365 Courses

In this practical and engaging workshop there is input on team building, problem solving as a team, improving communication and handling conflict. This is participatory day of paper, pens, graphics, music and activity. There are no PowerPoint slides or even a projector and screen! Course Category Team Building and Leadership Early Years Inclusion Description Want a really creative, effective, inclusive team? In this practical and engaging workshop there is input on team building, problem solving as a team, improving communication and handling conflict. This is participatory day of paper, pens, graphics, music and activity. There are no PowerPoint slides or even a projector and screen! We keep the focus on interpersonal processes for getting the best out of the team. Making teams both creative and inclusive is fully explored and processes for maximising this examined. Effective leadership and management, which can transform teamwork through collaboration and consensus-building processes is covered. We refocus the team on its capacities and gifts as well as give insights into what to do when individuals are off track. The Native American medicine wheel guides us through four quadrants of leadership, vision, community and management.Harrison Owen in his work on ‘Open Space Technology’ depicts the ancient Medicine Wheel (Owen, 2003). This is derived from centuries of tradition among First Nation Americans and has informed many cultures in different ways. We have found this an extremely powerful metaphor for understanding the process of team and organisational change and renewal. The wheel of change begins in the north with a leading idea, for us – there is a better way of creating a team for inclusion. Travelling clockwise to the east we develop a shared vision of what this could look like in our setting, school or community. Then moving south we ask who needs to come with us on the journey. We wish to take as many community members along with us as we can. In an Early Years setting , this would mean enrolling the support of manager, the wider staff group, parents and ultimately children. Finally, at the west, we manage and implement the idea. We take action and turn the inclusive team into reality. The cycle of this medicine wheel is an excellent way to view change processes for any team, organisation or community. When we contemplate change, the risk is always that we will jump prematurely from the big ideas (leadership) to practice (management) and ignore the other two important phases of creating vision and engaging the wider community. When the going gets tough and the inclusion of a child or young person is beginning to seem extremely difficult if not impossible many will conclude that the child should no longer be present. We would like to challenge this. Why do we move so quickly to assuming the child is in the wrong place? Surely the real question should not be ‘do they belong here?’ – but rather – ‘what team support is needed here for this to work?’ Or even more fundamental, ‘who needs a team around them at this time?’ Who needs the team? Who is struggling with the inclusion most? Is it the young person, their practitioner or teacher, their headteacher, setting manager, their parent or even a member of the local support services? Whatever the answer a team may need to be built, rallied or reformed. The nature of and number of that team will depend upon the situation. Diversity of membership will most surely be important to strengthen the quality of the support and of the ideas generated. Use radical rethinking when creating a new team or when revitalising an existing one. Creating effective teams for inclusion requires a courageous capacity for understanding and nurturing change both within the team and with those who the team work with. Testimonials ‘What a fun, enjoyable day its been. Motivating and made me laugh not fall asleep!’?? ‘This was everything a team building day was supposed to be. I have learned a lot about the people I work with and my role within the organisation’ ‘I had reservations about attending yet another team building day but this was executed by two great facilitators and they worked with us so we truly understood what we were thinking and feeling.’ ‘Innovative and refreshing’ Learning Objectives Empowerment of team players Deepened insights into team processes Practical strategies for team building learned Processes for enhancing creativity of team members explored Celebration and recognition of existing strengths and talents   Who Is It For ? Any team Course Content This course answers the following questions: How can we re-energise our team? How can we make our team more inclusive? What tools can we use to work creatively in our team? We work around the ancient medicine wheel as it guides us through the four processes of leadership, vision, community and management. We place leading ideas in front of your team including ‘no kvetching’ and shared promises. We create a shared vision of how your team would love to be. We explore who the team is. When are they at their best? What happens when someone is off track? What do they really need? How do we take the community with us at a time of change? Finally we look at the management role of the team. Getting things done together. We use problem solving together as our focus for this. Finally your team will be asked to reflect. What has the training meant to them? If you liked this you may like: SUPPORT AND SUPERVISION FOR LEADERS

Microsoft Active Directory course description A thorough understanding of this system is essential for anyone managing enterprise MS networks. Essential theory is complimented with a high level of hands on practice allowing delegates to observe the idiosyncrasies of Active Directory and Group Policy at first hand. Delegates learn the fundamental theory of AD and progress onto building a multi-domain network in the classroom. The course includes troubleshooting methods, and essential maintenance procedures. This course is designed to teach you the skills needed for day to day management of these technologies. What will you learn Install AD on multiple PCs. Use the tools to create and manage objects. Create appropriate group policies to restrict selected user's desktops and network access. Install DNS to support Active Directory without loosing Internet Connectivity. Maintain and troubleshoot AD problems Backup Active Directory. Microsoft Active Directory course details Who will benefit: Technical staff working with AD based networks. Prerequisites: Supporting Windows server. Duration 3 days Microsoft Active Directory course contents Introduction to Active Directory Network authentication methods, Active Directory defined, AD naming conventions, network management with AD, AD structures: Domains, Organisational Units, Forests & Trees, Sites, The Global Catalogue. Windows 2003 new features, installing AD. Hands on Installing an AD network. Windows overview Management methods Server management tools, installing the additional tools, Terminal Server: Administration mode, Administrator accounts in AD, Local Security Policy. Hands on Install the management tools, Management using Terminal Services. Creating & Managing Objects (a quick look) AD management tools, AD users and computers, Creating & managing OUs, User Accounts and groups, controlling access to AD objects, moving objects, Publishing resources, locating objects in AD, delegating authority. Hands on Creating a control OU structure and delegating authority. Introduction to Group Policies What are Group Policies? Where Group Policy data is stored, security, Group Policy flow. Hands on Implementing Group Policies Working with Group Policies Local security templates, administrative templates, scripts, folder redirection, software deployment. Hands on Scripts, redirecting the start menu, creating a secure, robust desktop environment. Implementing DNS DNS basics, troubleshooting, implementing DNS zones. Hands on Building a unified DNS solution. Maintaining and managing the AD database AD support tools, database internal structure, replication, replication tools, Single Operations Masters, tools for maintenance, maintenance techniques, Backing up AD, Directory Services restore mode, NTDSUtil, Authoritative & non-authoritative restoration, rebuilding. Hands on NTDSUtil.

Click to read more about this training, in which we demonstrate a live problem solving approach which is based on the active participation of family members. Course Category Inclusion Parents and Carers Behaviour and relationships Problem Solving Description In this training we demonstrate a live problem solving approach which is based on the active participation of family members. ‘Family Circles’ is an evolving new approach to problem solving with families and is based on our years of family work and the development and use of the Circle of Adults process. Inspired by our own Parent Solutions work and the Circle of Adults process as well as Family Group Conferencing and other Restorative Interventions we bring you Family Circles. Essentially the approach involves gathering a family together for a process that is facilitated but majors on the family members offering each other their wisdom and ideas. The approach is capacity focused, person centred approach to working with families rather than the dominant deficit oriented and ‘medical model’ of viewing and planning for or doing things to families. This training can be modelled with a group of professionals or better still with a family. In our work with families we develop the importance of naming stories or theories and seeking linkages and synthesis between what is found out and explored about the family situation and its history. We like participants to sit with the uncertainty, to reflect on the question ‘why’ but without judgement of each other. Deeper reflections may span a whole range of perspectives from ‘within person’ considerations, to situational or systemic possibilities. Health or emotional issues can be reflected on alongside organisational or transactional aspects of what is going on for the family. The better the shared understanding the better the strategy or actions which emerge from these meetings. Quality hypotheses with a close fit to reality lead to more effective implementation in the real world. We encourage ‘loose’ thinking, a search for connections, deeper listening, an ‘open mind’, speculation and exploration without moral judgements. From this stance self-reflection as well as reflection on the situation can produce remarkable insights. The quality of theories or new stories generated is directly influenced by family members’ experiences and the models of learning, behaviour and emotion, systems, educational development, change and so on that they have been exposed to.  Learning Objectives To provide opportunities for: Shared problem solving in a safe exploratory climate in which the family will find its own solutions. Individuals to reflect on their own actions and strategies An exploration of whole-family processes and their impact Emotional support and shared understandings of issues at a child, parent, family, school and community level. Feed back to each other on issues, ideas and strategies that are agreed to be worth sharing with them. Who Is It For? Anyone interested in working with families in a way that builds and makes use of their capacities rather than focus on their challenges and difficulties. Social Care teams School staff Community organisers Educational Psychologists Course Content True family empowerment Deepening shared stories and understandings Facilitating groups Problem solving process Handling family group communication Allowing direct feedback and challenge between participants in a safe way Building relationships Process: Family members are welcomed: Introductions are carried out, ground rules and aims clarified whilst coffee is drunk. A recap from the last session is carried out: To follow up developments and reflections after the last meeting. One issue is selected for the main focus Issue presentation: The family member who raised the concern is asked questions to tell the ‘story’ of the issue or problem. Additional questions/information from the group about the problem are gathered: Ground rules may need to be observed carefully here. Individual participants need to be kept focused and prevented from leaping to premature conclusions or to making ‘helpful’ suggestions about strategy. Relationship aspects to the problem are explored. Metaphors and analogies are invited. How would a fly on the wall see your relationship? If you were alone together on a desert island, what would it be like? Impact of previous relationships/spillage from one relationship to another are explored. Eg what situation they are reminded of? For instance, does this situation remind you of any of those angry but helpless feelings you had with your other son when he was an adolescent? This provides opportunities to reflect on how emotions rub off on other people. The parent feels really frustrated, and on reflection we can see that so does the child System/Organisation factors (Family system/school and community systems and so on): What aspects help or hinder the problem? For instance, does the pastoral system of the local school provide space, or time and skilled personnel able to counsel this young person and work actively with their parents? Synthesis. At this stage the Graphic facilitator summarises what they have heard. They then go on to describe linkages and patterns in what they have heard. This can be very powerful. The person doing the graphic work has been able to listen throughout the presentation process and will have been struck by strong messages, emotions and images as they have arisen. The story and meaning of what is happening in the situation may become a little clearer at this point. Typical links may be ‘mirrored emotions’ strong themes such as loss and separation issues, or repeated processes such as actions triggering rejection. This step provides an excellent grounding for the next process of deepening understanding. What alternative strategies/interventions are open to be used? Brainstormed and recorded. ’Either/ors’ need to be avoided at this time also. This needs to be a shared session in which the family member who is presenting the concern contributes as much as anyone. Care is needed to ensure that this person is not overloaded with other people’s strategies. The final selection of strategy or strategies from the brainstormed list is the problem presenter’s choice. Strategies might include: a special time for the young person, a meeting with the child’s parents to explore how she is being managed at home and to share tactics, a home-school diary, counselling, or an agreed action plan that all are aware of, agreed sanctions and rewards and so forth. Strategies may productively involve processes of restitution and restoration, when ‘sorry’ is not enough. Making it right, rather than punishments or rewards, may then becomes the focus. First Steps. The problem presenter is finally asked to agree one or two first steps which they can carry out over the next 3-7 days. It can help to assign a ‘coach’ who will check in with them to ensure they have carried out the action they have named. This is a time to be very specific. Steps should be small and achievable. The person is just ‘making a start’. A phone call, or making an agreement with a key other person not present at the meeting would be ideal examples. Final reflections. Sometimes referred to as a ‘round of words’ help with closure for all involved. Reflections are on the process not the problem. In large families this is best done standing in a circle. In smaller groups all can remain sitting. Passing around a ‘listening stick’ or something similar such as a stone or light heighten the significance of the process ending and improve listening. Finally the problem presenter is handed the ‘Graphic’ this is their record of the meeting and can be rolled and presented ceremoniously by the facilitators for maximum effect! If you liked this course you may well like: Parent Solutions

ILM Level 5 Certificate in Leadership & Management – 9 day Accredited training course delivered in Nottingham This is a prestigious qualification for middle and aspiring middle managers. Participants should be operational managers with responsibilities for managing resources and/or teams of individuals within the scope of their role. Delegates are required to identify an opportunity for improvement in the organisation; research and analyse options and create an implementation plan for the business. Our client businesses tell us that this alone often pays many times over the for the course fee.

Students will learn and develop skills needed for a range of financial processes, including maintaining cost accounting records, advanced bookkeeping and the preparation of financial reports and returns.  Course Overview This qualification covers a range of essential and higher-level accounting techniques and disciplines. Students will learn and develop skills needed for a range of financial processes, including maintaining cost accounting records, advanced bookkeeping and the preparation of financial reports and returns. Study the Level 3 Diploma to learn higher accounting techniques and disciplines and qualify for AAT bookkeeping membership (AATQB). The jobs it can lead to: • Accounts assistant • Accounts payable clerk • Audit trainee • Credit controller • Payroll administrator/supervisor • Practice bookkeeper • Finance assistant • Tax assistant • Accounts payable and expenses supervisor Entry requirements: Students can start with any qualification depending on existing skills and experience. For the best chance of success we recommend that students begin their studies with a good standard of English and maths. Course Content: Business Awareness: This unit provides students with an understanding of the business, its environment and the influences that this has on an organisation’s structure, the role of its accounting function and its performance. Students will examine the purpose and types for businesses that exist and the rights and responsibilities of the key stakeholders, as well as gain an understanding of the importance of professional ethics and ethical management within the finance function. Learning outcomes: • Understand business types, structure and governance and the legal framework in which they operate. • Understand the impact of the external and internal environments on business, their performance and decisions. • Understand how businesses and accounts comply with principles of professional ethics. • Understand the impact of new technologies in accounting and the risks associated with data security. • Communicate information to stakeholders. Financial Accounting: Preparing Financial Statements: This unit provides students with the skills required to produce statements of profit or loss and statements for financial position for sole traders and partnerships, using a trial balance. Students will gain the double-entry bookkeeping skills needed to record financial transactions into an organisation’s accounts using a manual bookkeeping system. Learning outcomes: • Understand the accounting principles underlaying final accounts preparation. • Understand the principles of advanced double-entry bookkeeping. • Implement procedures for the acquisition and disposal of non-current assets. • Prepare and record depreciation calculations. • Record period end adjustments. • Produce and extend the trial balance. • Produce financial statements for sole traders and partnerships. • Interpret financial statements using profitability ratios. • Prepare accounting records from incomplete information. Management Accounting Techniques: This unit provides students with the knowledge and skills needed to understand the role of management accounting in an organisation, and how organisations use such information to aid decision making. Students will learn the principles that underpin management accounting methodology and techniques, how costs are handled in organisations and why organisations treat costs in different ways. Learning outcomes: • Understand the purpose and use of management accounting within organisations. • Use techniques required for dealing with costs. • Attribute costs according to organisational requirements. • Investigate deviations from budgets. • Use spreadsheet techniques to provide management accounting information. • Use management accounting techniques to support short-term decision making. • Understand principles of cash management. Tax Processes for Businesses: This unit explores tax processes that influence the daily operations of businesses and is designed to develop students’ skills in understanding, preparing and submitting Value Added Tax (VAT) returns to HM Revenue and Customs (HMRC). The unit provides students with the knowledge and skills that are needed to keep businesses, employers and clients compliant with laws and practices that apply to VAT and payroll. Learning outcomes: • Understand legislation requirements relating to VAT. • Calculate VAT. • Review and verify VAT returns. • Understand principles of payroll. • Report information within the organisation. DURATION 250-300 Hours WHATS INCLUDED Course Material Case Study Experienced Lecturer Refreshments Certificate

We communicate daily in many ways, including email, phone, text, Zoom, Teams, Google Meets, Slack, and even that old-fashioned thing, what was it now... oh yes, talking face-to-face. But, when we look at communication closely and really drill down into what we are doing in conjunction with how our brain works (neuroscience), how internal, organisational, and social politics control what we believe we can say, how hierarchical positioning impacts our honesty and how the lack of psychological safety means we say what we know others want to hear rather than what they need to hear…. It is oh so complicated! This workshop not only explores the concept of excellent communication, but we also want to hear what you believe it is too. We also delve into how organisational culture influences our perception of speaking up. Factors that hinder open and honest communication, and we work collaboratively towards removing these barriers to achieve a communication style that fosters trust and transparency, creating psychological safety. This workshop is particularly relevant to our Emotional Intelligence workshop (EI and Me). We firmly believe that developing emotional intelligence is the key to unlocking Clean Communication, a skill that is crucial for all of us, regardless of our roles and responsibilities, so that we thrive in our professional environment. If you want to see if we are correct, why not have us facilitate a workshop for you and see what you get by the end of it?  LENGTH - Normally, one day. But please contact us to discuss your specific needs, or we can offer advice. NEXT WORKSHOP START - Please ask for more information as we deliver bespoke closed events for your people at your location or a mutually suitable location. WORKSHOP DELIVERY - The best environment for this workshop is face-to-face, but we can facilitate this workshop online. Suitability - Who should attend? Who Should Attend and Why? Who? - Perhaps think of this another way… who shouldn’t attend to ensure we can attain Clean Communication? There’s your answer. Why? - Every person needs to understand what we are saying above about how we get trapped in this organisational formatting which changes how we communicate and how it prevents us from communicating cleanly. EVERY organisation has this, despite what our values profess. And 'Values', that’s a whole other story. Workshop Content Using the 'Moccasin Approach'® to clean our personal and organisational communication LaPD’s Communication Cycle and what we must consider. (Can you work out what the ? represent above? Accountability and Responsibility raises its head in Communication. It has to. Bias, unconscious bias and its impacts on our communication. The conundrum of communicating with others and their styles (The TRAP). How would my perfect Manager/Leader communicate with me? Nonverbal communication (body language), rapport, Clean Communication. Negative communication can go viral (Self-Fulfilling Prophecy). Reflections, findings and goals (individual and team). Meeting our workshop objectives by listing five areas for development. Workshop delivery and venue This workshop is usually one day in duration, and it focuses solely on how we communicate with each other. It can also be a two-day event incorporating aspects of Emotional Intelligence (EI) with group, and individual activities to allow discussions about the various communication we need in your organisation. When you consider the content we deliver, we are sure you will understand why we always prefer to deliver our workshops, courses and programmes face-to-face. Face-to-face workshops and courses can be held at a location of your choice or, if you wish, a central UK location, such as the Macdonald Burlington Hotel in Birmingham, located directly across from the Birmingham New Street train station. We can deliver our workshops, courses and programmes online, although this will mean splitting elements into manageable learning events to suit the online environment.

Management of Value (MoV®) Practitioner This interactive MoV® Practitioner course provides a modular and case-study-driven approach to learning Management of Value (MoV). The core knowledge is structured and comprehensive; and well-rounded modules cover the methodology and various techniques. A case study is used to help appreciate the relevance of MoV in its practical application. What you will Learn The MoV Practitioner Course prepares you for the MoV Practitioner exam. Individuals certified at the MoV Practitioner level will be able to: Apply Management of Value (MoV) principles, processes and techniques, and advocate the benefits of this application appropriately to the senior Management. Develop a plan of MoV activities for the whole lifecycle of small and large projects and programs. Plan an MoV study, tailoring it to particular projects or programs and developing practical study or workshop handbooks as required. Understand and articulate value in relation to organizational objectives. Prioritize value drivers using function analysis and use these to demonstrate how value might be improved. Quantify monetary and non-monetary value using the Value Index, Value Metrics and the Value for Money ratio. Describe and comment on the application of various techniques relevant to MoV. Monitor improvements in value realized throughout a project lifecycle and capture learning which can be transferred to future projects. Offer suggestions and guidance about embedding MoV into an organization, including policy issues, undertake a health check, assess maturity and competence, and provide guidance on typical roles and responsibilities. Understand and articulate the use of MoV within other Best Management Practice methods and its contributions to them Benefits of Taking This Course Upon successful completion of this course, you will be able to: Organise and contribute constructively to a Management of Value (MoV) Study Demonstrate a knowledge of MoV principles, processes, approach, and environment Analyse a company, programme or project to establish its organisational value includes identification and weighting of Value Drivers Pass the AXELOS Practitioner Examination Function Analysis Customer FAST Diagram Value Tree Development Weighting Attributes Paired Comparisons Developing a Value Profile Developing a Value Index Value for Money Ratio Stimulating Innovation Value Engineering Option Evaluation and Selection Evaluation Matrix Value and Value for Money Timing and Planning Teams and Stakeholders MoV in the Organization Integrating with Best Management Practice Relationship between Process and Approach

Management of Value (MoV®) Practitioner: In-House Training This interactive MoV® Practitioner course provides a modular and case-study-driven approach to learning Management of Value (MoV). The core knowledge is structured and comprehensive; and well-rounded modules cover the methodology and various techniques. A case study is used to help appreciate the relevance of MoV in its practical application. What you will Learn The MoV Practitioner Course prepares you for the MoV Practitioner exam. Individuals certified at the MoV Practitioner level will be able to: Apply Management of Value (MoV) principles, processes and techniques, and advocate the benefits of this application appropriately to the senior Management. Develop a plan of MoV activities for the whole lifecycle of small and large projects and programs. Plan an MoV study, tailoring it to particular projects or programs and developing practical study or workshop handbooks as required. Understand and articulate value in relation to organizational objectives. Prioritize value drivers using function analysis and use these to demonstrate how value might be improved. Quantify monetary and non-monetary value using the Value Index, Value Metrics and the Value for Money ratio. Describe and comment on the application of various techniques relevant to MoV. Monitor improvements in value realized throughout a project lifecycle and capture learning which can be transferred to future projects. Offer suggestions and guidance about embedding MoV into an organization, including policy issues, undertake a health check, assess maturity and competence, and provide guidance on typical roles and responsibilities. Understand and articulate the use of MoV within other Best Management Practice methods and its contributions to them Benefits of Taking This Course Upon successful completion of this course, you will be able to: Organise and contribute constructively to a Management of Value (MoV) Study Demonstrate a knowledge of MoV principles, processes, approach, and environment Analyse a company, programme or project to establish its organisational value includes identification and weighting of Value Drivers Pass the AXELOS Practitioner Examination Function Analysis Customer FAST Diagram Value Tree Development Weighting Attributes Paired Comparisons Developing a Value Profile Developing a Value Index Value for Money Ratio Stimulating Innovation Value Engineering Option Evaluation and Selection Evaluation Matrix Value and Value for Money Timing and Planning Teams and Stakeholders MoV in the Organization Integrating with Best Management Practice Relationship between Process and Approach

The Moccasin Manager, The Moccasin Approach, Management Training, Management Development,

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