Advanced Pharmaceutical Science 1

PHAR62780 Advanced Pharmaceutical Science 1 30 Semester 1 Postgraduate Taught Level 7 Helen Callaby Unit coordinator Victoria Gibson Unit coordinator Beverley Ellis Unit coordinator Charlotte Ollerenshaw Unit coordinator Elizabeth Orr Unit coordinator Ruth Barnes Unit coordinator Emma Davies Unit coordinator Sue Renn Unit coordinator Pharmacy 1 FHEQ level (Framework for Higher Education Qualifications) ' Masters/Integrated Masters P4 ' European Credit Transfer & Accumulation System Rating : 15.0 This unit allows students to select THREE optional 10 credit units to create their 30-credit unit in Advanced Pharmaceutical Science.Students can choose from:<ul><li>Aseptics</li><li>Radiopharmacy</li><li>Production</li><li>Quality Control</li><li>Advanced Quality Assurance</li><li>Role of the Qualified Person (QP)</li><li>Pharmaceutical Medical Gases</li><li>Clinical Trials</li><li>Preparation for Practice</li><li>Research methods</li></ul> Radiopharmacy<ul><li> Explain the role of the Clinical Scientist in Pharmaceutical Science in the diagnosis and treatment of disease using radiopharmaceuticals, including the contribution to patient management, patient safety and patient-centred care.<ul><li>Pharmaceutical quality systems</li><li>Aseptic processes</li><li>Radiation safety</li><li>Radiopharmaceutical chemistry</li><li>Uses of radiopharmaceuticals</li><li>Legislation and guidance</li><li>Routine procedures used in hospital radiopharmacy</li><li>The organisational and financial aspects of a commercial radiopharmacy</li></ul></li><li>Explain the commonly used diagnostic and therapeutic radiopharmaceuticals.<ul><li>Uses, properties, chemistry, mechanisms of action, interactions and quality control</li><li>Indications for different radiopharmaceuticals</li><li>Radiopharmaceutical chemistry</li><li>Mechanisms of localisation</li><li>In vivo stability</li><li>Mechanisms of action</li><li>Interactions</li><li>Quality control methods</li></ul></li><li>Discuss the principles of PET imaging, commonly used PET radiopharmaceuticals and the organisation of a PET radiopharmacy.<ul><li>Cyclotrons</li><li>Principles of PET</li><li>Indications for PET radiopharmaceuticals</li><li>PET chemistry</li><li>Design of PET radiopharmacy departments</li><li>Workflow and organisation</li></ul></li><li>Critically appraise the preparation and clinical use of radiopharmaceutical and issues which may arise.<ul><li>Out of specification results</li><li>Generator problems</li><li>Interactions</li></ul></li><li>Discuss the importance of radiation protection and safe working in radiopharmaceutical preparation.<ul><li>Radiation safety</li><li>Monitoring</li><li>PQS</li></ul></li><li>Describe the functions of the different cell types routinely labelled in nuclear medicine, outline the different labelling methods and the most common clinical indications for these radiopharmaceuticals.</li><li>Discuss innovations and clinical trials within radiopharmacy <ul><li>Clinical trial requirements</li><li>Automation</li><li>New radiopharmaceuticals and techniques</li></ul></li></ul>Research MethodsResearch methods/approaches<ul><li>Differentiation between audit and research</li><li>Cohort studies</li><li>Qualitative </li><li>Quantitative</li><li>Systematic review</li><li>Meta-analysis</li><li>Sampling techniques</li><li>Clinical trials (pre-clinical to translational)</li><li>Epidemiological studies</li><li>Study design</li><li>Hypothesis generation and testing</li></ul>Ethical and governance research frameworks<ul><li>Good Clinical Practice (GCP)</li><li>Human research</li><li>Animal research</li><li>Innovation</li><li>Audit</li></ul>Research, audit and innovation process <ul><li>Literature searching and referencing</li><li>Innovation pathway (Invention, Evaluation, Adoption and Diffusion)</li><li>Idea generation</li><li>Patient/user involvement</li><li>Peer/expert review</li><li>Practical and financial criteria and constraints affecting research</li><li>Dissemination/implementation </li><li>Intellectual property</li><li>Quality assurance</li><li>Monitoring and reporting</li><li>Archiving</li><li>Roles and responsibilities of the research/innovation team</li></ul>Data analysis techniques<ul><li>Data validity, reliability and appropriateness </li><li>Application and interpretation of statistical techniques</li><li>Power calculations</li><li>Intention-to-treat analyses</li></ul>Clinical guidelines<ul><li>Evidence-based practice </li><li>Statutory and advisory regulatory bodies</li></ul>Research and innovation funding <ul><li>Sources of funding including research councils and charities</li><li>Grant applications</li></ul>Role of QP<ul><li>Applying to be become a QP</li><li>Pharmaceutical law and administration</li><li>Role and responsibilities of the QP</li><li>Quality Management systems</li><li>Mathematics and statistics used by the QP</li><li>Methods of microbiological testing</li><li>Role of the QP in Good Laboratory Practice</li><li>Control of pharmaceutical packaging</li><li>Control of active pharmaceutical ingredients</li><li>Role of the QP in clinical trials </li></ul>Advanced QA<ul><li>Regulatory Aspects<ul><li>The rules governing medicinal products in the European Community </li><li>Environmental Protection Act </li><li>Consumer Protection Act</li><li>EEC Directives </li><li>Statutory Instruments </li><li>Legislation and guidance relating to Health and Safety and handling hazardous medicinal products.</li><li>Clinical Trials directive and UK implementation </li><li>Official reports of relevance/importance </li></ul></li><li>Quality Assurance<ul><li>Quality Assurance, including management and organisational aspects </li><li>Quality Risk Management methodologies</li><li>Pharmaceutical Quality Systems</li><li>The role of the Qualified Person </li><li>Pharmaceutical Quality System Review. </li><li>Product Quality Review</li><li>Control Strategies</li><li>QA of Unlicensed Medicines</li><li>QA of ATMPs </li><li>Governance and Controls Assurance, Risk Management and Critical Control Point Analysis. </li><li>Defective products, complaints and recall procedures </li><li>Inter-relationships between disciplines involved in quality assurance </li><li>Role of the MHRA and CQC and liaison with MHRA and CQC</li><li>Managing the recall of a defective product.</li><li>Statistical methods for trending environmental monitoring.</li></ul></li><li>Product Licence Application<ul><li>Relationship of documentation to Product License data and any subsequent modifications. </li><li>The cost/benefit of taking products to Market Authorisation</li><li>Construction of application form and data required.</li></ul></li><li>Pharmaceutical Risk Management and Audit<ul><li>Risk Assessment & Management:<ul><li>Definitions</li><li>Types of Risk/Evidence of Risk/weighting Risk</li><li>Risks to product/Patients/staff/environment</li><li>Control of Risk - Minimising Risks - Transfer of Risk</li></ul></li><li>Overview of Pharmaceutical Risk Management & Audit:<ul><li>Quality Audits: participation and management of internal and external audits and inspections, follow-up, action plan preparation and assessment and reporting.</li><li>Roles of bodies involved</li><li>Links between National, Trust & Departmental agendas</li><li>Overview of legislation and standards </li><li>Relevant technical standards </li><li>Purchasing for Safety</li></ul></li><li>Audit Techniques:<ul><li>Attributes of the auditor</li><li>Tools of the Auditor (Vertical/ Horizontal Audit/Document Based/Problem Oriented/Random)</li><li>Compliance Monitoring/Assessment/Grading</li><li>Guidance for performing an EL audit</li><li>Supplier Audit and Inspection</li></ul></li><li>Risk Assessment Techniques<ul><li>Data handling & Statistical Calculations </li><li>Reports & Documentation</li></ul></li><li>Risk Reduction & Safe Systems of Work:<ul><li>Design of systems for Good Practice</li><li>Principles and key elements of good practice</li><li>Performance Indicators/Capacity planning</li><li>Systems Engineering Initiative for Patient Safety</li></ul></li></ul></li></ul>Aseptics<ul><li>Discuss and justify all standards, practices and quality assurance arrangements relating to aseptic preparation or aseptic manufacture of medicines and their application to patient safety and patient-centred care.<ul><li>Standards and guidance (licensed and unlicensed activity)</li><li>Organisational risk strategy</li><li>Process design</li><li>Quality assurance and release of finished products</li><li>Horizon scanning</li></ul></li><li>Critically analyse procedures required for outsourcing and sub-contracting services relating to aseptics.<ul><li>Outsourcing aseptic preparation</li><li>Sub-contracting services<ul><li>Cleanroom monitoring</li><li>Cleaning</li><li>Cleanroom clothing</li><li>Planned preventative maintenance (PPM)</li></ul></li></ul></li><li>Critically analyse pharmaceutical microbiological aspects of aseptic preparation and their application in the workplace.<ul><li>Microbiological monitoring requirements</li><li>Monitoring programs</li><li>Trending</li><li>Maintenance of aseptic environment</li></ul></li><li>Critically evaluate the design, commissioning and use of clean rooms/clean air devices.<ul><li>Ensuring all relevant standards are met</li><li>Cleanroom design and construction</li><li>Equipment design and construction</li></ul></li><li>Critically evaluate process and operator validations</li><li>Discuss human factors and how it relates to errors, deviations and CAPA.</li><li>Apply integrative knowledge of the formulation, stability and preparation of specialist, aseptic dose forms.<ul><li>PN</li><li>Gene therapy</li><li>ATMPs</li></ul></li><li>Investigate emerging therapies and technologies related to aseptic services.</li><li>Troubleshoot equipment and preparation issues.<ul><li>AHU</li><li>Clean air devices</li><li>Product preparation issues</li><li>Trending issues</li></ul></li><li>Environmental monitoring </li></ul>Clinical trialsThis unit engages the learner in a series of activities, learning exercises and reflective materials to provide them with an awareness of the effective management of clinical trials within the NHS research department, clinical trials unit and contract research organisation settings.It builds upon the learning about the context and requirements for clinical trials in the introductory unit ‘An introduction to clinical trials’ to empower the learner to reflect on the additional challenges that will arise when delivering clinical trials in these particular The advanced pharmaceutical science unit aims to develop students’ knowledge and understanding which was gained in Year 1. Year 2 of the programme, which comprises two advanced pharmaceutical science 30 credit units, allows students to specialise in specific areas of pharmacy technical services and leadership.RadiopharmacyTo build on the background knowledge provided in Introduction to Radiopharmacy (PHAR61730 - Introduction to Pharmaceutical Science 2). Students will gain an in-depth knowledge of how to operate at a much higher level within a radiopharmacy dealing with complex issues that may arise. They will also learn of novel drug development and imaging modalities.Research MethodsThe Research methods module will deliver the learning to enable students to undertake an evidence-based literature review, critically appraise the output, draw appropriate conclusions and report the findings, and where appropriate, use the findings to inform a research project.The Role of QPThis unit develops the student’s understanding of the role and professional duties of the QP within the NHS and industry environments. The module delivers core knowledge required on the pharmaceutical law and regulations applicable to the manufacture of pharmaceuticals and provides students with an appreciation of the process required to become a registered QP in the UK.Students learn the skill to apply all the elements of the QP study guide in their workplace. With sufficient practical experience after the unit students should have the skills to be assessed for formal QP status.The module will provide students with the core knowledge to identify, assess and manage the responsibilities of a QP within the pharmacy technical environment. The module will incorporate the relevant national standards and legislation that apply within this area of practice and introduce them to the use of common tools and strategies used in pharmaceutical environments.Advanced QAThe unit builds on the knowledge gained in the Foundations of PTQA unit in year 1. This will assist students in further developing the knowledge to identify, assess and manage risks within the pharmacy technical environment and to carry out quality assurance audits of services and service providers within this field.The unit provides the students with a higher understanding of pharmaceutical quality assurance, appropriate for more senior roles or for students considering taking up a position in QA.  Students will engage with lecturers and reading material to gain a full understanding of the regulatory framework governing pharmaceutical preparation and manufacture within the NHS.It will also provide a fundamental understanding of Pharmaceutical Quality Systems (PQS), including audit and risk assessment methods and the operational benefits and challenges of a robust system.The unit will provide students with the core knowledge to identify, assess and mange risks within the pharmacy technical environment and to carry out quality assurance audits of services and service providers within this field. The module will incorporate the relevant national standards and legislation that apply within this area of practice and introduce them to the use of common risk management tools and strategies used in pharmaceutical environments. AsepticsThe Aseptics unit builds on the background knowledge provided in Introduction to Aseptics (PHAR61730 - Introduction to Pharmaceutical Science 2). Students will be able to explain the function and operation of equipment and clean rooms. They will know and understand commissioning procedures and be able to critically evaluate monitoring data and diagnose problems.Clinical TrialsThe unit aims to enable students to:< The students will be able to:Radiopharmacy<ol><li>Explain the role of the Clinical Scientist in Pharmaceutical Science in the diagnosis and treatment of disease using radiopharmaceuticals, including the contribution to patient management, patient safety and patient-centred care.</li><li>Critically evaluate commonly used diagnostic and therapeutic radiopharmaceuticals.</li><li>Discuss the principles of PET imaging, commonly used PET radiopharmaceuticals and the organisation of a PET radiopharmacy.</li><li>Critically appraise the preparation and clinical use of radiopharmaceutical and issues which may arise.</li><li>Demonstrate a critical awareness of radiation protection and safe working in radiopharmaceutical preparation.</li><li>Describe the functions of the different cell types routinely labelled in nuclear medicine, outline the different labelling methods and the most common clinical indications for these radiopharmaceuticals.</li><li>Discuss innovations and clinical trials within radiopharmacy.</li></ol>Research Methods<ol><li>Discuss and critically evaluate the context within which research, development, innovation and audit are undertaken to improve patient care, promote innovation and improve service delivery.</li><li>Describe, compare and contrast a range of research methods/approaches, including cohort studies, qualitative, quantitative, systematic review, sampling techniques and clinical trials.</li><li>Explain and justify current UK ethical and governance frameworks and processes spanning the conduct of human and animal research, innovation and audit.</li><li>Critically evaluate the literature/evidence base to identify a research question and create a new approach or technique to improve patient care or service delivery. </li><li>Discuss and justify the research, audit and innovation process from idea generation to dissemination/implementation, including patient/user involvement and intellectual property.</li><li>Describe and evaluate a range of data analysis techniques to ensure the validity, reliability and appropriateness to the research aim, design and conclusion.</li><li>Describe how clinical guidelines are produced and the concept of evidence-based practice, including the role of current statutory and advisory regulatory bodies.</li><li>Identify potential sources of research and innovation funding for healthcare science/Clinical Scientists.</li></ol>Role of QP<ol><li>Demonstrate and in-depth knowledge of the role and professional duties of the Qualified Person as defined by EU law.</li><li>Interpret the current pharmaceutical law and regulations and apply them to the manufacture of pharmaceuticals.</li><li>Apply the extensive body of knowledge required by the QP to the workplace.</li><li>Critically analyse processes and systems to assure the quality of pharmaceuticals and maintain patient safety.</li><li>Undertake a proactive approach in applying the theory of risk management to patient care. </li></ol>Advanced QA<ol><li>Discuss and critically evaluate the application of regulatory controls to pharmaceutical technology and Quality Assurance.</li><li>Discuss and critically evaluate the principles of Quality Assurance (QA) and EU Good Manufacturing Practice (GMP) and Pharmaceutical Quality Systems (PQS).</li><li>Critically evaluate manufacturing, Quality Assurance and Quality Control documentation.</li><li>Discuss in detail the health and safety aspects of Pharmaceutical Technology and Quality Assurance, including COSHH and the handling of hazardous medicinal products.</li><li>Describe and critically evaluate the routes to obtaining a Manufacturing Authorisation including the associated timelines. </li><li>Critically evaluate the process to be followed when recalling a product from the market.</li><li>Describe the contents of an electronic Common Te</li></ol> The students will be able to:Radiopharmacy<ol><li>Interpret stability data to determine the shelf life of the product.</li><li>Critically evaluate a range of microbiological and physical monitoring methods.</li><li>Critically appraise the impact of the radiopharmaceutical production process on the quality of clinical outcomes.</li></ol>Research Methods<ol><li>To synthesis, analyse and systematically combine information obtained from different sources to develop a defined original research question and then to address it through the development of a coherent research project.</li></ol>Role of QP<ol><li>Follow regulatory standards and guidance.</li><li>Critically review processes and procedures during audit.</li></ol>Advanced QP<ol><li>Follow regulatory standards and guidance. </li><li>Evaluate scientific and clinical literature and present appropriately.</li><li>Critically appraise concepts and measures of quality and quality assurance and their links with the effective and efficient management of resources and improvement of service delivery.</li></ol>Aseptics<ol><li>Interpret stability data to determine the shelf life of the product.</li><li>Critically evaluate a range of microbiological and physical monitoring methods.</li><li>Construct risk assessments on preparation activities.</li></ol>Clinical trialsCritically analyse, evaluate and where appropriate formulate an informed opinion about:<ul><li>Clinical trial management in the public sector and the differences and challenges compared to private sector clinical trials</li><li>National and international clinical research legislation and how it impacts project delivery in the NHS</li><li>The effectiveness of current systems and processes to streamline clinical trial applications, set-up and manage the future of clinical research in the NHS. </li></ul>Medical gases<ol><li>Critically appraise installations.</li><li>Analyse and interpret results.</li><li>Evaluate findings and make recommendations.</li></ol>Preparation for practice<ol><li>Evaluate budget and contracts data and present appropriately.</li><li>Critically appraise concepts and measures of training and management and their links with the effective and efficient management of resources and improvement of service delivery.</li></ol>Production<ol><li>Appraise and interpret information from different sources in order to develop a coherent critical analysis of issues relating to the practice and delivery of clinical pharmaceutical science services.</li><li>Critically appraise the impact of the pharmaceutical production process on the quality of the clinical outcomes.</li><li>Reviewing of technical agreements with suppliers and service providers.</li></ol>Quality Control<ol><li>Perform analytical method validation and equipment validation.</li><li>Interpret QC data and investigate questionable data/results.  </li></ol> The students will be able to:Radiopharmacy<ol><li>Work safely in the radiation environment.</li><li>Perform a range of radiopharmaceuticals.</li><li>Perform radiochemical purity testing on a range of radiopharmaceuticals and interpret results.</li><li>Interpret and analyse monitoring data and diagnose problems.</li><li>Assist with clean room commissioning and routine monitoring.</li></ol>Research Methods<ol><li>Work within the principles and practice of instruments, equipment and methodology used in clinical pharmaceutical science.</li><li>Support safe storage and distribution of medicinal products.</li><li>Identify validation requirements for any changes to processes. </li></ol>Role of QP<ol><li>Assess own education and experience with regard to the requirements for a QP and prepare a gap analysis as required.</li><li>Applying statistical methods to determine robustness or validity of data.</li></ol>Advanced QA<ol><li>Prepare technical documents; product specifications, investigation reports.</li><li>Prepare and assess risk assessments using a variety of tools and techniques.</li><li>Interpret complex data and report on the findings.</li><li>Prepare to perform an internal or external audit.</li><li>Identify shortcoming in existing procedure and recommend change.</li><li>Assess the impact of change.</li><li>Carry out thorough risk assessments using a variety of tools and techniques.</li><li>Identifying different types of risk.</li><li>Suggesting and implementing risk reduction measures. </li></ol>Aseptics<ol><li>Interpret and analyse monitoring data and diagnose problems.</li><li>Assist with clean room commissioning and routine monitoring. </li></ol>Clinical trials<ol><li>Analyse qualitative and quantitative data to determine their strength and validity.</li><li>Complete practical exercises to demonstrate an understanding of the application of knowledge derived from the course material</li><li>Engage in critically reflective practice as a process of continuous personal development. </li></ol>Medical gases<ol><li>Apply advanced skill in analysis of:<ul><li>Oxygen</li><li>Water</li><li>Nitrous oxide</li><li>Compressed air and oxygen concentrators</li><li>Contaminants.</li></ul></li><li>Identify test requirements for new installations and for routine testing.</li><li>Determine cause/fault in defective systems.</li></ol>Preparation for practice<ol><li>Interpret and analyse budget and contracts data and prepare reports.</li><li>Critically appraise training methods.</li><li>Critically discuss and evaluate the principles of managing small teams within an NHS department. </li></ol>Production<ol><li>Demonstrate professionalism and ethical awareness.</li><li>Apply the principles of EU Good Manufacturing Practice (GMP) to develop a safe new product.</li><li>Perform all manufacturing activities in accordance with requirements for Good Manufacturing Practice (GMP) and Pharmaceutical Quality Systems.</li><li>Work within the principles and practice of instruments, equipment and methodology used in pharmacy technical services.</li><li>Support safe storage and distribution of medicinal products.</li><li>Identify validation requirements for any changes to processes. </li></ol>Quality Control<ol><li>Work within the principles and practice of instruments, equipment and methodology used in pharmacy technical services.</li><li>Critically evaluate data and investigate anomalous results.</li><li>Identify validation requirements for any changes to processes.</li></ol>  The students will be able to:Radiopharmacy<ol><li>Effectively utilise a range of information sources.</li><li>Demonstrate capacity for self-learning and independent thinking and to utilise problem solving skills.</li><li>Demonstrate effective communication skills (verbal and written). </li><li>Be able to set priorities and link these with effective time management. </li><li>Critically evaluate their personal performance both as an individual and within a team.</li><li>Demonstrate skills in working collegiately and effectively with others as a member of a team.</li><li>Show appreciation of the way in which legislation, standards and quality management interface with normal working life.</li></ol>Research Methods<ol><li>The ability to plan and devise a framework and timetable for action and carry these out systematically, either for individual purposes or in a group context.</li><li>Project management; taking responsibility for and planning a project from beginning to end.</li><li>Selection and use of appropriate methods to find solutions. </li></ol>Role of QP<ol><li>Use effective negotiation skills.</li><li>Communicate difficult decisions.</li><li>Maintain a pragmatic approach during challenging debates.</li></ol>Advanced QA<ol><li>Read, interpret and apply standards and guidance to working practices.</li><li>Demonstrate professionalism and ethical awareness.</li><li>Communicate effectively with professional colleagues and service users.</li><li>Select and apply appropriate analysis or assessment techniques.</li></ol>Aseptics<ol><li>Effectively utilise a range of information sources.</li><li>Demonstrate capacity for self-learning and independent thinking and to utilise problem solving skills.</li><li>Demonstrate effective communication skills (verbal and written). </li><li>Be able to set priorities and link these with effective time management. </li><li>Critically evaluate their personal performance both as an individual and within a team.</li><li>Demonstrate skills in working collegiately and effectively with others as a member of a team. </li></ol>Clinical trials<ol><li>Critique information from a range of sources to formulate opinions.</li><li>Set up and conduct clinical trials in accordance with legislative requirements, demonstrating high level knowledge on a process-driven approach.</li><li>Network with key stakeholders in own organisation to drive processes forward based on knowledge gained through course participation.</li><li>Assess current working practices based on knowledge and experience gained and adapt working processes as necessary.</li><li>Prioritise and effectively manage time to complete work by required deadlines. </li></ol>Medical gases<ol><li>Effective communication with a multi-disciplinary team.</li><li>Efficient working under pressure.</li></ol>Preparation for practice<ol><li>Effectively utilise a range of information sources.</li><li>Demonstrate capacity for self-learning and independent thinking and to utilise problem solving skills.</li><li>Demonstrate effective communication skills (verbal and written). </li><li>Be able to set priorities and link these with effective time management. </li><li>Critically evaluate their personal performance both as an individual and within a team.</li><li>Demonstrate skills in working collegiately and effectively with others as a member of a team.</li></ol>Production<ol><li>Communicate effectively in a variety of settings with a range of individuals.</li><li>Use logical and systematic approaches to problem-solving and decision-making.</li></ol>Quality Control<ol><li>Project management; take re Radiophamacy<ol><li>A teaching block including face-to-face and online lectures, workshops and practicals.</li><li>E-Learning: evidence-based learning supported by course notes, video/audio lectures and discussion boards.</li></ol>Research Methods<ol><li>Online lectures and workshops.  </li><li>E-Learning: evidence-based learning supported by course notes, video/audio lectures and discussion boards.</li></ol>Role of QP<ol><li>A  teaching block including face-to-face and online lectures and workshops.</li><li>E-Learning: evidence-based learning supported by course notes, video/audio lectures and discussion boards.</li></ol>Advanced QA<ol><li>A  teaching block including face-to-face and online lectures and workshops.</li><li>E-Learning: evidence-based learning supported by course notes, video/audio lectures and discussion boards.</li></ol>Aseptics<ol><li>A  teaching block including face-to-face and online lectures and workshops.</li><li>Site Visits (where possible).</li><li>E-Learning: evidence-based learning supported by course notes, video/audio lectures and discussion boards.</li></ol>Clinical trialsStudents are provided with the learning material online. The learning material comprises 6 chapters covering the key areas to consider when conducting clinical trials for the NHS. Each chapter contains a number of exercises for students to check their learning as they progress through the unit. A reference list of further reading is provided for each chapter allowing the student to investigate the subject area more deeply, and the unit tutor is available to answer queries and provide guidance as required. The face-to-face workshop at the annual workshop event explores key areas of the unit through a range of hands-on exercises.Medical gases<ol><li>One week teaching block including workshops and practicals.<ul><li>The teaching component is provided by the Faculty of Engineering and Physical Sciences, Leeds and is delivered by experts in their field.</li></ul></li><li>E-Learning: evidence-based learning supported by course notes, video/audio lectures and discussion boards. </li></ol>Preparation for practice<ol><li>A teaching block including face-to-face and online lectures and workshops.</li><li>E-Learning: evidence-based learning supported by course notes, video/audio lectures and discussion boards. </li></ol>Production<ol><li>A teaching block including face-to-face and online lectures and workshops.</li><li>Site visits (where possible).</li><li>E-Learning: evidence-based learning supported by course note, video/audio lectures and discussion board.</li></ol>Quality Control<ol><li>A teaching block including face-to-face and online lectures and workshops.</li><li>E-Learning: evidence-based learning supported by course notes, video/audio lectures and discussion boards.  </li></ol> 0 Other 100% <figure class="table"><table style="border:1px solid hsl(0, 0%, 0%);"><tbody><tr><td style="border:1px solid hsl(0, 0%, 0%);">Assessment task</td><td style="border:1px solid hsl(0, 0%, 0%);">Length</td><td style="border:1px solid hsl(0, 0%, 0%);">How and when feedback is provided</td><td style="border:1px solid hsl(0, 0%, 0%);">Weighting with unit (if relevant)</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);" colspan="4">Radiopharmacy</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);">Written assignment</td><td style="border:1px solid hsl(0, 0%, 0%);">2,000 words</td><td style="border:1px solid hsl(0, 0%, 0%);">3 weeks after submission deadline</td><td style="border:1px solid hsl(0, 0%, 0%);">See PHAR61650/PHAR62780/PHAR62790</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);" colspan="4">Research Methods</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);">Project proposal</td><td style="border:1px solid hsl(0, 0%, 0%);">1,000 words</td><td style="border:1px solid hsl(0, 0%, 0%);">3 weeks after submission deadline</td><td style="border:1px solid hsl(0, 0%, 0%);">See PHAR61650/PHAR62780/PHAR62790</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);">Presentation on project proposal (formative)</td><td style="border:1px solid hsl(0, 0%, 0%);">10 minutes</td><td style="border:1px solid hsl(0, 0%, 0%);">3 weeks after presentation</td><td style="border:1px solid hsl(0, 0%, 0%);">PASS</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);" colspan="4">Role of QP</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);">Written assignment</td><td style="border:1px solid hsl(0, 0%, 0%);">2,000 words</td><td style="border:1px solid hsl(0, 0%, 0%);">3 weeks after submission deadline</td><td style="border:1px solid hsl(0, 0%, 0%);">See PHAR62780/PHAR62790</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);" colspan="4">Advanced QA</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);">Written assignment</td><td style="border:1px solid hsl(0, 0%, 0%);">2,000 words</td><td style="border:1px solid hsl(0, 0%, 0%);">3 weeks after submission deadline</td><td style="border:1px solid hsl(0, 0%, 0%);">100%</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);" colspan="4">Aseptics</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);">Written assignment</td><td style="border:1px solid hsl(0, 0%, 0%);">2,000 words</td><td style="border:1px solid hsl(0, 0%, 0%);">3 weeks after submission deadline</td><td style="border:1px solid hsl(0, 0%, 0%);">See PHAR61650/ PHAR62780/ PHAR61790</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);" colspan="4">Clinical trials</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);">Assessed discussion board</td><td style="border:1px solid hsl(0, 0%, 0%);">6 weeks discussion board</td><td style="border:1px solid hsl(0, 0%, 0%);">3 weeks after submission deadline</td><td style="border:1px solid hsl(0, 0%, 0%);">See PHAR62780/PHAR62790</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);" colspan="4">Medical gases</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);">Assignment</td><td style="border:1px solid hsl(0, 0%, 0%);">2,000 words</td><td style="border:1px solid hsl(0, 0%, 0%);">3 weeks after submission deadline</td><td style="border:1px solid hsl(0, 0%, 0%);">100%</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);" colspan="4">Preparation for practice</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);">Written assignment</td><td style="border:1px solid hsl(0, 0%, 0%);">2,000 words</td><td style="border:1px solid hsl(0, 0%, 0%);">3 weeks after submission deadline</td><td style="border:1px solid hsl(0, 0%, 0%);">See PHAR71880/PHAR62780/PHAR62790</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);" colspan="4">Production</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);">Written assignment</td><td style="border:1px solid hsl(0, 0%, 0%);">2,000 words</td><td style="border:1px solid hsl(0, 0%, 0%);">3 weeks after submission deadline</td><td style="border:1px solid hsl(0, 0%, 0%);">See PHAR71880/PHAR62780/PHAR62790</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);" colspan="4">Quality Control</td></tr><tr><td style="border:1px solid hsl(0, 0%, 0%);">Assignment</td><td style="border:1px solid hsl(0, 0%, 0%);">2,000 words</td><td style="border:1px solid hsl(0, 0%, 0%);">3 weeks after submission deadline</td><td style="border:1px solid hsl(0, 0%, 0%);">See PHAR71880/PHAR62780/PHAR62790</td></tr></tbody></table></figure> Provisional marks and feedback for coursework returned within 3 weeks after submission deadline.Exam marks and final marks returned after ratification at exam board. N Radiopharmacy<ol><li>Zolle, I (Ed)  2007 Technetium-99m Pharmaceuticals: Preparation and Quality Control in Nuclear Medicine. Berlin: Springer  ISBN-10: 3-540-33989-2 ISBN-13: 978-3-540-33989-2</li><li>Theobald, T. 2010 Sampson’s Textbook of Radiopharmacy 4th Edition. London: Pharmaceutical Press  ISBN-10: 0853697892  ISBN-13: 978-0853697893</li><li>ARSAC: Notes for guidance Online at <a href="http://www.arsac.org.uk/notes_for_guidance/">http://www.arsac.org.uk/notes_for_guidance/</a></li><li>Saha, G.B. 1998 Fundamentals of Nuclear Pharmacy 5th Edition.  New York: Springer Science and Business Media ISBN-10: 0387983414 ISBN-13: 978-0387983417 </li><li>Welch, M.J and Redvanly, C. S. (Ed) 2002 Handbook of Radiopharmaceuticals: Radiochemistry and applications. Chippenham: John Wiley & Sons Ltd  ISBN-10: 0471495603  ISBN-13: 978-0471495604 </li><li>Kowalsky, R and Falen, S.W. 2011 Radiopharmaceuticals in Nuclear Pharmacy and Nuclear Medicine 3rd Edition. Washington: American Pharmacists Association  ISBN-10: 1582121184  ISBN-13: 978-1582121185</li><li>Quality Assurance of Radiopharmaceuticals Online at <a href="http://www.bnms.org.uk/images/stories/UKRG/UKRG_QA_Apr-12.pdf">http://www.bnms.org.uk/images/stories/UKRG/UKRG_QA_Apr-12.pdf</a></li><li>Guidelines for the safe preparation of radiolabelled blood cells Online at <a href="http://www.bnms.org.uk/images/stories/downloads/documents/ukrg_blood_labelling_2009.pdf">http://www.bnms.org.uk/images/stories/downloads/documents/ukrg_blood_labelling_2009.pdf</a></li><li>Responsibilities of Chief Pharmacists for the purchase and supply of radiopharmaceuticals Online at <a href="http://www.bnms.org.uk/images/stories/downloads/documents/ukrg_purchase_responsibilities_2009.pdf">http://www.bnms.org.uk/images/stories/downloads/documents/ukrg_purchase_responsibilities_2009.pdf</a></li></ol>Research Methods<ol><li>Scientific review writing guidelines from: The Cochrane Collaboration (http://www.cochrane.org/resources/handbook/)</li><li>Mepham, B. Bioethics: an introduction for the biosciences.  2005. Oxford University Press.</li><li>Talbot-Smith A and Pollock A (2006) The new NHS: A guide: A Guide to Its Funding, Organisation and Accountability Routledge (London) </li><li>Bland, M. 2000. Introduction to Medical Statistics, 3rd Edition. OUP</li><li>Bowers, D, House, a, Owens. D. (2006) Understanding Clinical Papers. Wiley & Sons.</li><li>Rowntree, D. 2003. Statistics without tears: a primer for non-mathematicians. Allyn and Bacon, London.</li><li>Wardlaw, A.C. 2000. Practical Statistics for Experimental Biologists, 2nd edition. Wiley</li><li>Zar, H. 1998. Biostatistical Analysis, 4th Edition, Prentice</li></ol>Role of QP<ol><li>Volume 4 Good Manufacturing Practice (GMP) Guidelines, online at <a href="http://ec.europa.eu/health/documents/eudralex/">http://ec.europa.eu/health/documents/eudralex/</a><ul><li>Chapter 2 – EU Guidance on Good Manufacturing Practice</li><li>Annex 1 – Manufacture of sterile products</li><li>Annex 13 – Manufacture of Investigational Medicinal Products</li><li>Annex 16 – Certification by a Qualified Person and batch release</li></ul></li><li>Qualified Person documents:<ul><li>Guidance notes for applicants for QP status</li><li>QP study guide</li><li>Code of practice.</li></ul></li><li>TSET competencies of Qualified Persons.  A framework for individuals seeking nomination as a pharmaceutical Qualified Person.</li><li>Consultation Letter MLX275 – Recommendations for the Labelling and Packaging of Medicines. (Issued 21 Aug 2001 by SA Norton, MCA); together with the “Report to the Committee on Safety of Medicines from the Working Group on Labelling and Packaging of Medicines"<ul><li>Controls Assurance Standards for Medicines Management</li></ul></li></ol><st Lectures 60 0 240 Other Scheduled teaching and learning activities:<ul><li>Lectures and workshops</li><li>Self-directed study (web-based learning and activities on Blackboard)</li><li>Private study</li><li>Catch-up meetings and online Q&A</li><li>Summative assessment</li><li>Formative assessment.</li><li>Three-day residential summer school. (For Clinical Trials for the NHS option only.)</li><li>Face-to-face workshops with course tutors (Non-mandatory. For Clinical Trials for the NHS option only.)</li></ul>Pre-requisite units for specific options:<ol><li>Radiopharmacy (PHAR61730 Introduction to Radiopharmacy)</li><li>Advanced QA (PHAR61780 Foundations of PTQA)</li><li>Aseptics (PHAR61730 Introduction to Aseptics)</li><li>Production (PHAR61730 Introduction to Production & Quality Control)</li><li>Quality Control (PAHR61730 Introduction to Production & Quality Control)</li></ol>Contact hours:<ul><li>Radiopharmacy - 25 hours</li><li>Clinical Trials for the NHS - 0 hour (The option is delivered by distance learning. This unit will equate to 100 hours of learning. Seventy-five of these will be through the taught component. Twenty-five will be through directed learning and assessment.)</li></ul>