This Level 4 Certificate in Education and Training qualification (accredited by Qualifi) has been created to further develop practical teaching skills, assessment and the use of resources in education and teaching. This Level 4 Certificate in Education and Training online qualification is suitable for those who work, or want to work as teachers/trainers in the further education and skills sector; learners who have just started a teaching/training role; teachers/trainers who are seeking career progression in their area of work; those working with learners on a one-to-one basis; learners who teach in industry; assessors who wish to achieve a teaching/training qualification. Key Highlights of Level 4 Certificate in Education and Training qualification are: Program Duration: 6 Months (Fast track mode available) Program Credits: 36 Designed for working Professionals or for those who work, or want to work as teachers / trainers in the further education and skills sector Format: Online No Written Exam. The Assessment is done via Submission of Assignment Tutor Assist available Dedicated Student Success Manager Timely Doubt Resolution Regular Networking Events with Industry Professionals Become eligible to gain direct entry into relevant Undergraduate degree programme. Alumni Status No Cost EMI Option Requirements This Level 4 Certificate in Education and Training (Accredited by Qualifi) qualifications has been designed to be accessible without artificial barriers that restrict access and progression. Learners will be expected to hold the following: Learners who have demonstrated some ability and possess Qualifications at Level 3 for example 'A' Levels or vocational awards; and/or OR work experience in a business environment and demonstrate ambition with clear career goals; Level 4 qualification in another discipline and want to develop their careers in management. Career path Learners completing the Level 4 Certificate in Education and Training can progress to: Level 5 Diploma in Education and Training The Second year of an Undergraduate Degree, or Level 5 Diploma qualifications (click here to view) Directly into employment in an associated profession. Certificates Certificate of Achievement Hard copy certificate - Included Qualifi courses: Once you complete the course, you would be receiving a Physical hard copy of your Diploma along with its Transcript which we would Courier to your address via DHL or Royal Mail without any additional charge.
The Preliminary Electronic Security Course is an introductory (or revision) course designed to provide participants who have no previous Electrical or Electronics experience with the background skills required to attend the CCTV Installation Course, Access Control Course or Fire Alarm Foundation Course. The course gives both an introduction to electronics and electronic security and shows how the two fields merge together. Ideal for a beginner wishing to learn more about this fascinating area. A large practical content is guaranteed. The day will be an excellent learning experience with a skilled instructor. It is a great introduction to the other courses we provide.
The Microsoft Certified Associate is a new breed of Microsoft certification. It is referred to as a ‘role-based certification’. According to Microsoft, role-based certifications show that individuals that possess them are keeping pace with today’s technical roles and requirements. They allow a learner to skill up and prove their expertise to employers and peers, plus get the recognition and opportunities they’ve earned
Peering at LINX training course description A one or two day induction course covering the technical procedures of LINX along with correct interaction with LINX and LINX members. This course focuses on the implementation of the technologies within the LINX network. For those already competent in BGP the one day version of this course is sufficient. What will you learn Explain the role of LINX in the Internet. Correctly connect to LINX. Recognise the correct procedures for peering at LINX. Use the current Best Current Practices. Peering at LINX training course details Who will benefit: Technical staff of new LINX members. Technical staff of companies preparing to join LINX. Non technical staff may also benefit from this course. Prerequisites: None. (For technical staff with BGP knowledge 1 day) Duration 1 to 2 days Peering at LINX training course contents Introduction and review Networks, The Internet, IP, routers, Autonomous systems, the structure of the Internet, the role of Internet Exchanges. BGP and peering. LINX, EuroIX, RIPE. What you get when you join LINX. LINX products: Connexions, Virtual PoPs, Colocation resales, LINX from anywhere. LINX infrastructure The original architecture, The growth of LINX, the current topology. LINX London locations. Dual LAN topology. LON1, LON2. Use of MPLS to connect London sites. Regional peering: LINX NoVa, LINX Manchester, LINX Wales, LINX Scotland, ManxIX, JEDIX. Connecting with LINX nnecting with LINX Locations. 1/10/100/400G. Interface specifications. Link aggregation. The racks and space provided, access to the racks, connecting WAN circuits into LINX. The connection form, How to link your ISP with LINX, switch assignments, limits on traffic, average measured traffic, getting statistics from LINX, Using looking glass. Allowed traffic. Port security Configuration hints LINX IP details, IPv4, IPv6, PTR records, Cisco base configuration, Juniper base configuration. Peering with other LINX members Preparing for peering, the peering template, setting up the peering, RFC 2142, the RIPE database, contacts, peeringdb.net, solving downed BGP sessions, escalation procedures. Peering configuration hints Cisco BGP configuration, Juniper BGP configuration. LINX additional services Private interconnect, LINX time service. NTP, Strata. The LINX route server Bi lateral peering, Multi lateral peering. How the LINX route server is configured. Use of communities on the route server, template for peering with the route server. Summary Getting further information, the LINX website, the LINX mailing lists.
Duration 4 Days 24 CPD hours This course is intended for Security Engineers Security Administrators Security Operations Specialists Security Analysts Network Engineers Overview Successful completion of this four-day, instructor-led course will help enhance your understanding of how to better protect your applications, remote networks, and mobile users using a SASE implementation. You will get hands-on experience configuring, managing, and troubleshooting Prisma Access in a lab environment. The Prisma Access SASE Security: Design and Operation (EDU-318) course describes Prisma Access Secure Access Service Edge (SASE) and how it helps organizations embrace cloud and mobility by providing network and network security services from the cloud. This course is intended for people in the fields of public cloud security and cybersecurity, or for anyone who wants to learn how to secure remote networks and mobile users. Course Outline 1 - Prisma Access Overview and Definitions 2 - Planning and Design Architecture 3 - Routing SD-WAN Design and CloudGenix 4 - Activate and Configure Service Connections 5 - Rule Enforcement in Prisma Access and SSL Decrypt 6 - Panorama Operations for Prisma Access and Fawkes Overview 7 - Remote Networks 8 - Mobile Users 9- Cloud Secure Web Gateway 10 - Tune, Optimize and Troubleshoot 11 - Manage Multiple Tenants 12 - What?s New in v2.1 13 - Next Steps Additional course details: Nexus Humans Palo Alto Networks: Prisma Access SASE Security: Design and Operation EDU-318 (3.2) training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the Palo Alto Networks: Prisma Access SASE Security: Design and Operation EDU-318 (3.2) course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.
Course Information Embark on our GLP course offering extensive guidance and pragmatic support tailored for individuals serving as Study Directors or Principal Investigators overseeing non-clinical safety studies on pharmaceuticals, agricultural, and industrial chemicals within the realm of Good Laboratory Practice (GLP). This comprehensive programme extends its benefits to study staff and management operating in GLP-compliant environments. The course extensively covers the current OECD GLP Principles and UK GLP legislation, while also referencing international standards, regulations, and guidelines pertinent to the field. Benefits of this course: Practical help and guidance on the interpretation and application of GLP An opportunity to update your knowledge of GLP with the current interpretation of requirements Access to an experienced panel of speakers Information on how other organisations address GLP issues An opportunity to improve your understanding of the GLP requirements as they are applied in different situations. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Examine particular aspects of GLP Learn from the experience of others. Tutors Tutors will be comprised of (click the photos for biographies): Tim Stiles Consultant, Qualogy Ltd Tony Woodall Head of Quality Assurance, Alderley Analytical Gill Armour Study Monitor Team Leader, AstraZeneca Jane Elliston Senior Quality Assurance Auditor, Battelle UK Vanessa Grant -, - Jeanet Logsted CEO, Scantox Programme Please note timings may be subject to alteration. Day 1 09:00 Registration 09:15 Welcome and Introductions 09:35 Development of Good Laboratory Practice A review of the history of GLP, its current scope and application, with a synopsis of current European and international standards. 10:05 Roles and Responsibilities The responsibilities of study director, test facility, management and study staff in the conduct of a GLP study. 10:45 Break 11:00 The Roles and Responsibilities of the Study Director and Test Facility Management The role of the study director in the management and control of a study, as defined by GLP, and management's roles are explored. 11:45 Multi-site Studies What is a multi-site study and when should such concepts be applied on a study. The role of the study director and principal investigator in the planning, conduct and reporting of multi-site study are explored. 12:30 Study Plan (Protocols) GLP requirements for the preparation of a study plan, content, authorisation, amendments and deviations are discussed. 13:00 Lunch 13:45 Workshop 1 - The Study Plan Some practical problems with study plans and amendments explored. 14:45 Workshop 1 - Feedback 15:00 Standard Operating Procedures The control, content and authorisation of SOPs and the principles behind the practice. 15:30 Break 15:45 Workshop 2 - Practical Study Conduct Problems Dealing with practical problems encountered during the conduct of studies. 16:40 Workshop 2 - Feedback 17:15 Close of Day Day 2 09:00 Questions and Answers Discussion of issues raised by course delegates. 09:20 Quality Assurance The interactions between QA, management, study director and principal Investigator are discussed as is QAs role when conducting a multi-site study. 10:00 The Final Report The content of the final report and the role of those involved in its preparation and approval. Specific reporting requirements when conducting a multi-site study are also explained. 10:30 Break 10:45 Workshop 3 - Final Report Problems Practical problems of report preparation including compliance statements. 11:30 Workshop 3 - Feedback 12:00 Management of Raw Data and Records A view on how records and materials are managed and archived in compliance with GLP. 12:45 Lunch 13:30 Workshop 4 - Data and Sample Management Issues Dealing with data and sample management issues. 14:15 Workshop 4 - Feedback 14:45 Regulatory Inspection Government monitoring for compliance with Good Laboratory Practice. 15:15 Panel Session This panel session will address any outstanding issues raised by delegates. 15:45 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. 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. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote 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 14 Points Development Level Develop
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
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
The course is relevant to anyone requiring an understanding of the use of Agile or looking to adopt it. This includes, but is not limited to, organisational leaders and managers, marketing executives and managers, and/or all professionals working in an Agile environment, including software sesters, developers, business analysts, UX designers, project management office (PMO), project support and project coordinators.