This one day masterclass is designed to provide a practical application of the content that is covered within The DEI Playbook and is aimed at anyone tasked with launching and implementing diversity and inclusion within their organisation.
Blue CSCS Card NVQ Level 2 Craft This qualification provides you with the opportunity to showcase their knowledge, skills and understanding in their chosen craft. You will have the relevant experience in one of the trade specific areas. You will work in one of the following areas: Trowel Occupations (Bricklayer) Painting and Decorating Wall and Floor Tiling Stone Masonry Site Carpentry Plastering Roofing Induction - As soon as you register you will be given a dedicated assessor. They will arrange an induction and together with your assessor, you will get to decide on the pathway which best proves your competency. The induction is used to plan out how you will gather the relevant evidence to complete the course. During the course - The assessor will work with you to build a portfolio of evidence that allows you to showcase your knowledge, skills and experience. The assessor will also regularly review and provide you with feedback. This will allow you to keep on track to progress quickly. You will be assessed through various methods such as observations, written questions, evidence generated from the workplace, professional discussion, and witness testimonials. On completion - Once all feedback has been agreed, the Internal Quality Assurer will review your portfolio and in agreement with your assessor the certificate will be applied for.
Blue CSCS Card Level 2 NVQ Diploma in Construction Operations and Civil Engineering Services - Highways Maintenance Induction - As soon as you register you will be given a dedicated assessor. They will arrange an induction and together with your assessor, you will get to decide on the pathway which best proves your competency. The induction is used to plan out how you will gather the relevant evidence to complete the course. During the course - The assessor will work with you to build a portfolio of evidence that allows you to showcase your knowledge, skills and experience. The assessor will also regularly review and provide you with feedback. This will allow you to keep on track to progress quickly. You will be assessed through various methods such as observations, written questions, evidence generated from the workplace, professional discussion, and witness testimonials. On completion - Once all feedback has been agreed, the Internal Quality Assurer will review your portfolio and in agreement with your assessor the certificate will be applied for. To download our PDF for this course then please click here.
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
Developing Leadership and Emotional Intelligence Skills course is designed to empower participants with the essential leadership competencies and emotional intelligence skills needed to excel in today's dynamic workplace. Through a blend of theoretical frameworks, interactive exercises, and practical applications, this course aims to enhance participants' self-awareness, interpersonal relationships, and leadership capabilities, ultimately enabling them to inspire and motivate others towards achieving organizational goals.
Mentoring skills refer to the abilities needed to guide someone’s personal or professional development. Mentorship skills include active listening, providing constructive feedback, and offering guidance. Mentoring skills help individuals develop their professional skills and achieve their goals. They create the right environment for growth such as fostering safety and trust. Effective mentors provide guidance, support, and feedback to their mentees. This helps mentees navigate challenges and make progress in their careers
Blue CSCS Card NVQ Level 2 Specialist This qualification provides you with the opportunity to showcase their knowledge, skills and understanding in their chosen specialism. You will have the relevant experience in one of the specific areas. You will work in one of the following areas: Formwork Insulation and Building Treatments Steelfixing Occupations Highways Maintenance Construction Operations Steel Erecting Induction - As soon as you register you will be given a dedicated assessor. They will arrange an induction and together with your assessor, you will get to decide on the pathway which best proves your competency. The induction is used to plan out how you will gather the relevant evidence to complete the course. During the course - The assessor will work with you to build a portfolio of evidence that allows you to showcase your knowledge, skills and experience. The assessor will also regularly review and provide you with feedback. This will allow you to keep on track to progress quickly. You will be assessed through various methods such as observations, written questions, evidence generated from the workplace, professional discussion, and witness testimonials. On completion - Once all feedback has been agreed, the Internal Quality Assurer will review your portfolio and in agreement with your assessor the certificate will be applied for. To download our PDF for this course then please click here.
Blue CSCS Card NVQ Level 2 Specialist This qualification provides you with the opportunity to showcase their knowledge, skills and understanding in their chosen specialism. You will have the relevant experience in one of the specific areas. You will work in one of the following areas: Formwork Insulation and Building Treatments Steelfixing Occupations Highways Maintenance Construction Operations Steel Erecting Induction - As soon as you register you will be given a dedicated assessor. They will arrange an induction and together with your assessor, you will get to decide on the pathway which best proves your competency. The induction is used to plan out how you will gather the relevant evidence to complete the course. During the course - The assessor will work with you to build a portfolio of evidence that allows you to showcase your knowledge, skills and experience. The assessor will also regularly review and provide you with feedback. This will allow you to keep on track to progress quickly. You will be assessed through various methods such as observations, written questions, evidence generated from the workplace, professional discussion, and witness testimonials. On completion - Once all feedback has been agreed, the Internal Quality Assurer will review your portfolio and in agreement with your assessor the certificate will be applied for. To download our PDF for this course then please here.
This one-day course introduces the field of user experience and provides an excellent entry point to our other specialised training courses. UX processes and practices have become a central component of product design, service design and web design.