This module pertains to the manufacture of modern biologic products and focuses on various aspects of a typical biopharmaceutical production process such as cell culturing, upstream and downstream processing, biopharmaceutical analysis, formulation, lyophilisation, fill, finish and packaging, The module will also focus on emerging trends in biopharmaceutical manufacturing such as continuous bioprocessing and the move towards the use of single use technology in biopharmaceutical manufacturing.

1. Illustrate and implement an understanding of the key steps involved the delivery and formulation of Biopharmaceuticals

2. Evulateand critical appraise thetechnologies, processesand the technical parameters pertinent to cell culture, upstream and downstream processingwith emphasis on the emergence of technologiessuch as continuous manufacturing and single use technologies for biopharmaceutical manufacturing.

3. Analyse and apply knowledge of the key parameters in biopharmaceuticallyophilization, fill, packaging and labelling.

4. Corroborate an indepth knowledge of the key parameters in biopharmaceutical analysis.

This module reviews the key regulatory requirements for (bio)pharmaceutical product development, production and marketing. It addresses the role of quality management in determining key factors such as efficacy, purity and safety. It describes the ISO 9000 quality standard requirements of biopharmaceutical manufacturing and addresses the role of ISO 9000 certification in achieving these standards. It describes the difference between quality standards and international regulatory requirements and how quality management is associated with regulatory compliance. It addresses the regulatory requirements of various international regulatory authorities such as the FDA and EMA, National Authorities (i.e..HPRA) and describes the role of the more general ICH guidelines in meeting regulatory requirements.

1. Demonstrate a clear understanding of the role of quality assurance throughout the lifecycle of a biopharmaceutical productand identify key elements monitored by the quality control system in the manufacture of a biopharmaceutical drug.

2. Evaluate the regulatory demands of agencies such as the European Medicines Evaluation Agency (EMA) and Food & Drug Administration (FDA) in terms of the development, production, characterisation and evaluation of biopharmaceutical products

3. EvaluateCritical Quality Attributes (CQA) for biopharmaceutical manufacturing and critically analyse CQAs that demonstrate compliance with regulatiions for different types of biopharmaceuticals.

4. Analyse the role of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH) in regulating biopharmaceuticaldrugs and apply QbD principles to the step-by-step development of a purification process for a biopharmaceutical drug

Innovation is a key element in successfully growing business and competing in an ever-changing global environment. This module provides learners with an understanding of innovation at individual and firm level. An appreciation of the ever-changing macro and micro environments and stakeholder interest for contemporary organisations will be integral to the module.

Learners will appraise different approaches to innovation. A key focus will be the drive for business growth in today's rapidly changing business landscape. The development of effective organisation-wide strategies in the successful management of innovation in any industry.

1. Demonstrate the economics of innovation and implications of the macro environment and stakeholder interests in successfully driving business growth.

2. Appraise effective approaches to innovation.

3. Establish and implement organisation wide strategies in the management of innovation.

4. Explore approaches for enhancing organisational creativity.

5. Assess the importance of people, culture and organisation in the effective management of innovation.

Effective leadership is needed to understand, predict, plan and communicate the nature of organisational change and manage the response. This module explores various opportunities and challenges associated with leading and managing organisational change. Through the learning outcomes mentioned below, learners will be equipped with the knowledge, skills and attitudes necessary to effectively lead and collaborate with teams in a variety of organisational settings. It fosters collaborative engagement through the understanding of cross-functional teams within an organisation.

1. Demonstrate an understanding of leadership theories and concepts.

2. Develop essential and ethical leadership skills/practices, while enhancing personal leadership development

3. Apply leadership strategies to diverse/challenging situations

4. Foster effective team dynamics, by identifying and leveraging the strengths of team members to achieve collective goals.

5. Apply effective strategies for team building and employee engagement.

The curriculum aims at providing the students with the latest thinking and practice in strategic marketing and communications, with a particular twist on marketing of innovation, growth and sustainable performance.

1. Critically appraise the role of strategic marketing andcommunications in growing sustainable organisational success in a variety of global markets and business environments.

2. Analyze the business market environment, market trends, and the concept of consumer behaviourto inform strategic decision-making.

3. Identify and critically evaluate marketing data and marketing information sources and interpret their impacts on strategic marketing and communication issues.

4. Analyze the theory ofmarket segmentation,target marketing, positioning strategies and the concept of value propositions.

5. Select from the toolkit of marketing concepts and analytical frameworks to formulate strategic marketing plans and integrated communication plans.

This module is designed to introduce learners to the area of accounting and financial management. It looks in detail at what financial management is, its relationship to financial accounting and management accounting, the budgeting process, capital investment appraisal, the importance and management of working capital, and finance and investment decision-making based on accounting statements. The module is designed to take a high level view of the individual topics to facilitate those working in non-financial management positions in industry.

1. Have knowledge pertinent to financial management and an in-depth understanding of its importance in the business and corporate environment.
2. Demonstrate in-depth knowledge and understanding of the budget process in the preparation and interpretation of cash and integrated budgets.
3. Apply knowledge and understanding of capital investment decisions, including various appraisal techniques, supporting managerial decision-making.
4. Recognise and collate the information necessary for a variety of working capital management scenarios.

5. Analyse and interpret financial statements for the purposes of investment decisions.

The module introduces the concepts of operational excellence and examines their applications to the Life Sciences. This module aims to give the student the necessary skills to plan and implement a range of Six Sigma programme activities in a workplace environment.

The module will focus on the tools & techniques required to reduce process variability and thereby achieve Lean Six Sigma in manufacturing and ensure continuous process improvement.

1. Capitalise on the synergy between Lean and Six Sigma and construct an enterprise wide view of their application in the Life Science sector.

2. Develop and lead the implementation of a Lean Six Sigma program activity.

3. Recommend/Implementstatistical tools fromthe Six Sigma Define Measure Analyse Improve Control (DMAIC) toolkit for process improvement.

4. Evaluate and apply appropriatestrategic and tactical design tools (DFSS).

This module aims to provide learners with a broad understanding of Validation in the Biopharmacuetical manufacturing context, including Process, Equipment, Cleaning, Automated System and Test Method Validation.

1. Investigate the regulatory basis for Validation and the relatedrequirements of the (Bio)pharmaceutical sector from regulatory bodies.

2. Communicate the key steps required for anyValidation and fully comprehendthe underpinning principles of specification and verification.

3. Participate and add value as ateam member in industry on multiple types of Validation projects, e.g.Process, Equipment, Cleaning, Automated System orTest Method Validation.

4. Implement the principles of Validation to design and develop Validation documents.

5. Apply risk management and change control to Validation activities and Validated entities, e.g. Process, Equipment, Test Methods.

6. Determine and assess the key validation characteristics of a test method and factors that influence test method variability.

The project should take the form of a proposal for the development of a medical technology (biopharmaceutical or medical device product) to prevent, treat or diagnose a specific medical condition. The student will undertake a literature review to source information on the target condition and current therapies for the treatment of the disease. Based on this information and the student's knowledge gained through the programme, the student should propose an alternative product/technology, for prevention, treatment or diagnosis of said medical condition. Thereafter, students should include a detailed overview of the design, function, clinical trials, manufacturing, marketing and financial strategy of their proposed product.

1. Lead the development of a proposal for the development of a novel medical technology product.

2. Critically evaluate and reviewliterature (and other relevant, reliable sources) using appropriate keywords and databases.

3. Synthesize and collate relevant information from the programme modules to apply their knowledge to a current medical concern and the proposed design, manufacture, marketing and financial strategy of medical technology.

4. Communicate results of the reviewin written and oral forms, demonstrating critical analysis, synthesis and organisation of knowledge.