Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data. The International Council for Harmonisation’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.
To conduct a clinical trial in the European Economic Area under the Clinical Trials Directive the sponsor must apply for authorisation from the national competent authority (i.e. medicines regulator), and favourable opinion must be obtained from a research ethics committee, in each member state in which the trial is to take place. This module sets out the requirements for successful compilation, submission and maintenance of the applications.
An Investigational New Drug Application (IND) is a submission to the US Food and Drug Administration (FDA) for permission to conduct a clinical trial of a medicinal product. This module describes regulatory requirements that sponsors or sponsor-investigators must meet for successful compilation, filing and maintenance of INDs. The IND and its role are defined, and the contexts in which it is required are specified.
Drug safety monitoring and risk management are vitally important for medicinal product developers, licence holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety / pharmacovigilance and that all staff are aware of the basic requirements. This course will provide them with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.
FREE PDF & Hard Copy Certificate| PDF Transcripts| FREE Student ID| Assessment| Lifetime Access| Enrolment Letter
This 3D animated experience will allow you to assume the role of a project manager as you carry out project-related activities and exercises in a simulated project environment. About this course £199.00 55 lessons Course curriculum IntroductionIntroduction Scenario 11.0 An Overview of the Project1.1 Activity Information1.2 Activity Questions1.3 Scenario Review Scenario 22.0 Getting a Project Started2.1 Activity Information2.2 Activity Questions2.3 Scenario Review Scenario 33.0 Activity and Stage Planning3.1 Activity Information3.2 Activity Questions3.3 Scenario Review Scenario 44.0 Planning for Project Risk4.1 Activity Information4.2 Activity Questions4.3 Scenario Review Scenario 55.0 Estimating the Project Cost5.1 Activity Information5.2 Activity Questions5.3 Scenario Review
Feeling Stuck in Your Career? The Mechanical Engineering with Mechatronics Engineering for Mechanic - 30 in 1 Courses Bundle is Your Skill-Building Solution. This exceptional collection of 30 premium courses is designed to encourage growth and improve your career opportunities. Suited to meet different interests and goals, the Mechanical Engineering bundle provides an engaging learning experience, helping you learn skills across various disciplines. With the Mechanical Engineering with Mechatronics Engineering for MechanicBundle, you'll have a personalised journey that aligns with your career goals and interests. This comprehensive package helps you confidently tackle new challenges, whether entering a new field or enhancing your existing knowledge. The Mechanical Engineering bundle is your gateway to expanding your career options, increasing job demand, and enhancing your skill set. By enrolling in this bundle, you'll receive complimentary PDF certificates for all courses, adding value to your resume at no extra cost. Develop key skills and achieve important progress in your career and personal development. Start your journey today and experience the transformative impact of the Mechanical Engineering bundle on your job life and career growth! This Mechanical Engineering with Mechatronics Engineering for MechanicBundle Comprises the Following CPD Accredited Courses: Course 01: Mechanical Engineering Course 02: Engineering Mechanics Course for Beginners Course 03: Crack Your Mechanical Engineer Interview Course 04: Automotive Engineering: Onboard Diagnostics Course 05: Automotive Design Course 06: Hybrid Vehicle Expert Training Course 07: Engine Lubrication Systems Online Course Course 08: Rotating Machines Course 09: Electric Circuits for Electrical Engineering Course 10: Electrical Machines for Electrical Engineering Course 11: Electronic & Electrical Devices Maintenance & Troubleshooting Course 12: Digital Electric Circuits & Intelligent Electrical Devices Course 13: MATLAB Simulink for Electrical Power Engineering Course 14: Power Electronics for Electrical Engineering Course 15: Energy Engineer Course Course 16: Energy Saving in Electric Motors Course 17: Electric Vehicle Battery Management System Course 18: A complete course on Turbocharging Course 19: Heating Ventilation and AirConditioning (HVAC) Technician Course 20: Python Intermediate Training Course 21: Spatial Data Visualisation and Machine Learning in Python Course 22: Data Center Training Essentials: Mechanical & Cooling Course 23: Career Development Plan Fundamentals Course 24: CV Writing and Job Searching Course 25: Learn to Level Up Your Leadership Course 26: Networking Skills for Personal Success Course 27: Ace Your Presentations: Public Speaking Masterclass Course 28: Learn to Make a Fresh Start in Your Life Course 29: Motivation - Motivating Yourself & Others Course 30: Excel: Top 50 Microsoft Excel Formulas in 50 Minutes! What will make you stand out? Upon completion of this online Mechanical Engineering with Mechatronics Engineering for MechanicBundle, you will gain the following: CPD QS Accredited Proficiency with this Mechanical Engineering bundle After successfully completing the Mechanical Engineering bundle, you will receive a FREE PDF Certificate from REED as evidence of your newly acquired abilities. Lifetime access to the whole collection of learning materials of this Mechanical Engineering bundle The online test with immediate results You can study and complete the Mechanical Engineering bundle at your own pace. Study for the Mechanical Engineering bundle using any internet-connected device, such as a computer, tablet, or mobile device. The Mechanical Engineering with Mechatronics Engineering for Mechanicbundle is a premier learning resource, with each course module holding respected CPD accreditation, symbolising exceptional quality. The content is packed with knowledge and is regularly updated to ensure it remains relevant. This bundle offers not just education but a constantly improving learning experience designed to enrich both your personal and professional development. Advance the future of learning with the Mechanical Engineering bundle, a comprehensive complete collection of 30 courses. Each course in the Mechanical Engineering bundle has been handpicked by our experts to provide a broad range of learning opportunities. Together, these modules form an important and well-rounded learning experience. Our mission is to deliver high-quality, accessible education for everyone. Whether you are starting your career, switching industries, or enhancing your professional skills, the Mechanical Engineering bundle offers the flexibility and convenience to learn at your own pace. Make the Mechanical Engineering package your trusted partner in your lifelong learning journey. CPD 300 CPD hours / points Accredited by CPD Quality Standards Who is this course for? The Mechanical Engineering with Mechatronics Engineering for Mechanicbundle is perfect for: Expand your knowledge and skillset for a fulfilling career with the Mechanical Engineering bundle. Become a more valuable professional by earning CPD certification and mastering in-demand skills with the Mechanical Engineering bundle. Discover your passion or explore new career options with the diverse learning opportunities in the Mechanical Engineering bundle. Learn on your schedule, in the comfort of your home - the Mechanical Engineering bundle offers ultimate flexibility for busy individuals. Requirements You are warmly invited to register for this bundle. Please be aware that no formal entry requirements or qualifications are necessary. This Mechanical Engineering with Mechatronics Engineering for Mechanic bundle curriculum has been crafted to be open to everyone, regardless of previous experience or educational attainment. Career path Gain a wide range of skills across various fields, improve your problem-solving capabilities, and keep current with industry trends. Perfect for those aiming for career advancement, exploring a new professional direction, or pursuing personal growth. Begin your journey with the Mechanical Engineering with Mechatronics Engineering for Mechanicbundle. Certificates CPD Certificates Digital certificate - Included
Advanced Professional Certificate Courses These are short online certificate courses of a more advanced nature designed to help you develop professionally and achieve your career goals, while you earn a professional certificate which qualifies you for the appropriate continuous professional development (CPD). Advanced Professional Certificate in Strategic Management Advanced Professional Certificate in Strategic Management Aims to enable the learner to understand the fundamental concepts of strategic management and the role of strategy in a business context so that the learner is able to Analyze, Plan and implement strategies for achieving the business strategic goals successfully. The learner will be able to understand the fundamental purpose a business stands for and will be able to learn and develop Vision, Mission, Organization Objective and Goals and formulate strategies. The course aims to enable the learner to understand the business environment, players and dynamics that shape the environment, and different strategies to achieve a competitive advantage and compete over the long term by presenting the business in a unique proposition using different tools and methods such as the SWOT Analysis, BCG Matrix Portfolio Analysis, Stakeholder Analysis, Five Forces Framework, 7 S’s Framework for Analysis, Value Chain Analysis. Learning Outcomes After the successful completion of the certificate, the student will be able to: Explain what is meant by strategy and strategic management Appreciate the importance of strategic management Strategy formulation, Types of Strategies, Deliberate and emergent strategies Understanding the competitive Environment, environmental analysis, 7 S’s Framework Examine SWOT and BCG matrix as tools and models available to analyze the environment Examine Product Market Matrix, Life Cycle Analysis, Porter’s Five Force Framework and Value Chain Analysis as tools and models available to analyze the environment Who is a stakeholder? Stakeholder analysis and relevant strategies Explain ‘Mission’ and ‘Vision’ and provide some examples of mission statements What is core competence? difference between core and general competence Examine how an existing core competence can be evaluated Explain what is meant by competition and competitive advantage Why is it important for a firm to have some form of competitive advantage? Strategic factors and competitive forces Strategic Alliance and Cooperative Strategies Define strategic planning, stages in the strategic planning cycle Examine the various approaches to strategy evaluation Examine the process of effective strategy implementation Highlight the relationship between the strategy development process and implementation Accreditation All MSBM courses are accredited by the relevant partners and awarding bodies. Please refer to MSBM accreditation in about us for more details. Entry Requirements There are no strict entry requirements for this course. Work experience will be added advantage to understanding the content of the course. The certificate is designed to enhance the knowledge of the learner in the field. This certificate is for everyone eager to know more and gets updated on current ideas in their respective field. We recommend this certificate for the following audience. CEO, Director, Manager, Supervisor Business Professional Entrepreneur Business Owner Strategy Manager Strategy Planner Strategic Manger Management Roles
Advanced Professional Certificate Courses These are short online certificate courses of a more advanced nature designed to help you develop professionally and achieve your career goals, while you earn a professional certificate which qualifies you for the appropriate continuous professional development (CPD). Advanced Professional Certificate in Strategic Financial Management Advanced Professional Certificate in Strategic Financial Management aims to enable the learner to strategically manage the finances of an organization by learning key concepts and skills in financial statement analysis, Identifying and evaluating sources of finance, cost analysis and control, analysis and preparation of financial budgets while using the relevant accounting practices for the strategic success of the organization. The learner will be able to interpret, analyze and develop financial statements, gather useful financial information and control the costs of business operations with a detailed understanding of different types of financial statements, their structure, purpose and underlying concept and the latest techniques and methods employed in Cash flow controls. The learner will also be able to evaluate and appraise different investment options. Learning Outcomes After the successful completion of the certificate, the student will be able to learn: The introduction, objectives and features of cost accounting. Difference between cost accounting and financial accounting. Various tools of cost accounting. Understanding the concept and Types of Costing Systems The various strategies of pricing policy. Financial performance and financial performance measures and analysis. Understanding the nature and utility of different financial ratios. Introduction to the Budgeting. To learn about vital roles in budget preparation. Concept, types and different approches to Budgeting. Study the various classification of sources of funds. Different concepts, motives and analysis of investment. The concept of working capital management. Accreditation All MSBM courses are accredited by the relevant partners and awarding bodies. Please refer to MSBM accreditation in about us for more details. Entry Requirements There are no strict entry requirements for this course. Work experience will be added advantage to understanding the content of the course. The certificate is designed to enhance the knowledge of the learner in the field. This certificate is for everyone eager to know more and gets updated on current ideas in their respective field. We recommend this certificate for the following audience. CEO, CFO, Director, Manager, Supervisor Finance Manager Investment Manager General Manager Accountants Line and functional Managers
Feeling Stuck in Your Career? The Mechanical Engineering, Automotive Design & Automotive Engineering Bundle is Your Skill-Building Solution. This exceptional collection of 30 premium courses is designed to encourage growth and improve your career opportunities. Suited to meet different interests and goals, the Mechanical Engineering bundle provides an engaging learning experience, helping you learn skills across various disciplines. With the Mechanical Engineering, Automotive Design & Automotive Engineering Bundle, you'll have a personalised journey that aligns with your career goals and interests. This comprehensive package helps you confidently tackle new challenges, whether entering a new field or enhancing your existing knowledge. The Mechanical Engineering bundle is your gateway to expanding your career options, increasing job demand, and enhancing your skill set. By enrolling in this bundle, you'll receive complimentary PDF certificates for all courses, adding value to your resume at no extra cost. Develop key skills and achieve important progress in your career and personal development. Start your journey today and experience the transformative impact of the Mechanical Engineering bundle on your job life and career growth! This Mechanical Engineering, Automotive Design & Automotive Engineering Bundle Comprises the Following CPD Accredited Courses: Course 01: Mechanical Engineering Course 02: Engineering Mechanics Course for Beginners Course 03: Automotive Engineering: Onboard Diagnostics Course 04: Diploma in Supercharger Automobile Engineering Course 05: Automotive Design Course 06: Crack Your Mechanical Engineer Interview Course 07: Energy Engineer Course Course 08: Hybrid Vehicle Expert Training Course 09: Large Goods Vehicle (LGV) Course 10: Engine Lubrication Systems Online Course Course 11: Car Mechanic Interactive Online Training Course 12: Bicycle Maintenance Course Course 13: Motorbike Maintenance Course Course 14: Certificate Course In Two Wheeler Servicing Course 15: Electric Vehicle Battery Management System Course 16: Power Electronics for Electrical Engineering Course 17: A complete course on Turbocharging Course 18: Energy Saving in Electric Motors Course 19: Engineering Management Course 20: Heating Ventilation and AirConditioning (HVAC) Technician Course 21: MET Technician Course 22: Workshop Technology: Machine Shop Theory Course 23: Workplace First Aid Online Training Course Course 24: CV Writing and Job Searching Course 25: Learn to Level Up Your Leadership Course 26: Networking Skills for Personal Success Course 27: Ace Your Presentations: Public Speaking Masterclass Course 28: Learn to Make a Fresh Start in Your Life Course 29: Motivation - Motivating Yourself & Others Course 30: Excel: Top 50 Microsoft Excel Formulas in 50 Minutes! What will make you stand out? Upon completion of this online Mechanical Engineering, Automotive Design & Automotive Engineering Bundle, you will gain the following: CPD QS Accredited Proficiency with this Mechanical Engineering bundle After successfully completing the Mechanical Engineering bundle, you will receive a FREE PDF Certificate from REED as evidence of your newly acquired abilities. Lifetime access to the whole collection of learning materials of this Mechanical Engineering bundle The online test with immediate results You can study and complete the Mechanical Engineering bundle at your own pace. Study for the Mechanical Engineering bundle using any internet-connected device, such as a computer, tablet, or mobile device. TheMechanical Engineering, Automotive Design & Automotive Engineering bundle is a premier learning resource, with each course module holding respected CPD accreditation, symbolising exceptional quality. The content is packed with knowledge and is regularly updated to ensure it remains relevant. This bundle offers not just education but a constantly improving learning experience designed to enrich both your personal and professional development. Advance the future of learning with the Mechanical Engineering bundle, a comprehensive complete collection of 30 courses. Each course in the Mechanical Engineering bundle has been handpicked by our experts to provide a broad range of learning opportunities. Together, these modules form an important and well-rounded learning experience. Our mission is to deliver high-quality, accessible education for everyone. Whether you are starting your career, switching industries, or enhancing your professional skills, the Mechanical Engineering bundle offers the flexibility and convenience to learn at your own pace. Make the Mechanical Engineering package your trusted partner in your lifelong learning journey. CPD 300 CPD hours / points Accredited by CPD Quality Standards Who is this course for? The Mechanical Engineering, Automotive Design & Automotive Engineering the bundle is perfect for: Expand your knowledge and skillset for a fulfilling career with the Mechanical Engineering bundle. Become a more valuable professional by earning CPD certification and mastering in-demand skills with the Mechanical Engineering bundle. Discover your passion or explore new career options with the diverse learning opportunities in the Mechanical Engineering bundle. Learn on your schedule, in the comfort of your home - the Mechanical Engineering bundle offers ultimate flexibility for busy individuals. Requirements You are warmly invited to register for this bundle. Please be aware that no formal entry requirements or qualifications are necessary. This curriculum has been crafted to be open to everyone, regardless of previous experience or educational attainment. Career path Gain a wide range of skills across various fields, improve your problem-solving capabilities, and keep current with industry trends. Perfect for those aiming for career advancement, exploring a new professional direction, or pursuing personal growth. Begin your journey with the Mechanical Engineering, Automotive Design & Automotive Engineering bundle. Certificates CPD Certifices Digital certificate - Included