1693 Courses

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

PRINCE2 is a process-based project management methodology that offers a flexible and scalable solution to handle all kinds of projects. This is why many organisations favour it since it fosters better collaboration between team members and external stakeholders. Course Overview PRINCE2 is a process-based project management methodology that offers a flexible and scalable solution to handle all kinds of projects. This is why many organisations favour it since it fosters better collaboration between team members and external stakeholders. The PRINCE2 certification will surely help learners advance in terms of worth and employment opportunities if they list it as a skill in their resumes. This 3-day introductory PRINCE2® Foundation course is designed to give candidates a comprehensive overview of the PRINCE2® methodology. They will learn about various essential topics such as integrated elements, applying PRINCE2®, delivery approaches, processes, principles, tailoring, etc. The PRINCE 2 foundation course will introduce project management to students. This course will focus on different aspects of project management, providing the knowledge, tools and techniques used to understand each concept and methodology. At the end of this PRINCE2® Foundation course, delegates will be able to perform various project manager activities in an organisation effectively and efficiently. They will also be able to use various PRINCE2® methodologies properly. This training will also cover the following concepts: • Project management • Projects in context • Measuring success • Tailor to suit the project • Embedding PRINCE2® • Tailoring constraints and influences Who it’s for? Prerequisites: In this PRINCE2® Foundation course, there are no formal prerequisites. PRINCE2 Foundation can be studied on its own or as a prerequisite for the PRINCE2 Practitioner course This PRINCE2® Foundation course is designed for anyone who wants to gain in-depth knowledge about project management methodologies. What's Included in this PRINCE2 Foundation Training Course? The following is included in this PRINCE2® Foundation training course: • PRINCE2® Foundation Examination • Pre-course material • PDUs • Experienced PRINCE2® Instructor • Certificate • Refreshments PRINCE2® Foundation Exam: The PRINCE2® Foundation examination Focuses on knowledge of PRINCE2® as a methodology. • Type of Questions: Multiple choice. • Total Questions: 60. • Number of marks: 60 marks, each question is worth 1 mark. • Pass mark: 55%, or 33/60. • Duration: 60 Minutes. • Material allowed: No, this is a ‘closed book’ exam. This PRINCE2® foundation training course covers the following topics: Module 1: Introduction to Projects and the PRINCE2® Methodology: • PRINCE2® “Project” Definition • Project Characteristics • Project Management • What is PRINCE2®? • Four Integrated Elements • What Does PRINCE2® Not Provide? • What Makes a Project a PRINCE2® Project? Module 2: Project Manager Activities: • Customer/Supplier Environment • Projects in Context • Commercial Environment • Applying PRINCE2® • Delivery Approaches • Measuring Success • Organisational Capability • Seven Processes Module 3: Seven Themes: • Business Case • Organisation • Quality • Plans • Risk • Change • Progress Module 4: Seven Principles: • Continued Business Justification • Learn from Experience • Defined Roles and Responsibilities • Manage by Stages • Manage by Exception • Focus on Products • Tailor to Suit the Project Module 5: Considerations for Organisational Adoption: • Creating a PRINCE2® Based Project Management Method • Creating Tailoring Rules and Guidelines • Rating the Complexity of Projects • Embedding PRINCE2® • Tailoring • What Should Be Tailored? • Tailoring Constraints and Influences • Creating an Organisation’s Method DURATION 2-3 days WHATS INCLUDED Course Material Case Study Experienced Lecturer Refreshments Certificate

The CILT(UK) Level 5 Professional Diploma in Logistics and Transport (QCF) is designed to enhance new and existing expertise in the supply chain, passenger transport, road freight or transport planning environments as well as developing core management skills.

These qualifications are designed for Directors and Senior Managers who have the authority across organisational and personal inspiration to translate organisational strategy into effective performance. The qualifications require directors and senior managers to build on their skills in strategic direction and leadership and to focus on the requirements of inter-organisational strategy. Equivalent to a Doctorate in Management, this Level 8 Strategic Direction and Leadership course is designed for Directors and Senior Managers with responsibility for developing and implementing ethical and performance-driven strategy across multiple organisations, leading by example to inspire teams and provide clear direction. CMI qualifications at RQF Level 8 portray practice skills and competencies that are rated in academic terms as being comparable to Doctoral Degrees and Vocational Qualifications at Level 8. Study method Online, self-paced Duration 9 months Access to content Access until course completion Qualification CMI Level 8 Diploma In Strategic Direction and Leadership CPD 670 CPD hours / points Additional info Exam(s) / assessment(s) is included in price Tutor is available to students How Will I Benefit? The CMI Level 8 Strategic Direction and Leadership will develop the advanced skills and knowledge that you need to lead transformational strategic change within your organisation(s), accelerating performance in multiple settings Apply the tools, models and theories directly to real-life work-based problems and see the benefits in your organisation This CMI distance learning course will demonstrate to current and prospective employers your capabilities, ambition and commitment to professional development Achieve the highest level of strategic learning, significantly improving your career prospects and earning power CMI Level 8 Diploma in Strategic Direction and Leadership Learners need to complete all Group A units and any combination of units to a minimum of 7 credits from Group B. Learners need it complete a total of 67 credits to achieve this qualification. The Total Qualification Time is 670 hours, including 210 Guided Learning Hours. UNIT NUMBER UNIT NAME CREDITS GLH TUT Group A Unit 8001V1 Personal development as a strategic leader 10 30 100 Unit 8002V1 Collective strategy development 10 30 100 Unit 8003V1 Inter-organisational strategic planning 10 30 100 Unit 8004V1 Inter-organisational strategic direction 10 30 100 Unit 8005V1 Strategic communication 10 30 100 Unit 8006V1 Strategic culture 10 30 100 Group B Unit 7013V1 Strategic leadership 7 30 70 Unit 7014V1 Strategic leadership practice 7 30 70 NB - If you have achieved either of the Group B Units as part of a Level 7 qualification you do not have to repeat them. Who is this course for? This qualification is not aimed at managers aspiring to a senior management role it is targeted at individuals already employed in a strategic leadership position for a minimum of 3 years. Requirements Ability to complete assignments at post-graduate level. All Learners must hold a Level 7 or equivalent qualification. At least 3 years’ experience at strategic level as a senior manager. Career path This qualification can significantly improve your career prospects, promotional prospects, salary, self-confidence and self-esteem as a senior manager and leader.

Coaching, Workplace coaching, Floor walking coaching, Organisational coaching,

Mediation for Managers Training

Effective cross-cultural management and leadership demand an understanding of the complexities of culture from structural, political, social and psychological perspectives An intensive 3-day training course from one of the leading providers of cross- cultural leadership and management training. Designed for individuals wishing to develop and their skills in managing and leading in a cross-cultural environment. Introduction Created specifically for the cross‐cultural workplace setting and utilising a blend of interactive role play, DVD presentations and case‐study based discussion, the course provides comprehensive skills training for anyone who must manage or lead a cross‐cultural team or employees. Trainer The trainer is Tony Buon, the Managing Partner of Buon Consultancy. He is a qualified workplace psychologist with over 30 years experience . Tony has worked in over 40 countries. He is a Certified Employee Assistance Professional (CEAP) and Associate Lecturer at the Aberdeen Business School. He holds degrees in Psychology, Behavioural Sciences and Work‐ place Education and trains throughout the UK, Europe, The Middle East & Asia. Tony has worked with some of the world’s leading companies over the past 30 years including; Diageo, Dolphin Energy, DuPont, Gulf Offshore, Halliburton, Hewlett‐Packard, ICI, ING Group, Kuwait Petroleum, Lend Lease, McDonalds, National Australia Bank, PetroChina, Pfizer, Qatar Petroleum, Royal Bank of Scotland, Shell, 3M, Coca Cola and Microsoft. He was also the senior consultant to the Sydney 2000 Olympic Games. Tony has also been interviewed in publications as diverse as Rolling Stone and the Reader’s Digest. He has appeared on CNN, BBC, Trans‐World Sport and many international television and radio stations. The Course The world of business has no borders. Nationalisation, globalisation and the growth of multi‐national corporations introduces challenges which managers and leaders must address. Effective cross‐cultural management and leadership demand an understanding of the complexities of culture from structural, political, social and psychological perspectives. The aims of the course are to explore the meaning and psychology of culture; to understand the impact of culture on management and leadership; to identify the areas in which cultural differences present a challenge in managing and leading employees in a multicultural environment; and finally to become more self ‐aware in cultural understanding, individual biases and assumptions and to understand the implications these have on our work. A vital course for any manager or leader work‐ ing in a multi‐cultural environment Covers the managerial, social and psychological aspects of culture Develop your cross‐cultural leadership & management skills in a fun and informative environment Discover best‐practice in diversity management and cross‐cultural communication Appreciate current business issues related to managing and leading in a cross‐cultural environment Comments from previous participants: “ ...one of the best courses I have ever attended!”“ I can’t believe how much I learnt. As an experienced expat, I thought I knew it all, this course truly expanded my people management skills”“ “...the trainer was excellent and the individual feedback and advice fantastic”“ This course will make me a better HR Manager, I have new skills I can use every day in dealing with all staff globally”   This course can be conducted on-site at your location for groups of up to 15 participants The Objectives By the end of the course, the delegates will be able to: Illustrate examples of stereotypes and stereotyping Formulate a business case for cultural diversity in their workplace List Hofstede’s five value dimensions Explain in his/her own words the meaning of each of the five value dimensions Evaluate the risks involved in international assignments The Delegates All supervisors, middle managers , department heads and senior managers Human resource personnel including HR Business Partners All staff interested in developing cross‐cultural skills The Benefits Appreciate the importance and meaning of culture Learn about the psychology of culture Develop your cross‐cultural leadership & management skills Discover how to manage and lead diverse employees in a multi‐cultural environment Appreciate current issues in international business related to managing people The Course Day 1: The Meaning and Psychology of Culture Our world today ‐ the importance of demographics Dimensions of culture Hofstede’s five value dimensions Workplace and organisational culture Stereotypes and stereotyping Cross‐cultural communication Body‐language and culture Day 2: Managing and Leading Diverse Employees Developing a global mindset Culture and strategy Managing in multi‐national companies Multi‐cultural teams and teamwork International assignments and global career development Culture shock and global working Culture and decision‐making

Level 6 NVQ Diploma in Construction Site Management

Designed for professional B2B salespeople to develop a modern approach to winning business

Designed for professional B2B salespeople to develop a modern approach to winning business