The Pharmaceutical Work Practice module aims to connect students learning from course studies to the "real world" of the pharmaceutical workplace and vice-versa. Through site visits, student conference, work placement experiences and /or industry related research projects, this class aims to tell many stories of the pharmaceutical industry in Ireland and globally so that students are exposed to The variety of activities/ potential work opportunities that exist in the industry The issues that may arise – technical, quality,

1. Demonstratea range of personal/professional competenciesrequired in a regulated Health Products research/development /manufacturing workplace.

2. Discuss the design and operational aspects of pharmaceutical manufacturing facilities relevant to the current global trade and regulatory context.

3. Critically reflect on own competencies in relation tospecific job or graduate study requirements,identify and address a relevant gaps(s)in skills/knowledge/competencylevel.

4. Propose and defend solutions to complex real/simulated workplace problems
5. Distinguish own role and contribution toteam based problem solving

This module aims to provide students with a knowledge and understanding of the various analytical methods used in biopharmaceutical analysis.

1. Describe antibodies andvaccines.Compare and contrast a diverse range of immunoassays and bioassays.

2. Compare and contrast various protein purification methods used in the (bio)pharmaceutical industry.

3. Evaluate and discuss analytical techniques including both instrumental and biological techniques used on (bio)pharmaceutical products.
4. Identify, discuss and employ various detection and separation systems used in (bio)pharmaceutical analyses.
5. Communicate and report the findings of experimental analysis in an individual and/or group format taking into consideration good laboratory practice.

This module covers aromatic chemistry topics, including the reactivity of benzene derivatives and a range of heterocyclic compounds. The importance of stereochemistry in a pharmaceutical environment is also examined, including such topics as stereoselectivity, stereospecificity and asymmetric synthesis. Molecular orbital theory leading to product determination in cycloaddition and electrocyclic reactions are also studied.

1. Evaluate the reactivity of a range of benzene derivatives.
2. Identify and appraise a range of heterocyclic compounds.
3. Describe stereoselectivity and stereospecificity.
4. Explain the basis of nucleoplilic and electrophilic substitution reactions.
5. Determine synthetic routes to a range of organic chemical compounds.

6. Use molecular orbital theory to explain the products obtained in some cycloaddition and electrocyclic reactions.

The aim of this module is to develop the student's ability to independently apply the knowledge, skills and competences they have acquired in the course, in the planning and completion of a final year project.

1. Source, select and critically evaluate the literature on a select topic related to pharmaceutical science.

2. Identify appropriate research questions or test hypotheses and designmethodologies, for data collection, collation andanalysis .

3. Independently Plan and Manage project activities to deliver a quality project according to agreed deadlines with minimum supervision.

4. Interpret data and/or literature findings in relation to a defined research question or a stated research hypothesis

5. Communicate the research in bothwritten and oral formsdisplaying competent scholarly writing and referencing according to standard conventions.

The module aims to develop core skills to be able to carry out basic research methodologies. These skills include the ability to describe and outline various principles of research and basic constructs in the research process, to plan a research project, to critically evaluate scientific information, to use bibliography software, and write a scientific report.

1. Describe the research process with specific reference to the pharmaceutical environment.

2. Differentiate and distinguish between qualitative and quantitative research methodologies.

3. Summarise, integrate, compare and show evidence of critical analysis of scientific papers.

4. Write a research proposal for an undergraduate research project in pharmaceutical science.

5. Communicate research findings effectively to peers.

This module expands on the key areas of the EMA/EU/Irish legislation and US legislation for medicinal products for human use. It also builds on previous knowledge of Eudralex, ICH, PICs, guidance documents relevant to the Pharma/Biomedical and Medical Device industry.

1. Demonstrate a detailed knowledge and understanding of the US and EU institutions, legal instruments, ICH process and workings of the EMA and FDA.
2. Source and evaluate the directives and annexes currently regulating pharmaceutical production, placing on the market, pharmaco-vigilance, PQRs, and product falsification within the EU.
3. Integrate knowledge and understanding of the marketing authorisation process, the variations procedures and Clinical Trial Legislation to evaluate relevant case studies.
4. Interpret EUDRALEX Volume 2 / ICH M4: Notice to Applicants documentation to allow presentation of module contents to peers.
5. Examine and evaluate Irish legislation pertaining to pharmaceutical products.
6. Demonstrate a knowledge of current Medical Device regulations/directives and notified bodies.

Pharmaceutical Operations Excellence details the philosophy, continuous improvement methods, systems and tools used in management of products, processes, services and supply chains to achieve excellence.

It considers business and operations strategy to inform decision making in planning, control and improvement, taking in lean thinking, six sigma and total quality management. Tactical issues include plant layout and structure, project management methods, production scheduling and control, inventory management, quality control and inspection, equipment utilisation and maintenance policies.

1. Describe the strategic importance of operations and how it relates to other business functions; evaluate performance objectives, product life cycle and the volume and variety effect and how these impact strategic decision making.

2. Demonstrate an awareness of the philosophy of operations excellence; analyse continuous improvement tools and datasets such as JIT, Lean, six sigma, statistical process control, FMEA and evaluate appropriate methodologies.

3. Demonstrate an understanding of the concepts and methods related to designing and managing a pharmaceutical operations facility including job design, process and product design, supply network design and formulate designs for process flow and supply network location.

4. Appraise methods for planning and control in terms of supply chain, inventory and capacity management, scheduling and forecasting, and environmental factors.

5. Describe and evaluate the different Management Information Systems used in the pharmaceutical industry and examine emerging information, material and customer processing technologies.

This module is designed to introduce pharmaceutical pharmacology to students who are pursuing degrees scientific areas. Topics will include the basic principles of pharmacology and several major classes of therapeutic agents, with attention to their mechanisms of action by which drugs act and relates these to their overall pharmacological effects and clinical applications.

1. Gain a thorough understanding of Pharmacodynamics, the basic principles underlying drug action in the mammalian body and the Pharmacokinetics effect of the body on the drug molecule.
2. Describe the endocrine, nervous and excretory systems and the mechanisms of drug interaction with these systems.
3. Detail the MOA of Diuretics and Drugs Affecting Renal Function, Cardiovascular and Respiratory Pharmacology.
4. Describe the key factors involved in drug-receptor interaction and intracellular signalling mechanisms.
5. Detail the methods of Chemotherapy and modes of activity/selectivity, Structure Activity Relationship, Describe the mechanisms of transfer and of manipulation of the genetic elements involved in antibiotic resistance.
6. Demonstrate research techniques for obtaining drug information from drug references and other sources.

In this module, synthetic routes to a number of common active pharmaceutical ingredients will be examined as will the significance of drug impurity profiles associated with these routes.

The fields of Medicinal Chemistry and Pharmacognosy, with related processes and technologies for drug discovery and design will be introduced and links between a drugs structure, its physicochemical properties and pharmacological activity will be highlighted.

1. Describe some of the principal routes used in the preparation of common pharmaceutical products and important intermediates.
2. Explain the significance and consequence of impurities which may be encountered during pharmaceutical product synthesis and examine the characterisation and classification of such impurities.
3. Relate a drug’s chemical structure to its physicochemical properties and consequent entry, distribution, action and elimination from the body.
4. Interpret outcomes of simple QSAR studies and suggest suitable structural modifications to optimise potency.
5. Demonstrate an understanding of the approaches, processes and technologies employed by the field of Medicinal Chemistry in drug discovery and design.

6. Discuss the significance of natural sources for drug discovery and the challenges associated with generating new development candidates from natural sources.

This module introduces the regulatory requirement for GMP & compliance auditing, and the tools required by an effective auditor. It introduces quality risk assessment/management, CAPA and change control theory and practice. Additionally, this course outlines the various aspects of process and support systems validation utilised in pharmaceutical facilities. It will deal with the various risks inherent in pharmaceutical processing technologies and how the application of effective validation methodologies assists in the control and management of such risks.

1. Interpret and explain the relevance of auditing as a means of monitoring the production of safe and efficacious pharmaceutical products in a GMP environment.
2. Describe the various auditing techniques available and the regulatory basis for GMP/compliance auditing and describe the concept of calibration, Identify, assess and analyse breaches of GMP, change control and select appropriate CAPA activities

3. Describe the key elements and methodologies utilised for validation with particular emphasis on pharmaceutical processes and the product life cycle including CPP & CQA.
4. Outline the overall concept of risk management and how the application of risk assessment and management tools can enable these risks to be gauged and managed.
5. Identify the main steps involved in the qualification of pharmaceutical equipment, integrating processing equipment, cleaning systems, filtration systems, ancillary service facilities and utilities such as cleanrooms, sterilisation and Purified water systems. .

The aim of this module is to develop the student's ability to independently apply the knowledge, skills and competences they have acquired in the course, in the planning and completion of a final year project.

1. Source, select and critically evaluate the literature on a select topic related to pharmaceutical science.

2. Identify appropriate research questions or test hypotheses and designmethodologies, for data collection, collation andanalysis .

3. Independently Plan and Manage project activities to deliver a quality project according to agreed deadlines with minimum supervision.

4. Interpret data and/or literature findings in relation to a defined research question or a stated research hypothesis

5. Communicate the research in bothwritten and oral formsdisplaying competent scholarly writing and referencing according to standard conventions.