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This course will provide those who require it, the knowledge of how to use Face Masks correctly...

Overview Uplift Your Career & Skill Up to Your Dream Job - Learning Simplified From Home! Kickstart your career & boost your employability by helping you discover your skills, talents and interests with our special Make Business Plans: Forecasting and Budgeting Course. You'll create a pathway to your ideal job as this course is designed to uplift your career in the relevant industry. It provides professional training that employers are looking for in today's workplaces. The Make Business Plans: Forecasting and Budgeting Course is one of the most prestigious training offered at StudyHub and is highly valued by employers for good reason. This Make Business Plans: Forecasting and Budgeting Course has been designed by industry experts to provide our learners with the best learning experience possible to increase their understanding of their chosen field. This Make Business Plans: Forecasting and Budgeting Course, like every one of Study Hub's courses, is meticulously developed and well researched. Every one of the topics is divided into elementary modules, allowing our students to grasp each lesson quickly. At StudyHub, we don't just offer courses; we also provide a valuable teaching process. When you buy a course from StudyHub, you get unlimited Lifetime access with 24/7 dedicated tutor support. Why buy this Make Business Plans: Forecasting and Budgeting? Unlimited access to the course for forever Digital Certificate, Transcript, student ID all included in the price Absolutely no hidden fees Directly receive CPD accredited qualifications after course completion Receive one to one assistance on every weekday from professionals Immediately receive the PDF certificate after passing Receive the original copies of your certificate and transcript on the next working day Easily learn the skills and knowledge from the comfort of your home Certification After studying the course materials of the Make Business Plans: Forecasting and Budgeting there will be a written assignment test which you can take either during or at the end of the course. After successfully passing the test you will be able to claim the pdf certificate for £5.99. Original Hard Copy certificates need to be ordered at an additional cost of £9.60. Who is this course for? This Make Business Plans: Forecasting and Budgeting course is ideal for Students Recent graduates Job Seekers Anyone interested in this topic People already working in the relevant fields and want to polish their knowledge and skill. Prerequisites This Make Business Plans: Forecasting and Budgeting does not require you to have any prior qualifications or experience. You can just enrol and start learning.This Make Business Plans: Forecasting and Budgeting was made by professionals and it is compatible with all PC's, Mac's, tablets and smartphones. You will be able to access the course from anywhere at any time as long as you have a good enough internet connection. Career path As this course comes with multiple courses included as bonus, you will be able to pursue multiple occupations. This Make Business Plans: Forecasting and Budgeting is a great way for you to gain multiple skills from the comfort of your home. Course Curriculum Introduction & Fundamentals Why Budget and Forecasts 00:11:00 Is budget planning a paper exercise 00:05:00 Operational and Financial Budget 00:07:00 Detail Budget Requirement Components - Revenue Budgets 00:05:00 Components - Cost Budget 00:11:00 Qualitative Aspects 00:05:00 Process of making budget Process of Budgeting - Logical Steps 00:09:00 Revenue Budget - What Information we need to make revenue budgets 00:08:00 The example we used in class to demonstrate a broad process in budget and planning 00:17:00 Cost Budget Process - Link from revenue and operational plan 00:05:00 Cost Budget Process - Other aspects 00:10:00

Overview Uplift Your Career & Skill Up to Your Dream Job - Learning Simplified From Home! Kickstart your career & boost your employability by helping you discover your skills, talents and interests with our special Set Menu Prices for Your Restaurant Using Data Course. You'll create a pathway to your ideal job as this course is designed to uplift your career in the relevant industry. It provides professional training that employers are looking for in today's workplaces. The Set Menu Prices for Your Restaurant Using Data Course is one of the most prestigious training offered at StudyHub and is highly valued by employers for good reason. This Set Menu Prices for Your Restaurant Using Data Course has been designed by industry experts to provide our learners with the best learning experience possible to increase their understanding of their chosen field. This Set Menu Prices for Your Restaurant Using Data Course, like every one of Study Hub's courses, is meticulously developed and well researched. Every one of the topics is divided into elementary modules, allowing our students to grasp each lesson quickly. At StudyHub, we don't just offer courses; we also provide a valuable teaching process. When you buy a course from StudyHub, you get unlimited Lifetime access with 24/7 dedicated tutor support. Why buy this Set Menu Prices for Your Restaurant Using Data? Unlimited access to the course for forever Digital Certificate, Transcript, student ID all included in the price Absolutely no hidden fees Directly receive CPD accredited qualifications after course completion Receive one to one assistance on every weekday from professionals Immediately receive the PDF certificate after passing Receive the original copies of your certificate and transcript on the next working day Easily learn the skills and knowledge from the comfort of your home Certification After studying the course materials of the Set Menu Prices for Your Restaurant Using Data there will be a written assignment test which you can take either during or at the end of the course. After successfully passing the test you will be able to claim the pdf certificate for £5.99. Original Hard Copy certificates need to be ordered at an additional cost of £9.60. Who is this course for? This Set Menu Prices for Your Restaurant Using Data course is ideal for Students Recent graduates Job Seekers Anyone interested in this topic People already working in the relevant fields and want to polish their knowledge and skill. Prerequisites This Set Menu Prices for Your Restaurant Using Data does not require you to have any prior qualifications or experience. You can just enrol and start learning.This Set Menu Prices for Your Restaurant Using Data was made by professionals and it is compatible with all PC's, Mac's, tablets and smartphones. You will be able to access the course from anywhere at any time as long as you have a good enough internet connection. Career path As this course comes with multiple courses included as bonus, you will be able to pursue multiple occupations. This Set Menu Prices for Your Restaurant Using Data is a great way for you to gain multiple skills from the comfort of your home. Course Curriculum Introduction & Fundamentals Introduction 00:01:00 Why we need to price the menu 00:05:00 Factors in determining prices 00:02:00 Determining Recipe Costs How to determine Cost of Menu - Fundamentals 00:07:00 Menu Costing Template Explained and key things to consider in costing 00:08:00 Excel Template Explained in more detailed part 1 00:04:00 Excel Template Explained in more detailed part 2 00:04:00 Profitability Concepts and Factoring Overheads in Pricing Gross Profit/ Net Profit and Overheads Concepts - Explained 00:04:00 Excel template to see if we need to increase prices 00:07:00 Excel Template to determine how much an average guest should be spending 00:07:00 Qualitative Factor in pricing of meny items 00:07:00

Software comes in a variety of guises - application software, firmware, middleware, system software. Increasingly, however, it doesn't necessarily present that way, especially as the boundaries between software, data and source code are becoming more and more blurred. And as software becomes more complex and more difficult to disentangle, so it becomes harder to manage and to value. But as it becomes more integral to every aspect of a business, so it is ever more important to keep on top of the technical, legal and commercial issues that arise, issues such as: To address these issues, organisations need a process for evaluating their current situation from all perspectives and for identifying the key actions they need to take to ensure holistic management of their software. This very practical programme will help set your organisation on the right path. Note: this is an indicative agenda, to be used as a starting point for a conversation between client and consultant, depending on the organisation's specific situation and requirements. This programme is designed to give you a deeper understanding of: The technical, legal and commercial risks associated with software development, procurement, use and commercial exploitation The most appropriate processes and responsibilities for managing those risks Note: this is an indicative agenda, to be used as a starting point for a conversation between client and consultant, depending on the organisation's specific situation and requirements. 1 Software business model What is the software business model? What options exist? Has the software business model been thoroughly reviewed to ensure its viability? This means fully understanding the market opportunity, the business environment and customer and end-user expectations. 2 Technology What are the technologies? How has the technology selection been validated considering the competitiveness, structure, and potential for future innovation? 3 UI and UX What is the UI and UX? How to best articulate this? Has the user interface and user experience been studied from both a subjective and objective view to give insight into customer behaviour? 4 Legal framework / commercial aspects Has the necessary legal framework or commercial aspects that may impact upon use or operation of the software been understood and risks identified and mitigated? 5 Software development What is the software development process? Are both the business management and development team's processes resilient in order to improve the company's capability and the maturity of the software? 6 Software quality What is quality? What are the metrics around software quality? What is the maturity level, based around a qualitative and quantitative assessment? 7 Intellectual property associated What IP should be considered when it comes to software? Does the company understand both the intellectual property risks and potential opportunities associated with this software? 8 Security What does software security mean in this context? How is it being addressed? 9 An holistic approach Review of roles and responsibilities to ensure appropriate management and protection

Getting Started The OTHM Level 7 Diploma in Strategic Marketing aims to equip learners with the skills and knowledge required for effective marketing and branding strategies that can help organisations maintain their competitive edge. The course provides an integrated approach that combines theoretical concepts in marketing, branding, consumer behaviour, and digital communication management with practical activities. Upon completing the course, learners will have developed their strategic marketing management, branding, and consumer behaviour skills, enabling them to better implement their organisation's strategy. Key Benefits This qualification will bring you many vital benefits, such as;   Demonstrate an understanding of the practical value of these frameworks in a range of strategic business situations. Create frameworks for understanding and analysing strategic marketing processes in diverse organisational types, encountering different and changing marketing environments. Develop practical research and analytical capabilities in the market/driven strategy context, particularly in formulating value propositions in provider/customer relationships.   Key Highlights Would you like to pursue a career in marketing? Then, the OTHM Level 7 Diploma in Strategic Marketing mentoring practice offered by the School of Business and Technology London is the right solution for you. Remember! The assessment for the qualification is done based on assignments only, and you do not need to worry about writing any exam. With the School of Business and Technology London, you can complete the qualification at your own pace, choosing online or blended learning from the comfort of your home. Learning and pathway materials and study guides developed by our OTHM-approved tutors will be available around the clock in our cutting-edge learning management system. Most importantly, at the School of Business and Technology London, we will provide comprehensive tutor support through our dedicated support desk. If you choose your course with blended learning, you will also enjoy live sessions with an assigned tutor, which you can book at your convenience.   Career Pathways The OTHM Level 7 Diploma in Strategic Marketing can open many career pathways including, but not limited to: Chief Marketing Officer; Est. Salary £97659p.a Marketing Manager; Est. Salary £ 53,277p.a Marketing Coordinator; Est. Salary £ 39,109p.a About Awarding Body OTHM is an established and recognised Awarding Organisation (Certification Body) launched in 2003. OTHM has already made a mark in the UK and global online education scenario by creating and maintaining a user-friendly and skill based learning environment. OTHM has both local and international recognition which aids OTHM graduates to enhance their employability skills as well as allowing them to join degree and/or Master top-up programmes. OTHM qualifications has assembled a reputation for maintaining significant skills in a wide range of job roles and industries which comprises Business Studies, Leadership, Tourism and Hospitality Management, Health and Social Care, Information Technology, Accounting and Finance, Logistics and Supply Chain Management. 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. UNIT1- Contemporary Issues and Principles of Marketing Reference No : Unit 1 - A/618/1614 Credit : 20 || TQT : 200 Hours This unit aims to teach learners to evaluate the impact of emerging marketing challenges and develop future marketing strategies using principles in different contexts. UNIT2- Consumer Behaviour & Market Communications Reference No : Unit 2 -F/618/1615 Credit : 20 || TQT : 200 Hours This unit aims to develop learners' theoretical and practical understanding of processes and factors that influence the consumer behaviour of individuals and organisations. UNIT3- Digital and Social Media Marketing Reference No : Unit 3 - J/618/1616 Credit : 20 || TQT : 200 Hours This module teaches learners a practical introduction to digital and social media technologies and how to use social media for branding and communication goals effectively. UNIT4- Contemporary Challenges and Strategic Marketing Reference No : Unit 4 - L/618/1617 Credit : 20 || TQT : 200 Hours The module provides a comprehensive examination of all the major components of marketing strategies marketing and their integration into organisations for continued success in a highly competitive market UNIT5- Strategic Brand Management Reference No : Unit 5 - R/618/1618 Credit : 20 || TQT : 200 Hours This unit aims to develop learner's understanding of the key principles that underpin managing brands and brand equity and how to do marketing from a branding perspective. UNIT6- Marketing Research Project Reference No : Unit 6 -Y/618/1619 Credit : 20 || TQT : 200 Hours This unit teaches research skills like proposal writing, literature review, data collection, questionnaire design, SPSS analysis, and qualitative data analysis. 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.

Quantitative Face Fit Testing Training (Train The Tester) Portacount Training

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Duration 1 Days 6 CPD hours This course is intended for The content is appropriate for test automation engineering roles, test manager roles, test lead roles, test architect roles, as well as developer roles. This course assumes you have a foundational understanding of testing and the purpose of automation. This course will be beneficial to anyone who is accountable for assessing, planning, designing, and implementing an integrated set of technology (testing infrastructure) that supports development, testing, and deployment. Overview Working in an interactive learning environment, led by our expert facilitator, attendees will learn to: Document the current state of test automation in your organization Define a custom test automation plan and architecture to fit their situation Create an initial implementation plan Identify initial key measures Develop a metrics dashboard for tracking the value of test automation Lay out a future strategy and roadmap to get there Introduction to Test Automation is a one-day, hands-on event designed to provide participants with the skills required to develop a custom test automation plan and architecture for their organization. Throughout the course, students will examine and work through various practical examples, learning how to create an integrated test automation plan and develop a test automation architecture. Participants will also learn about the possible real-world challenges they may face while trying to accomplish their goals, exploring the practical positive aspects of engaging their technical team, along with the possible frustrations of experiencing too much isolation between test automators and test designers. Getting Started Automation beginnings Software as a series of imperfect translations The Compelling Business Needs for Automation Automation the next opportunity Islands of Automation Getting products to market more quickly, at the right costs and quality Automation Challenges and Requirements Automation Challenges Test Automation Key Requirements Foundational material for your automation plan Templates Questions Examples Virtual Consulting included with this course Automation plan vision and strategy Vision, Strategy, Approach Example Defining your end in mind Deciding where to start Engaging Others Conducting a current state tools inventory Assessing your current state - tools and processes Tools inventory example and template Radar Chart as a means of presenting current state information Consider the best automation approach Waterfall vs. agile cycles of work Aligning tools with your methodologies Strategies for Automating The Test Automation Pyramid Developing your test automation architecture Blocks of automation capabilities Islands of Automation Integrated Tools Architecture Template Integrated Tools Architecture Examples Test automation architecture examples Examples of different test automation architectures and frameworks Selenium Key Test Automation Architecture Characteristics Acceptance test-driven and behavior-driven testing overview Test automation approaches FitNesse Cucumber Gherkin script overview Tool workflow Considerations for what to automate and when Categories of tests that might be automated We have many tool choices Key points in Test Tool Architecture Planning Piloting and Implementing automation Selecting and evaluating tools and rolling them out Selling Automation - qualitative questions Selling Automation - quantitative questions Measuring automation benefits Measures in technical terms Measures in business terms Measures of testing vs. measures of test automation Next Steps A few keys to success

Description: Six Sigma is a set of qualitative and quantitative quality tools that can help a business on improvement processes. The efficiency built into the business process brings about improved profits, confidence and quality. Growing your business through lean process improvement is an introduction to how any organization can use lean tools and techniques to improve profits. Six Sigma focuses in defects from variation. In statistics, the 'sigma' is used to identify variation. Companies that adopt Six Sigma as a philosophy seek to reduce variation in the business processes that cause waste and inefficiencies. In this Professional Diploma in Six Sigma & Lean you will learn all about Six Sigma and lean process. So, step ahead and grab this course now. Learning Outcomes: Realise the fundamentals of Six Sigma Relate the seven quality tools so that you can solve process problems Narrate the different quality management tools Explain incremental as well as breakthrough improvements along with understanding the terms of continuous improvement projects Pride explanation for the significance of customer relationships for a quality organization Define Lean and its key terms Describe the Toyota Production System and the TPS house Describe the five critical improvement concepts Use the Kano model Identify and reduce various types of waste Create a plan for a more environmentally Lean organization Use the PDSA and R-DMAIC- S models Use Lean thinking frameworks, including 5W-2H, Genchi Genbutsuand Gemba Prepare for and complete a basic 5-S Describe the key elements of Kaizen events, particularly a Kaizen blitz Gather, analyze, and interpret data using flow charts, Ishikawa(fishbone) diagrams, SIPOC diagrams, and value stream maps Go back to their organization with a plan to begin incorporating Lean into their corporate culture Relate to the consistent development with lean and what is all about Elaborate the concepts of the regular progress cycle: recognize,Plan, Application, and Recheck Implement Lean consistent development concepts for a case study Show ideas for consistent progress Assessment: At the end of the course, you will be required to sit for an online MCQ test. Your test will be assessed automatically and immediately. You will instantly know whether you have been successful or not. Before sitting for your final exam you will have the opportunity to test your proficiency with a mock exam. Certification: After completing and passing the course successfully, you will be able to obtain an Accredited Certificate of Achievement. Certificates can be obtained either in hard copy at a cost of £39 or in PDF format at a cost of £24. Who is this Course for? Professional Diploma in Six Sigma & Lean is certified by CPD Qualifications Standards and CiQ. This makes it perfect for anyone trying to learn potential professional skills. As there is no experience and qualification required for this course, it is available for all students from any academic background. Requirements Our Professional Diploma in Six Sigma & Lean is fully compatible with any kind of device. Whether you are using Windows computer, Mac, smartphones or tablets, you will get the same experience while learning. Besides that, you will be able to access the course with any kind of internet connection from anywhere at any time without any kind of limitation. Career Path After completing this course you will be able to build up accurate knowledge and skills with proper confidence to enrich yourself and brighten up your career in the relevant job market. Module 1 Six Sigma Basics 00:15:00 Improvement Tools 00:30:00 Management Tools for Generating Ideas 00:15:00 Continuous Improvement 00:30:00 Customer Relationships 00:30:00 Module 2 Understanding Lean 00:30:00 The Toyota Production System 00:30:00 The Toyota Production System House 00:15:00 The Five Critical Improvement Concepts 00:15:00 Understanding Value with the Kano Model 00:15:00 Types of Waste 00:15:00 Creating a Lean Enterprise 00:15:00 The Plan, Do, Study, Act (PDSA) Cycle 00:15:00 Using the R-DMAIC-S Model 00:15:00 Lean Thinking Tools 00:15:00 Kaizen Events 00:00:00 Data Gathering and Mapping 00:30:00 A Plan to Take Home 00:15:00 Module 3 Defining Continuous Improvement 00:15:00 Stage One - Identify Areas For Improvement 00:15:00 Stage Four - Review the Impact 00:15:00 Stage Three - Implement the Changes 00:15:00 Stage Two - Create a Plan for Improvement 00:15:00 Test Driving 00:15:00 Mock Exam Mock Exam- Professional Diploma in Six Sigma & Lean 00:30:00 Final Exam Final Exam- Professional Diploma in Six Sigma & Lean 00:30:00 Order Your Certificates and Transcripts Order Your Certificates and Transcripts 00:00:00

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