689 Other courses in St Neots

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

Intercultural Competence: In-House Training In a world that conducts business across continents and geographical borders, more than ever it is essential for team and organizational leaders to not only understand but also embrace the diversity of cultures; this is intercultural competence. Intercultural competence gives one the ability to effectively and appropriately communicate with people from other cultures in a competitively complex world. The participant in this program will gain cultural insights needed to build intercultural teams and navigate cultural diversities, without knowingly violating what are deemed to be acceptable or unacceptable cultural norms. What you will Learn At the end of this program, you will be able to: Articulate on the meaning of culture and intercultural competence Express the importance of body language and appropriately demonstrate its emblems Describe three cultural models and consider their application in assimilating cultural behaviors Define emotional intelligence and explain how it is linked to cultural intelligence Examine the four cultural intelligence capabilities and give examples of how each is developed Develop a personal cultural profile and compare its dimensions to gain an appreciation for intercultural competence Foundation Concepts Fundamentals of culture Culture and body language Culture and proxemics Cultural Models Iceberg culture model The onion model of culture Hofstede's model of national cultures High-context and low-context cultures Cultural Intelligence Emotional intelligence overview Cultural intelligence overview Cultural Profile Cultural profile dimensions Understanding your cultural profile

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If you want to be able to offer a consistently better quality of education for your pupils without the stress that comes with worrying about Ofsted all the time, this workshop is for you.

This is a practical ‘non medical’ day for front line practitioners working with children and young people with serious attachment issues arising from loss, trauma and abuse. We look at what Psychology may help us in our understanding of children who have faced issues with love and attachment. Splitting, handling projected feelings, constancy and permanence are explored. Online Course now available via Teachable Platform – Understanding Attachment Learn at your own pace… lots of text and video support Course Category Meeting emotional needs Behaviour and Relationships Inclusion Teaching and Learning Description This is a practical ‘non medical’ day for front line practitioners working with children and young people with serious attachment issues arising from loss, trauma and abuse. Drawing from the international research and literature and our own experience over many years as educational psychologists of the challenges of children with major social and emotional needs, we will explore together what the best practice can and could look like. We explore the language of attachment and outline very practical classroom strategies. We look at what Psychology may help us in our understanding of children who have faced issues with love and attachment. We explore the feelings of being on a desolate island of relational poverty or to imagine swimming with sharks. We explore the themes of violence, anxiety and experience of being a victim as young people grow older. We look at telling lies and explore how we can respectfully understand this. We reveal the new and innovative compass of vulnerability – the cognitive errors to which some are much more vulnerable. We look at triggers, self regulation and unpack a range of strategies.  Transference and counter transference are examined along with splitting, handling projected feelings, constancy and permanence. We explore what young people with these difficulties really need from us. We also spend time looking at the emotional impact on practitioners working with children with such needs and what helps at an personal and team level. We can all do something – we do not have to wait for expert therapists to arrive!  Testimonials Very moving presentation I will always try and think behind the behaviour now It had a huge impact on all levels We all seem to need it Belonging and feelings are so important Very user friendly Excellent! Learning Objectives Increased confidence regarding developing inclusive practice for children with serious attachment needs in mainstream schools Simple understandable explanation of attachment understood Access to a wider range of practical strategies to impact on social and behavioural needs Deeper understanding of core values surrounding inclusion of emotionally disabled children Opportunity to reflect on professional attitudes and behaviour towards parents and pupils with complex emotional needs New skills, scripts and processes to make inclusion successful Who Is It For ? Practitioners working in schools and other settings with children and young people of all ages Key workers Teaching Assistants with support roles Heads and deputies SENCOs Advanced skills teachers Primary and secondary classroom teachers Parents Local authority support services Course Content The course explores the questions : How can we start to develop an understanding of children with attachment needs? What is the true impact of loss, trauma and abuse? What else can we do to go about including high profile children or young people with challenging emotional needs? What useful psychological constructs can we use to guide us? This course also explores practical strategies and language for key adults rebuilding relationships with individual pupils. This is a participative day that aims to be explorative and practical. Opportunities to develop empathy with the children of concern will be created.

Gain essential knowledge and skills to recognise, manage, and provide prompt emergency treatment for adrenal crisis with our course. Ideal for healthcare professionals.

Use Cases for Business Analysis: In-House Training The use case is a method for documenting the interactions between the user of a system and the system itself. Use cases have been in the software development lexicon for over twenty years, ever since it was introduced by Ivar Jacobson in the late 1980s. They were originally intended as aids to software design in object-oriented approaches. However, the method is now used throughout the Solution Development Life Cycle from elicitation through to specifying test cases, and is even applied to software development that is not object oriented. This course identifies how business analysts can apply use cases to the processes of defining the problem domain through elicitation, analyzing the problem, defining the solution, and confirming the validity and usability of the solution. What you will Learn You'll learn how to: Apply the use case method to define the problem domain and discover the conditions that need improvement in a business process Employ use cases in the analysis of requirements and information to create a solution to the business problem Translate use cases into requirements Getting Started Introductions Course structure Course goals and objectives Foundation Concepts Overview of use case modeling What is a use case model? The 'how and why' of use cases When to perform use case modeling Where use cases fit into the solution life cycle Use cases in the problem domain Use cases in the solution domain Use case strengths and weaknesses Use case variations Use case driven development Use case lexicon Use cases Actors and roles Associations Goals Boundaries Use cases though the life cycle Use cases in the life cycle Managing requirements with use cases The life cycle is use case driven Elicitation with Use Cases Overview of the basic mechanics and vocabulary of use cases Apply methods of use case elicitation to define the problem domain, or 'as is' process Use case diagrams Why diagram? Partitioning the domain Use case diagramming guidelines How to employ use case diagrams in elicitation Guidelines for use case elicitation sessions Eliciting the problem domain Use case descriptions Use case generic description template Alternative templates Elements Pre and post conditions Main Success Scenario The conversation Alternate paths Exception paths Writing good use case descriptions Eliciting the detailed workflow with use case descriptions Additional information about use cases Analyzing Requirements with Use Cases Use case analysis on existing requirements Confirming and validating requirements with use cases Confirming and validating information with use cases Defining the actors and use cases in a set of requirements Creating the scenarios Essential (requirements) use case Use case level of detail Use Case Analysis Techniques Generalization and Specialization When to use generalization or specialization Generalization and specialization of actors Generalization and specialization of use cases Examples Associating generalizations Subtleties and guidelines Use Case Extensions The <> association The <> association Applying the extensions Incorporating extension points into use case descriptions Why use these extensions? Extensions or separate use cases Guidelines for extensions Applying use case extensions Patterns and anomalies o Redundant actors Linking hierarchies Granularity issues Non-user interface use cases Quality considerations Use case modeling errors to avoid Evaluating use case descriptions Use case quality checklist Relationship between Use Cases and Business Requirements Creating a Requirements Specification from Use Cases Flowing the conversation into requirements Mapping to functional specifications Adding non-functional requirements Relating use cases to other artifacts Wire diagrams and user interface specifications Tying use cases to test cases and scenarios Project plans and project schedules Relationship between Use Cases and Functional Specifications System use cases Reviewing business use cases Balancing use cases Use case realizations Expanding and explaining complexity Activity diagrams State Machine diagrams Sequence diagrams Activity Diagrams Applying what we know Extension points Use case chaining Identifying decision points Use Case Good Practices The documentation trail for use cases Use case re-use Use case checklist Summary What did we learn, and how can we implement this in our work environment?

In this course, students will learn general strategies for planning, designing, developing, implementing, and maintaining an IoT system through various case studies and by assembling and configuring an IoT device to work in a sensor network.

Can be run as a one day or two day course. Whereas the one day course concentrates on Speaking Skills in delivering a talk and allows time for participants to prepare and deliver a very short talk, the two day course offers the opportunity for participants to deliver a longer (15 minute) talk and includes consideration of other situations where speaking skills are important such as talking in meetings, talking at interviews etc.