This module addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biological medicinal products such as those based on mAbs differ in certain respects from those for small-molecule products. This is because of the distinct characteristics of biologics, such as complex structure and susceptibility to variation during manufacture.
The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, typically hospitals, has to be evaluated, and the trial has to be set up at each site. This module describes the processes involved, focusing particularly on the role of a Clinical Research Associate (CRA) employed or contracted by the sponsor to monitor the trial.
This module provides an understanding of how clinical trials fit into the drug development process. It outlines the key historical events leading to the development of controlled clinical trials. It specifies the purpose of trials, outlines their features, and identifies codes and regulations that apply to them. Finally, it describes the environment of cost control in which the modern pharmaceutical industry operates.
Good Manufacturing Practice (GMP) is a set of rules for medicines manufacturers to follow so that their products are safe, effective, and of good quality. The rules may be written into law or set out in guidance documents from regulatory authorities. Regulators will not allow medicinal products to be placed, or to remain, on the market in their country unless the products can be shown to be manufactured in compliance with GMP. To this end, they carry out inspections of manufacturing plants. Companies that persistently commit serious breaches of GMP requirements have suffered huge fines.
The warehouse plays a crucial role in a medicinal products factory. This module explains the requirements of Good Manufacturing Practice (GMP) for the warehouse, and how to comply with them.
Pharmacokinetic (PK) and pharmacodynamic (PD) studies provide a bridge between science and medicine in the development of a drug. In this module we describe the role of in-vivo PK and PD studies in a drug development programme, set out the uses to which the findings can be put, and discuss their implications for clinical development and application for marketing approval.
Online modular laparoscopy course with theory and practical training. Assignments submitted for each module for progression on to the next.
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Getting Started The QUALIFI Level 7 Diploma in Psychology is designed to offer learners a comprehensive grasp of fundamental cognitive functions, including perception, executive functions, language, and attention, emphasising their significance within the realm of psychology. This course also focuses on equipping learners with practical skills essential for a successful career in psychology. Key Benefits Comprehensive Understanding: This qualification equips learners to explore the causes and development of mental health issues, including assessment and diagnosis. It takes a critical approach, considering biological risk factors and emphasising psychological and sociocultural factors. Statistical Proficiency: Students will develop a strong grasp of essential statistical techniques commonly used in psychological research. Practical application is facilitated through computer sessions where real-world research questions are presented, allowing students to use example data sets for analysis. Research Expertise: The qualification covers the entire research process, encompassing research techniques, ethical considerations, and scientific writing skills. The module "Issues in Scientific Research" introduces students to the intricate aspects of both theory and practice in research. Neuropsychological Insight: Learners will acquire knowledge of the neuropsychological dimensions of emotions and behaviour in healthy individuals and clinical populations. This provides valuable insights into the relationship between brain function and psychological processes. Career Pathways Upon successfully finishing the QUALIFI Level 7 Diploma in Psychology, learners can advance through further academic pursuits or by entering the workforce. Psychology Assistant with an estimated average salary of £26,473 per annum Mental Health Technician with an estimated average salary of £32,500 per annum Addiction Counselor with an estimated average salary of £37,593 per annum Behaviour Technician with an estimated average salary of £41,283 per annum About Awarding Body QUALIFI, recognised by Ofqual awarding organisation has assembled a reputation for maintaining significant skills in a wide range of job roles and industries which comprises Leadership, Hospitality & Catering, Health and Social Care, Enterprise and Management, Process Outsourcing and Public Services. They are liable for awarding organisations and thereby ensuring quality assurance in Wales and Northern Ireland. What is included? Outstanding tutor support that gives you supportive guidance all through the course accomplishment through the SBTL Support Desk Portal. Access our cutting-edge learning management platform to access vital learning resources and communicate with the support desk team. Quality learning materials such as structured lecture notes, study guides, and practical applications, which include real-world examples and case studies, will enable you to apply your knowledge. Learning materials are provided in one of the three formats: PDF, PowerPoint, or Interactive Text Content on the learning portal. The tutors will provide Formative assessment feedback to improve the learners' achievements. Assessment materials are accessible through our online learning platform. Supervision for all modules. Multiplatform accessibility through an online learning platform facilitates SBTL in providing learners with course materials directly through smartphones, laptops, tablets or desktops, allowing students to study at their convenience. Live Classes (for Blended Learning Students only) Assessment Time-constrained scenario-based assignments No examinations Entry Requirements The qualification aims to provide access without unnecessary barriers, and applicants should be at least 19 years old to apply. Non-native English speakers need an IELTS score of 6 or an equivalent language qualification. International applicants' qualifications will be checked for eligibility in UK higher education postgraduate programs. Additionally, applicants typically need to provide two references, with preference for academic concerns. Progression Achieving the QUALIFI Level 7 Diploma in Psychology provides learners with the opportunity to advance in the following ways: Pursuing the QUALIFI Level 8 Diploma. Enrolling in a university program to earn a Master's Degree. Entering into employment within a related profession. Why gain a QUALIFI Qualification? This suite of qualifications provides enormous opportunities to learners seeking career and professional development. The highlighting factor of this qualification is that: The learners attain career path support who wish to pursue their career in their denominated sectors; It helps provide a deep understanding of the health and social care sector and managing the organisations, which will, in turn, help enhance the learner's insight into their chosen sector. The qualification provides a real combination of disciplines and skills development opportunities. The Learners attain in-depth awareness concerning the organisation's functioning, aims and processes. They can also explore ways to respond positively to this challenging and complex health and social care environment. The learners will be introduced to managing the wide range of health and social care functions using theory, practice sessions and models that provide valuable knowledge. As a part of this suite of qualifications, the learners will be able to explore and attain hands-on training and experience in this field. Learners also acquire the ability to face and solve issues then and there by exposure to all the Units. The qualification will also help to Apply scientific and evaluative methods to develop those skills. Find out threats and opportunities. Develop knowledge in managerial, organisational and environmental issues. Develop and empower critical thinking and innovativeness to handle problems and difficulties. Practice judgement, own and take responsibility for decisions and actions. Develop the capacity to perceive and reflect on individual learning and improve their social and other transferable aptitudes and skills. Learners must request before enrolment to interchange unit(s) other than the preselected units shown in the SBTL website because we need to make sure the availability of learning materials for the requested unit(s). SBTL will reject an application if the learning materials for the requested interchange unit(s) are unavailable. Learners are not allowed to make any request to interchange unit(s) once enrolment is complete. To know about the Qualification Structure, please get in touch with us at: admission@sbusinesslondon.ac.uk Delivery Methods School of Business & Technology London provides various flexible delivery methods to its learners, including online learning and blended learning. Thus, learners can choose the mode of study as per their choice and convenience. The program is self-paced and accomplished through our cutting-edge Learning Management System. Learners can interact with tutors by messaging through the SBTL Support Desk Portal System to discuss the course materials, get guidance and assistance and request assessment feedbacks on assignments. We at SBTL offer outstanding support and infrastructure for both online and blended learning. We indeed pursue an innovative learning approach where traditional regular classroom-based learning is replaced by web-based learning and incredibly high support level. Learners enrolled at SBTL are allocated a dedicated tutor, whether online or blended learning, who provide learners with comprehensive guidance and support from start to finish. The significant difference between blended learning and online learning methods at SBTL is the Block Delivery of Online Live Sessions. Learners enrolled at SBTL on blended learning are offered a block delivery of online live sessions, which can be booked in advance on their convenience at additional cost. These live sessions are relevant to the learners' program of study and aim to enhance the student's comprehension of research, methodology and other essential study skills. We try to make these live sessions as communicating as possible by providing interactive activities and presentations. Resources and Support School of Business & Technology London is dedicated to offering excellent support on every step of your learning journey. School of Business & Technology London occupies a centralised tutor support desk portal. Our support team liaises with both tutors and learners to provide guidance, assessment feedback, and any other study support adequately and promptly. Once a learner raises a support request through the support desk portal (Be it for guidance, assessment feedback or any additional assistance), one of the support team members assign the relevant to request to an allocated tutor. As soon as the support receives a response from the allocated tutor, it will be made available to the learner in the portal. The support desk system is in place to assist the learners adequately and streamline all the support processes efficiently. Quality learning materials made by industry experts is a significant competitive edge of the School of Business & Technology London. Quality learning materials comprised of structured lecture notes, study guides, practical applications which includes real-world examples, and case studies that will enable you to apply your knowledge. Learning materials are provided in one of the three formats, such as PDF, PowerPoint, or Interactive Text Content on the learning portal. How does the Online Learning work at SBTL? We at SBTL follow a unique approach which differentiates us from other institutions. Indeed, we have taken distance education to a new phase where the support level is incredibly high.Now a days, convenience, flexibility and user-friendliness outweigh demands. Today, the transition from traditional classroom-based learning to online platforms is a significant result of these specifications. In this context, a crucial role played by online learning by leveraging the opportunities for convenience and easier access. It benefits the people who want to enhance their career, life and education in parallel streams. SBTL's simplified online learning facilitates an individual to progress towards the accomplishment of higher career growth without stress and dilemmas. How will you study online? With the School of Business & Technology London, you can study wherever you are. You finish your program with the utmost flexibility. You will be provided with comprehensive tutor support online through SBTL Support Desk portal. How will I get tutor support online? School of Business & Technology London occupies a centralised tutor support desk portal, through which our support team liaise with both tutors and learners to provide guidance, assessment feedback, and any other study support adequately and promptly. Once a learner raises a support request through the support desk portal (Be it for guidance, assessment feedback or any additional assistance), one of the support team members assign the relevant to request to an allocated tutor. As soon as the support receive a response from the allocated tutor, it will be made available to the learner in the portal. The support desk system is in place to assist the learners adequately and to streamline all the support process efficiently. Learners should expect to receive a response on queries like guidance and assistance within 1 - 2 working days. However, if the support request is for assessment feedback, learners will receive the reply with feedback as per the time frame outlined in the Assessment Feedback Policy.