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Special Executive Masters Programme (S.E.M.P) This programme is geared at enhancing professionals' careers. The SEMP is an encapsulated Senior Management Programmes are short certificate modules designed for anyone who would benefit from more in-depth business knowledge delivered in a short and intensive programme What makes us different? We are a world class business school located in the heart of London, Dubai, Islamabad and Lagos. We are one of the fastest growing British business schools with a stylish blended learning model that is both online and on campus. Learn more about the programme Special Executive Master's Programme in Business Enterprise Software Course Overview The MSBM Special Executive Masters Programmes (SEMP) allows you to update your skills, develop new skills, and explore and develop interests in a wide range of topics. These courses can be taken as personal or professional development and may enhance your employability. Business Enterprise Software is a professional area of practice that assists enterprises in designing solutions to achieve their current and future business objectives. While enterprise software has most often been applied to complex technology environments with high technology investments, the practice is relevant for all types and sizes of enterprises. All enterprises have business goals and objectives, and all have resources that must be aligned with those goals in an effective and efficient way. Enterprise software is a critical first step in achieving those goals. One of the most important lessons from enterprise software is the importance of design and engineering before implementation.  Business Enterprise Software is a critical area today given the increasing complexity of our environment and the need for greater agility. The virtualization of work, the multinational nature of work, the increasingly semantic and personalized nature of applications, the richness of technology, the increasingly networked nature of the business, a shift from simple projects to complex projects — all speak to the need for Business Enterprise Software. Course Details Mode of Study Using Web-based technology, this program provides self-paced, individualized instruction that can be taken anywhere and anytime an individual has access to a computer and the Internet. This Programme is suitable for successful professionals or specialists in the private, public, or voluntary sectors who have new management responsibilities and need to quickly expand their management knowledge. This Programme serves as a refresher course for those who have had their Masters a long time ago and need quick reminders and professional/ academic updates while it serves as a primer for those very experienced Professionals who never made time out for their masters yet they require the academic and practical relevance of this master’s experience. It is a short executive training that runs online for 3 months. Candidates will run 2 months of active lectures and series of assignments and 1 month for their dissertation. Upon successful completion of the Programme, candidates will be awarded a Continuing Professional Development (CPD) certificate in the specific Programme they have completed. What is a CPD Course? Continuing Professional Development (CPD) is the means by which professionals maintain and enhance their knowledge and skills. The world is constantly moving at a very fast pace so undertaking CPD is essential to support a professional in his/her current role as well as helping them with career progression. CPD is all about upgrading knowledge, skills, and capabilities to remain effective and compliant. A CPD course is an investment that you make in yourself. It’s a way of planning your development that links learning directly to practice. CPD can help you keep your skills and knowledge up to date and prepare you for greater responsibilities. It can boost your confidence, strengthen your professional credibility, and help you become more creative in tackling new challenges. Is the SEMP Business Enterprise Software Programme, right for me? Many organizations are embracing the use of business software to support their business priorities and objectives, and are implementing initiatives and programs to deploy business analytics across the enterprise. For these initiatives to succeed, organizations need to understand the key drivers that will facilitate the promotion and deployment of business analytics across the enterprise. The SEMP BES online program will provide an overview of the key organizational drivers and dimensions and will explore how business software should be aligned to support the organization's priorities. This online Programme will also discuss the role and function of enterprise Business software centers of excellence and their types and mandates. The SEMP BES will provide a guideline for assessing your organization's maturity, and for establishing a roadmap for an Enterprise Business Software Center of Excellence at your organization.   Why SEMP Business Enterprise Software?  This non-credit-bearing course provides an excellent introduction to the world of business process and systems consulting, implementation, and management. It is particularly relevant both for experienced consultants that wish to gain a broader knowledge of Business enterprise and those wishing to enter business for the first time. The course enables you to rapidly gain knowledge about how modern management information systems are structured, how they are managed and the issues in integrating them to support effective business decision making. You will take away a deep understanding of how to integrate business systems and the processes underlying them. You will gain not only knowledge of specific aspects of business enterprise, but also gain an appreciation for how a large enterprise attempts to pull together different business processes through a coherent enterprise system, and the challenges facing the elite consulting companies in implementing such systems.   Who should enrol in this online Certificate Program? This online certificate program in Information System benefits professionals at all levels who want to contribute to their organization’s performance. Here are some of the people who will benefit from the online Programme: Cross-functional teams from within an organization can take the program, as that accelerates the impact and engenders a common language and understanding in the organization I.T Managers Business owners in the I.T Industry IT Trainers Accreditation The content of this course has been independently certified as conforming to universally accepted Continuous Professional Development (CPD) guidelines. Entry Requirements There are no strict entry requirements for this course. Work experience will be added advantage to understanding the content of the course. Workshops This is a self-study programme with unlimited tutor support. You will never be more than a message or phone call away from our tutors.

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PgMP® Exam Prep: In-House Training This course is designed and developed by PgMP® certified consultants and instructors. Its aim is to prepare professionals who are familiar with the principles of program management for the Program Management Professional (PgMP)® Examination. The course is based on PMI's The Standard for Program Management, A Guide to the Project Management Body of Knowledge (PMBOK® Guide), and PMI's Program Management Professional (PgMP)® Examination Content Outline (current versions). Through this learning experience, you will explore: Program management from a PMI standard perspective, including the interdependencies between the five performance domains, the three program phases, and the ten supporting activities in this new and improved program management standard The difference between the five performance domains in the new program management standard and the five practice domains in the examination content outline The role and competencies of the program manager The difference between project managers and program managers - and their relationship in a program environment The difference between program managers and portfolio managers - and their relationship in a program environment How program managers align and manage benefits The best ways to engage and involve program stakeholder groups How to establish governance across the program life cycle What You Will Learn At the end of this course, you will be able to: Differentiate between the practice domains in the PMI PgMP® Examination Content Outline and the performance domains in The Standard for Program Management - Fourth Edition Name and describe the three phases in the program management life-cycle phases Describe the mapping of the life-cycle phases with the supporting program activities Identify the key outputs of the supporting program activities Articulate the interrelationships between the program management supporting processes and the mapping of processes to Knowledge Areas and Process Groups in the PMBOK® Guide - Sixth Edition Apply program management knowledge to answer foundation and scenario-based questions Summarize the process and eligibility criteria for earning the PgMP® credential Getting Started Introductions Course structure Course goals and objectives Foundation Concepts Programs, projects, and portfolio definitions differences, and how they relate The definition of a component and how it relates to a program Representative program management life cycle Role of the program manager and the program office The difference between the program management practice and performance domains Program Register and Knowledge Asset Management Program registers, and how they are used to manage knowledge assets Knowledge asset management, beginning with the data, information, knowledge, and wisdom (DIKW) Model Knowledge assets and relationship to the performance domains The program manager as a knowledge asset manager Types of Programs Perspectives on programs to establish the 'right' perspective Categories of programs based on the program standard Scenario-based questions Program and Organization Strategy Alignment An overview of the Program Strategy Alignment performance domain Exploration of the elements of strategic alignment, i.e., the business case, program charter, and program roadmap Exploration of organization maturity and strategic alignment Scenario-based questions that reference both the Program Strategy Alignment performance domain and the Strategic Program Management practice domain Program Benefits An overview of the Program Benefits Management performance domain Exploration of each benefits management interaction with the representative program management life cycle: Benefits IdentificationBenefits Analysis and PlanningBenefits DeliveryBenefits TransitionBenefits SustainmentScenario-based questions that reference both the Program BenefitsManagement performance domain and the Benefits Management practice domain Program Stakeholder Engagement An overview of the Program Stakeholder Engagement performance domain Exploration of each stakeholder engagement performance domain activity: Program Stakeholder IdentificationProgram Stakeholder AnalysisProgram Stakeholder Engagement PlanningProgram Stakeholder EngagementProgram Stakeholder CommunicationsScenario-based questions that reference both the Program StakeholderEngagement performance domain and the Stakeholder Management practice domain Program Governance An overview of the Program Governance performance domain Exploration of each program governance performance domain activity: Program governance practicesProgram governance roles and responsibilitiesProgram governance design and implementationGovernance relationship within programsScenario-based questions that reference both the Program Governance performance domain and the Governance practice domain Program Life Cycle Management An overview of the Program Life Cycle Management performance domain Exploration of the three phases in the representative program life cycle: Program DefinitionProgram DeliveryProgram ClosureExploration of the interaction between program activities and integration managementScenario-based questions that reference both the Program Life CycleManagement performance domain and the Program Life Cycle practice domain Program Management Supporting Activities - Part 1 An overview of the program management supporting activities Exploration of 5 of 10 supporting activities: Program change managementProgram communications managementProgram financial managementProgram information managementProgram procurement managementScenario-based question(s) presented after each supporting activity Program Management Supporting Activities - Part 2 Exploration of the remaining 6 of 10 supporting activities: Program quality managementProgram resource managementProgram risk managementProgram schedule managementProgram scope managementScenario-based question(s) presented after each supporting activity Program Management Professional (PgMP®) Examination Application process and timeline General and special eligibility criteria International Institute's Online Learning Tool - access to sample examination questions Program Management Professional (PgMP®) Examination breakdown of domains and subdomains Terms and conditions of the exam PgMP® Professional Code of Conduct

PgMP® Exam Prep This course is designed and developed by PgMP® certified consultants and instructors. Its aim is to prepare professionals who are familiar with the principles of program management for the Program Management Professional (PgMP)® Examination. The course is based on PMI's The Standard for Program Management, A Guide to the Project Management Body of Knowledge (PMBOK® Guide), and PMI's Program Management Professional (PgMP)® Examination Content Outline (current versions). Through this learning experience, you will explore: Program management from a PMI standard perspective, including the interdependencies between the five performance domains, the three program phases, and the ten supporting activities in this new and improved program management standard The difference between the five performance domains in the new program management standard and the five practice domains in the examination content outline The role and competencies of the program manager The difference between project managers and program managers - and their relationship in a program environment The difference between program managers and portfolio managers - and their relationship in a program environment How program managers align and manage benefits The best ways to engage and involve program stakeholder groups How to establish governance across the program life cycle What You Will Learn At the end of this course, you will be able to: Differentiate between the practice domains in the PMI PgMP® Examination Content Outline and the performance domains in The Standard for Program Management - Fourth Edition Name and describe the three phases in the program management life-cycle phases Describe the mapping of the life-cycle phases with the supporting program activities Identify the key outputs of the supporting program activities Articulate the interrelationships between the program management supporting processes and the mapping of processes to Knowledge Areas and Process Groups in the PMBOK® Guide - Sixth Edition Apply program management knowledge to answer foundation and scenario-based questions Summarize the process and eligibility criteria for earning the PgMP® credential Getting Started Introductions Course structure Course goals and objectives Foundation Concepts Programs, projects, and portfolio definitions differences, and how they relate The definition of a component and how it relates to a program Representative program management life cycle Role of the program manager and the program office The difference between the program management practice and performance domains Program Register and Knowledge Asset Management Program registers, and how they are used to manage knowledge assets Knowledge asset management, beginning with the data, information, knowledge, and wisdom (DIKW) Model Knowledge assets and relationship to the performance domains The program manager as a knowledge asset manager Types of Programs Perspectives on programs to establish the 'right' perspective Categories of programs based on the program standard Scenario-based questions Program and Organization Strategy Alignment An overview of the Program Strategy Alignment performance domain Exploration of the elements of strategic alignment, i.e., the business case, program charter, and program roadmap Exploration of organization maturity and strategic alignment Scenario-based questions that reference both the Program Strategy Alignment performance domain and the Strategic Program Management practice domain Program Benefits An overview of the Program Benefits Management performance domain Exploration of each benefits management interaction with the representative program management life cycle: Benefits IdentificationBenefits Analysis and PlanningBenefits DeliveryBenefits TransitionBenefits SustainmentScenario-based questions that reference both the Program BenefitsManagement performance domain and the Benefits Management practice domain Program Stakeholder Engagement An overview of the Program Stakeholder Engagement performance domain Exploration of each stakeholder engagement performance domain activity: Program Stakeholder IdentificationProgram Stakeholder AnalysisProgram Stakeholder Engagement PlanningProgram Stakeholder EngagementProgram Stakeholder CommunicationsScenario-based questions that reference both the Program StakeholderEngagement performance domain and the Stakeholder Management practice domain Program Governance An overview of the Program Governance performance domain Exploration of each program governance performance domain activity: Program governance practicesProgram governance roles and responsibilitiesProgram governance design and implementationGovernance relationship within programsScenario-based questions that reference both the Program Governance performance domain and the Governance practice domain Program Life Cycle Management An overview of the Program Life Cycle Management performance domain Exploration of the three phases in the representative program life cycle: Program DefinitionProgram DeliveryProgram ClosureExploration of the interaction between program activities and integration managementScenario-based questions that reference both the Program Life CycleManagement performance domain and the Program Life Cycle practice domain Program Management Supporting Activities - Part 1 An overview of the program management supporting activities Exploration of 5 of 10 supporting activities: Program change managementProgram communications managementProgram financial managementProgram information managementProgram procurement managementScenario-based question(s) presented after each supporting activity Program Management Supporting Activities - Part 2 Exploration of the remaining 6 of 10 supporting activities: Program quality managementProgram resource managementProgram risk managementProgram schedule managementProgram scope managementScenario-based question(s) presented after each supporting activity Program Management Professional (PgMP®) Examination Application process and timeline General and special eligibility criteria International Institute's Online Learning Tool - access to sample examination questions Program Management Professional (PgMP®) Examination breakdown of domains and subdomains Terms and conditions of the exam PgMP® Professional Code of Conduct

This course bundle is made up of three separate certification courses: 1. PRINCE2® Foundation; 2. PRINCE2® Practitioner; 3. IASSC Lean Six Sigma Black Belt. The PRINCE2® Foundation And Practitioner course includes the official certification exams. By passing the Foundation and Practitioner exams, you will be an officially certified PRINCE2® Practitioner. The IASSC Lean Six Sigma Black Belt course includes the official IASSC Six Sigma Black Belt exam. By passing this exam, you will be officially certified by the IASSC as a Six Sigma Black Belt. You have 14 months to complete all of the courses in this bundle and take the exams. Read below to find out more about the courses contained within this bundle.

Course Information In today's evolving landscape, pharmacovigilance (PV) systems face ongoing challenges due to global, national, and company-specific events. This course focuses on developing personnel equipped to navigate these complexities and improve the safe use of medicinal products. We emphasise continuous global thinking, communication, and strategic planning, ensuring adaptability across various levels. The course explores maintaining PV system functionality while adhering to regulatory requirements. Participants will apply European regulatory standards to enhance and sustain PV system effectiveness, contributing to improvement initiatives and ensuring operational integrity. The course covers PV system intricacies, regulatory compliance, and a 'systems approach' for auditors, quality assurance personnel, and PV practitioners. Through presentations and workshops, attendees gain insights into implementing and maintaining an effective PV system. Who should attend? Auditors Pharmacovigilance Quality System Managers Pharmacovigilance scientists The QPPV. Course benefits Throughout the course delegates will explore application of the legal requirements for the PV system and quality system and how to assure these systems. They will demonstrate their ability to contribute to: A systematic investigation of the pharmacovigilance system and its quality system Examination of how the pharmacovigilance system and quality system interact to achieve compliance. The risk-based approach to auditing the PV system and quality system The maintenance of 'inspection readiness' Explore how to investigate the complex PV system Discussions about how to monitor and maintain the PV system and assure compliance. Course Objectives Clarify what has to be done: Explore application of the legal requirements. Explore how to do what has to be done: Adopt a systemic approach to systematically investigate or implement and maintain the PV system and quality system Examine how a compliant PV system and a compliant quality system interact to achieve compliance with regulatory requirements for PV Explore how to investigate the complexity of the PV system. Discus how to identify what is missing or what needs to be improved: Discuss how to monitor and maintain the PV system and assure compliance. This course will assist delegates with: An understanding of key system principles, A practical approach to implementing, maintaining and monitoring the PV system and its quality system A procedure to share expertise to increase efficiency and confidence. This course is structured to encourage delegates to: Discuss and develop ideas - Share knowledge and experiences - Solve specific problems.  By the end of the course delegates will be able to: Understand better the pharmacovigilance system, its quality system and how the components interact to achieve the objectives of pharmacovigilance Investigate, and analyse the pharmacovigilance system and to identify what is missing and what needs to be improved. Tutors Tutors will be comprised of (click the photos for biographies): Jana Hyankova Head of PV Department, IVIGEE Services a.s. Programme Please note timings may be subject to alteration. Day 1 08:30 Welcome, registration, course objectives and introduction to work groups Housekeeping notices, meet other delegates, explore how to work in your work group, course objectives. Clarify the definition and objectives of Pharmacovigilance. 09:30 The Regulatory Framework for Pharmacovigilance Identify the relevant regulations and directives. Explore GVP guidance, structure of the modules and standard format of each module. 10:00 The Pharmacovigilance System Exploration of how to organise what has to be done, communications. Exploration of the structures and processes for pharmacovigilance. 10:30 Break 11:00 Workshop 1 and Feedback Exploring an organisational model of the pharmaceutical company- cooperation between PV and other stakeholders. 12:00 The Quality System for pharmacovigilance Exploration of the structures, processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently. 13:00 Lunch 14:00 Workshop 2 and Feedback The quality system puzzle. Explore the organisation of the PV quality system and how it interacts with the PV system. 14:30 The Quality System for pharmacovigilance Exploration of the structures processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently. 15:00 Description of PV System 15:30 Break 15:30 Workshop 3 and Feedback The quality system puzzle Explore the organisation of the PV quality system and how it interacts with the PV system. 16:00 The Pharmacovigilance Safety Master File Construction of the Pharmacovigilance System Master File and its purpose. 17:00 Workshop 3 and Feedback Description of PV System. 18:00 End of Day Day 2 08:30 Drug Safety in the Clinical Trial Environment - Part 1 Information flow and responsibilities of the sponsor. 09:30 Workshop 4 and Feedback Drug Safety in the Clinical Trial environment: Information flow and responsibilities of the sponsor. 10:30 Break 11:00 Drug Safety in the Clinical Trial Environment - Part 2 Information flow and responsibilities of the sponsor. 12:00 Lunch 13:00 Workshop 5 and Feedback Drug Safety in the clinical trial environment: Information flow and responsibilities of the sponsor. 13:30 Processing of Safety Data Exploration of safety data processing, verification, validation, follow up, formatting and collation, reporting requirements, quality and data management. 15:00 Break 15:30 EudraVigilance Exploration of how EudraVigilance supports the PV system. 16:15 Signal Detection and Evaluation/Risk Benefit Assessment: Pharmacovigilance Risk Assessment Committee (PRAC): What is a signal? What are the regulatory requirements? How is signal detection and evaluation conducted? Qualitative and quantitative methods of signal detection. Risk benefit assessment. 17:00 Risk Management Plans A cornerstone of Pharmacovigilance safety communications, direct healthcare professional communication 18:00 End of Day Day 3 08:30 The Pharmacovigilance Risk Assessment Committee (PRAC) Exploration of how good practice is achieved. Composition, role and responsibilities. Examples of referrals. 09:15 Development Safety Update Reports (DSURs): Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 10:00 Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 10:30 Break 11:00 Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 12:00 Workshop 6 and Feedback To explore the compilation and submission of the PSUR. 13:00 Lunch 13:30 Role of the QPPV Exploration of the legal responsibilities of the QPPV and the MAH. 14:30 Break 15:00 Workshop 7 and Feedback To explore the challenges faced by the QPPV. 15:30 End of course Extra Information Face-to-Face Course Course material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device< Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking You will need a stable internet connection, a microphone and a webcam. CPD Points 23 Points   Development Level Develop

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