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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

Gain the skills and credentials to kickstart a successful career and learn from the experts with this step-by-step

Gain the skills and credentials to kickstart a successful career and learn from the experts with this step-by-step

Boost Your Career By Enrolling In This Construction Safety (First Aid, Riddor, Loller, Fire safety, Working at Height) Bundle To Overcome Your Challenges! 20 in-1 Construction Safety (First Aid, Riddor, Loller, Fire safety, Working at Height) Bundle Secure your future in the construction industry with our comprehensive Construction Safety Bundle, covering First Aid, Riddor, Loller, Fire Safety, and Working at Height. In the UK, the demand for professionals trained in construction Safety is surging, with an estimated 7% job growth by 2025. Don't miss this chance to build a safer and more rewarding career. Enrol now and construct your path to success! 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This childcare bundle covers the following courses: Autism Diploma ADHD Awareness Course Nursery Nurse Dyslexia Early Years Level 4 Speech & Language Therapy Level 2 Diploma for the Early Years Practitioner Level 4 Diploma in Child Psychology Level 4 Diploma in Child Counselling Childcare and Nutrition Level 2 Safeguarding Children Training Course Child Protection and Risk Assessment Care and Support for Vulnerable Children Level 2 Certificate in Understanding Common Childhood Illnesses Affecting Children Child Sexual Exploitation & Child Criminal Exploitation (CSE & CCE) Awareness Training Level 2 Award in Babysitting Level 2 Award in Preparation for the Responsibilities of Parenting Level 1 Award in Working With Children Level 3 Award for Special Educational Needs Coordinators in Early Years Settings Entry Level 3 Award In Skills for Childcare Level 5 Childcare Training Level 1 First Award in Children's Play Learning and Development Advanced Diploma in Child care Entry Level 2 Extended Award in Skills for Working in Child Care Industries Level 2 Behaviour Management in the Early Years Assessment Method After completing each module of the Child Care Bundle, you will find automated MCQ quizzes. To unlock the next module, you need to complete the quiz task and get at least 60% marks. Once you complete all the modules in this manner, you will be qualified to request your certification. Certification After completing the MCQ/Assignment assessment for this Child Care Bundle course, you will be entitled to a Certificate of Completion from Training Tale. It will act as proof of your extensive professional development. The certificate is in PDF format, which is completely free to download. A printed version is also available upon request. It will also be sent to you through a courier for £13.99. Who is this course for? This childcare bundle course is suitable for anybody wishing to turn a love for caring for others into a fulfilling job for life. This bundle was created with total flexibility and accessibility in mind. It is also appropriate for both newbies to the topic and established workforce members. 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The course "Understanding Investments" aims to provide students with an overview of investment fundamentals and concepts, enabling them to understand various investment options, evaluate investment risks, and develop investment strategies.After the successful completion of the course, you will be able to learn about the following, Analyse Investment options. Understand the difference between Real and Financial Assets and the concept of Return and Risk. Understand and apply the principles of Asset Allocation, Portfolio Management. Appraise different Investment Models. Manage Risk in investments. The course "Understanding Investments" is designed to introduce students to the world of investing. The course covers various topics like investment analysis, portfolio management, and risk assessment. Students will learn to evaluate investment options, understand financial markets, and develop investment strategies. The course will equip students with the knowledge and skills to make informed investment decisions. The course "Understanding Investments" is designed to introduce students to the world of investing. The course covers various topics such as investment analysis, portfolio management, and risk assessment. Students will learn how to evaluate investment options, understand financial markets, and develop investment strategies. The course will equip students with the knowledge and skills necessary to make informed investment decisions. VIDEO - Course Structure and Assessment Guidelines Watch this video to gain further insight. Navigating the MSBM Study Portal Watch this video to gain further insight. Interacting with Lectures/Learning Components Watch this video to gain further insight. Understanding Investments This course prepares you for investment-related concepts and skills. Understanding Investments Put your knowledge to the test with this quiz. Read each question carefully and choose the response that you feel is correct. All MSBM courses are accredited by the relevant partners and awarding bodies. Please refer to MSBM accreditation in about us for more details. 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 learner's knowledge in the field. This certificate is for everyone eager to know more and get updated on current ideas in their respective field. We recommend this certificate for the following audience. CEO, Director, Manager, Supervisor Investment Analyst Portfolio Manager Financial Advisor Wealth Manager Investment Banker Asset Manager Equity Research Analyst Hedge Fund Manager Private Equity Associate Risk Analyst Average Completion Time 2 Weeks Accreditation 3 CPD Hours Level Advanced Start Time Anytime 100% Online Study online with ease. Unlimited Access 24/7 unlimited access with pre-recorded lectures. Low Fees Our fees are low and easy to pay online.

Risk Management: Diploma in Risk Management Training If you want to learn about Risk management and become an expert in the field, you have arrived at the right place. Our Risk Management: Diploma in Risk Management Training course is a great way to brush up on your knowledge and skills. With this Training Tale Risk Management: Diploma in Risk Management Training Course, you will get a solid introduction on the topic of risk management and learn how to conduct a risk assessment. Our Risk Management: Diploma in Risk Management Training course will also teach you about the various types of risks that your company may face. With this Risk Management: Diploma in Risk Management Training course, you will learn about the benefits of risk management and the steps of the risk assessment process. Learners are led through the key roles and obligations of those employed in professional Risk Management throughout 17 motivating modules. Industry experts designed this Risk Management: Diploma in Risk Management Training course to enable you to learn quickly and efficiently and at your own pace and convenience. Enrol today and take the next step towards your personal and professional goals. Courses are included in this Risk Management: Diploma in Risk Management Training Course Course 01: Diploma in Risk Management Course 02: Level 2 Diploma in Business Administration Course 03: Level 7 Diploma in Facilities Management Course Special Offers of this Risk Management: Diploma in Risk Management Training Course This Risk Management: Diploma in Risk Management Training Course includes a FREE PDF Certificate. Lifetime access to this Risk Management: Diploma in Risk Management Training Course Instant access to this Risk Management: Diploma in Risk Management Training Course Get FREE Tutor Support from Monday to Friday in this Risk Management: Diploma in Risk Management Training Course [ Note: Free PDF certificate as soon as completing the Risk Management: Diploma in Risk Management Training course] Risk Management: Diploma in Risk Management Training Industry Experts Designed this Risk Management: Diploma in Risk Management Training Course into 17 detailed modules. Course Curriculum of Diploma in Risk Management Training Module 01: A Quick Overview of Risk Management Module 02: Risk and its Types Module 03: Other Types of Risks and its Sources Module 04: Risk-Management Standards Module 05: Enterprise Risk-Management Module 06: Process of the Risk-Management Module 07: Risk Assessment Module 08: Risk Analysis Module 09: Financial Risk Management Module 10: The Basics of Managing Operational Risks Module 11: Technology Risk-Management Module 12: Project Risk-Management Module 13: Legal Risk-Management Module 14: Managing Social and Market Risk Module 15: Workplace Risk Assessment Module 16: Risk Control Techniques Module 17: Ins and Outs of Risk Management Plan Assessment Method of Diploma in Risk Management Training After completing each module of the Risk Management: Diploma in Risk Management Training Course, you will find automated MCQ quizzes. To unlock the next module, you need to complete the quiz task and get at least 60% marks. Certification of Diploma in Risk Management Training After completing the MCQ/Assignment assessment for this Risk Management: Diploma in Risk Management Training course, you will be entitled to a Certificate of Completion from Training Tale. The certificate is in PDF format, which is completely free to download. A printed version is also available upon request. It will also be sent to you through a courier for £13.99. Who is this course for? Risk Management: Diploma in Risk Management Training Risk Management: Diploma in Risk Management Training course is ideal for- Fresh Graduates, Students, Job Seekers, anyone interested in risk management, Quality Managers, Quality Assurance professionals, People who are already employed in related fields and want to improve their expertise and skills. Requirements Risk Management: Diploma in Risk Management Training Students who intend to enrol in this Diploma in Risk Management: Diploma in Risk Management Training Course must meet the following requirements: Risk Management: Good command of the English language Risk Management: Must be vivacious and self-driven. Risk Management: Basic computer knowledge. Risk Management: A minimum of 16 years of age is required. Career path Risk Management: Diploma in Risk Management Training Candidates who successfully complete our Risk Management: Diploma in Risk Management Training can advance a huge variety of careers, including:- Quality Manager, Quality Assurance Manager, Risk Management Manager, Risk Manager, Risk-Management Consultant, Risk-Management Analyst Certificates Certificate of completion Digital certificate - Included

Course Curriculum Module 1 Introduction to Debt Management Introduction to Debt Management 00:00 Module 2 Debt in Corporate Finance Debt in Corporate Finance 00:00 Module 3 Understanding Debt Instruments and Securities Understanding Debt Instruments and Securities 00:00 Module 4 Debt Valuation Methods Debt Valuation Methods 00:00 Module 5 Debt Portfolio Management Debt Portfolio Management 00:00 Module 6 Credit Risk Assessment and Ratings Credit Risk Assessment and Ratings 00:00

2 QLS Endorsed Courses | CPD Certified | Free PDF & Hard Copy QLS Certificates | 180 CPD Points | Lifetime Access