active pharmaceutical ingredients, including some of the principal synthetic routes involved, the importance of stereochemistry, functional group interconversion and orientation theory in drug synthesis. The Pharmaceutical Analysis section will enable students to explain various analytical test methods used in a pharmaceutical/biopharmaceutical quality control laboratory to assess the raw material, in-process samples, and finished active and final product.

1. Appraise the relationship between structure and reactivity of a range of aliphatic and aromatic organic compounds.
2. Evaluate the importance of reaction mechanisms in chemical synthesis and be able to develop synthetic pathways to prepare specific organic compounds.
3. Establish the importance of stereochemical theory to explain structure and reactivity of pharmaceutical intermediates and related compounds.
4. Evaluate and understand the degradation pathways of pharmaceutical products and explain the significance and consequence of impurities which may be encountered during pharmaceutical product synthesis.
5. Interpret the analytical techniques used during the manufacture of pharmaceutical products including raw materials, bulk formulations and newly synthesised drugs, spanning instrumental and biological techniques.
6. Summarise the theory and use of various detection and separation systems in pharmaceutical analyses.
7. Compare and contrast various protein purification methods used in the pharmaceutical industry and assess the effectiveness of the purification processes.
8. Explain enzyme activity and types of enzyme inhibition as well as assessing the importance of enzymes and their inhibition in the pharmaceutical industry.

This module aims to provide the student with an overall understanding of the different types of dosages forms, their applications and the formulation processes used in their compounding. Both sterile and non-sterile dosage forms will be covered. The basic principles involved in formulation design and development including physicochemical characterisation and pharmacokinetic principles will be taught. This module will also include formulation of biotechnology molecules and advanced drug delivery technologies.

1. Compare and contrast, the function and characteristics of the different types of dosage forms including sterile dose forms.
2. Evaluate the significance of the presence of microorganisms in pharmaceutical raw materials, products and in the production environment.
3. Summarise the characteristics of microorganisms, including bacteria, fungi and viruses, with particular reference to those found as common contaminants in pharmaceutical production sources, properties, and identification.
4. Explain the principles involved in absorption, distribution and elimination of drugs and be able to apply pharmacokinetic methods to the development of various dosage forms.
5. Assess the influence of physicochemical characteristics of a drug on dosage form design and development.
6. Recommend methods to prevent contamination, using good product design and Good Manufacturing Practice including Aseptic technique and the design, classification, operation and monitoring of clean rooms.
7. Validate the major processes used in the formulation of various types of dosage forms including controlled-release, nanoparticulates and biotechnology products.
8. Critically examine the pharmacopoeial methods used for characterising finished dosage forms, including content and dose uniformity, dissolution and stability.

This module investigates the development of therapeutic agents and their subsequent application in clinical practice. Subject areas covered include drug discovery and design (including the application of quantitative structure activity relationships), drugs of natural origin, drug-target interactions, drug metabolism and pro-drugs and the chemical synthesis of therapeutic agents. Students also review the clinical use of therapeutic agents in patient populations with reference to their mechanism of action and linked to the pathophysiology of disease. Toxicology is also studied, with a particular focus on its relevance in the Pharmaceutical Industry.

1. Evaluate and explain the strategies, techniques and principles implemented in the discovery, isolation/synthesis, development and production of new drugs, from natural sources and synthetic chemical libraries.
2. Explain and interpret structure-activity relationships (SAR) and quantitative structure activity relationships (QSAR) in which physicochemical parameters (hydrophobicity, electronic, steric) are linked to biological activity of drug candidates.
3. Relate, on a molecular level, how drugs interact with enzyme and receptor targets.
4. Evaluate the types of reactions involved in drug metabolism, the problems associated with drug-drug interactions and the use of pro-drugs.
5. Analyse and utilise the fundamental principles of receptor pharmacology.
6. Recommend and choose using a systems based approach for pharmacological management and pathophysiology of the major clinical conditions.
7. Categorise the fundamental principles of toxicology as they apply to the Pharmaceutical Industry
8. Design a clinical trial programme to evaluate the safety and effectiveness of a new therapeutic agent.

This module provides a foundation in European and Irish legislation relating to the manufacture, storage and supply of licensed medicinal products. It provides an introduction to the manufacture, testing, packaging, labelling and associated regulatory aspects of Investigational Medicinal Products. This module provides an overview of the requirements and application process for clinical trial approval. It provides an overview of clinical study design and Good Clinical Practice. An outline of the role, professional duties and obligations of a qualified person is also covered.

1. Discriminate between Investigational Medicinal Products and marketed products and their associated regulatory requirements.
2. Explain the regulatory aspects including GMP principles relating to the manufacture, testing, packaging and labelling and release of Investigational Medicinal Products and licensed products.
3. Assess the various types of clinical trial designs, clinical trials application process including the investigational medicinal product dossier (IMPD).
4. Defend the principles of Good Clinical Trial Practice and their purpose.
5. Categorise the IMPD information requirements relating to specific types of investigational medicinal products.
6. Interpret the European and Irish regulatory system relating to the manufacture, storage and supply of licensed medicinal products including the general structure of Directive 2001/83/EC as amended by 2004/27/EC and Directive 2001/82/EC.
7. Explain the main elements and organisation of the Application Dossier for marketing and manufacturing authorisation.
8. Appraise the roles and responsibilities of the qualified person, the manufacturer, the authorisation holder and wholesaler and regulatory agencies.

This module section reviews the main areas of pharmaceutical and Bio-pharmaceutical manufacture. It covers active, in-process and finished dosage forms, ancillary systems and facilities required. This will demonstrate the importance of the systems approach to quality management within the highly regulated pharmaceutical sector. Systems such as ISO and ICH approach to quality management will be examined with particular emphasis on ICH Q10, Q11 qnd Q12.

1. Appraise and evaluate the operation and validation of the various production processes typically used within a pharmaceutical facility.
2. Categorise the different designs and construction of modern pharmaceutical production facilities, and the ancillary systems employed by this manufacturing sector.
3. Interpret, defend and support the rules governing Good Manufacturing Practice as applied to the various operation processes within the pharmaceutical and bio-pharmaceutical industry.
4. Defend the development, evolution and importance of Quality Management Systems in general with special emphasis on Pharmaceutical Quality Management Systems.
5. Evaluate the principal requirements of a Quality System.
6. Argue the importance of documentation as required by a Quality System.
7. Assess the importance of the ICH Product Life Cycle approach to Quality Management.

This module explains the main areas of the operations management function. It discusses the current problems and provides new insights associated with Operations Management in dynamic, high technology services or manufacturing environments. It provides the students with the ability to design, analyse and apply experimental design theory to optimise process operations. The module presents an overview of the various packaging technologies suitable for the array of pharmaceutical products including the safety/security features and allows the students to analyse and select suitable packaging options for various products. The module includes a Project Management section covering the appraisal, planning, scheduling, execution, monitoring, control and evaluation of projects as related to pharmaceutical operations. New introduction of equipment, facilities, systems of production are covered.

1. Evaluate and critique the Operations Management functions of an organization.
2. Summarise an organisations lean philosophy and approach.
3. Design and evaluate experimental designs in order to optimise process operations.
4. Appraise and select packaging materials relating to their characteristics, applications for use and select appropriate packaging features for the safety/security of pharmaceutical products.
5. Assess project proposals using a variety of non-numeric, profitability and scoring models.
6. Perform the tasks required for the effective initiation of a project.
7. Compare and contrast the Functional, Pure Project, and Matrix forms of project organisation and select an appropriate organisational form for a pharmaceutical project.
8. Apply a variety of project planning tools and techniques for project management.

This module aims to equip participants with the requisite advanced knowledge, understanding and skills to carry out pharma/biopharma industry related research projects, using traditional and emerging research designs informed by a critical awareness of developments at the forefront of advancements, legislation and practice in the life science industry. This module consists of an individual research project, lectures and workshops and directed learning on research methods and ethics, data protection, cleaning and analysis, scientific writing, presentation skills and computer skills. Health and safety in the workplace aspects of their research work will be covered.

1. Compile a coherent research proposal demonstrating knowledge of study background based on relevant scientific literature and formulate an appropriate methodology for data collection and analysis.
2. Show proficiency in good research skills, analysis and critical thinking, using a range of appropriate data collection methods and accepted models of analysis.
3. Apply good ethical rigor with respect to their work.
4. Develop personal skills in time and project management to demonstrate effective execution of the research project.
5. Evaluate and appraise their work in a scientific manner, illustrating a critical understanding of the limitations of the method(s) selected.
6. Interpret and evaluate the various sources of information to draw a reasoned argument, consistent and coherent recommendations and conclusions from the research evidence.
7. Combine knowledge from relevant taught course modules where relevant to the outcomes/ discussion and conclusions of the research project.
8. Have added to the body of knowledge in the area of Industrial Pharmaceutical Science, reflect self-critically on the outcomes / conclusions of the enquiry and on the research process itself.
9. Optional dependant on the Project
Develop the skills to present and defend aspects of the research at seminars, conferences and vivas, communicate effectively on the objectives of the project and demonstrate these deliverables were met and milestones completed.