3 QLS Endorsed Diploma | QLS Hard Copy Certificate Included | 10 CPD Courses | Lifetime Access | 24/7 Tutor Support
3 QLS Endorsed Diploma | QLS Hard Copy Certificate Included | 10 CPD Courses | Lifetime Access | 24/7 Tutor Support
3 QLS Endorsed Diploma | QLS Hard Copy Certificate Included | Plus 10 CPD Courses | Lifetime Access
3 QLS Endorsed Diploma | QLS Hard Copy Certificate Included | 10 CPD Courses | Lifetime Access | 24/7 Tutor Support
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
In today's dynamic visual landscape, photography stands as both an art form and a crucial means of communication. As the demand for captivating images continues to soar, there's a growing need for skilled photographers who can navigate diverse genres. In the UK, where visual storytelling is at its peak, mastering the intricacies of digital, fashion, product, outdoor, and street photography is paramount. Our comprehensive CPD Certified course caters to this demand, offering an immersive journey through the lens, from the basics of digital photography to advanced techniques like aerial imaging and astrophotography. This Photography: Digital, Fashion, Product, Outdoor & Street Photography - CPD Certified Bundle Consists of the following Premium courses: Course 01: Photography : Digital Photography Course 02: Portrait Photography Masterclass Course 03: Outdoor Photography Course 04: Flash Photography: Off-Camera Flash Course 05: Product Photography Course 06: Creating 360º Photos with Photoshop Course 07: Smartphone Photography Online Course Course 08: Event Management & Wedding Photography Course 09: Night Photography Course Course 10: Family Portrait Photography Masterclass Course 11: Stage Lighting Course 12: Basic Food Photography Course 13: Drone Photography: Aerial Imaging and Cinematography Course 14: Fashion Photography: Capturing Style and Elegance Course 15: Adobe Lightroom CC Course 16: Mastering the Art and Science of Astrophotography Course 17: Professional After Effect for Photography Course 18: Adobe Photoshop CC Course 19: Digital Art - Sketching In Photoshop for Beginners Course 20: Digital Painting Course 10 Extraordinary Career Oriented courses that will assist you in reimagining your thriving techniques- Course 01: Effective Communication Skills Diploma Course 02: Business Networking Skills Course 03: Influencing and Negotiation Skills Course 04: Delegation Skills Training Course 05: Time Management Course 06: Leadership Skills Training Course 07: Decision Making and Critical Thinking Online Course Course 08: Emotional Intelligence and Social Management Diploma Course 09: Assertiveness Skills Course 10: Touch Typing Complete Training Diploma Learning Outcomes: Upon completion of this Photography: Digital, Fashion, Product, Outdoor & Street Photography - CPD Certified bundle, you should be able to: Capture stunning portraits with advanced techniques and styles. Excel in outdoor photography, leveraging natural light and landscapes. Master off-camera flash for impactful and dynamic images. Showcase products with finesse through expert product photography. Navigate the realms of smartphone and night photography adeptly. Elevate your skills in astrophotography and aerial imaging. This course is designed to empower aspiring photographers with a versatile skill set, addressing contemporary challenges and trends. Unveil the secrets of outdoor photography, conquer the intricacies of flash photography, and delve into the realms of product and fashion photography. From mastering Adobe Lightroom and Photoshop to the intricacies of 360º and drone photography, this course equips you with the tools to transform your vision into captivating imagery. Join us on a transformative odyssey that transcends conventional photography boundaries, embracing both the timeless and the cutting-edge. CPD 300 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Enthusiasts seeking to master diverse photography genres. Content creators aiming to enhance their visual storytelling. Individuals keen on exploring the creative potential of photography. Professionals desiring to broaden their skill set in imaging. Hobbyists aspiring to turn their passion into a refined craft. Please Note: Studyhub is a Compliance Central approved resale partner for Quality Licence Scheme Endorsed courses. Requirements To participate in this Photography course, all you need is - A smart device A secure internet connection And a keen interest in Photography Career path Portrait Photographer: •25,000 - •35,000 Product Photographer: •28,000 - •40,000 Wedding Photographer: •22,000 - •30,000 Fashion Photographer: •28,000 - •45,000 Event Photographer: •20,000 - •28,000 Aerial Photographer: •30,000 - •45,000 Certificates CPD Accredited Certificate Digital certificate - Included CPD Accredited e-Certificate - Free CPD Accredited Hardcopy Certificate - Free Enrolment Letter - Free Student ID Card - Free
FREE Level 7 QLS Hard Copy Certificate | 10 CPD Courses & PDF Certificates | 180 CPD Points | Tutor Support
Are you prepared to start the thrilling path to becoming a highly competent manager? With our Level 5 Diploma in Manager Management, you'll gain a comprehensive understanding of the essential skills and knowledge required to lead and manage teams effectively in today's dynamic business environment. This rigorous program will equip you with the expertise to navigate the complexities of project management, human resources, communication, and strategic planning. This course will help you master the essential skills of Manager Management, such as Global Project Management, Quality Management, Human Resources, and more. You will learn how to plan and schedule your projects effectively, measure and improve your performance, and manage your talent. You will also develop your abilities in Conflict Management, Stress Management, and Communication Skills, which are crucial for creating a positive work culture. Additionally, you will gain insights into Procurement & Purchasing and Risk Management, which are key aspects of managing resources and uncertainties. This course is your gateway to comprehensive insights into Managerial roles. It positions you as a strategic leader capable of navigating challenges with finesse. Enrich your professional profile with an in-depth understanding of Manager Management, setting you apart in today's competitive job market. Learning Outcomes: Develop advanced proficiency in Project Management principles. Master the art of effective Time and Quality Management. Hone your skills in Human Resources, Performance, and Talent Management. Acquire expertise in Conflict, Stress, and Crisis Management. Enhance communication skills crucial for effective leadership. Navigate Procurement & Purchasing and Risk Management with confidence. Level 5 Diploma in Manager Management Module 01: Introduction to Project Management Module 02: PMBOK and PMI Module 03: Global Project Management Module 04: Project Life Cycle Module 05: Time Management Module 06: Quality Management Module 07: Effective Planning & Scheduling Module 08: Human Resources Module 09: Performance Management Module 10: Talent Management Module 11: Organising Meetings and Conferences Module 12: Managing Resources Module 13: Change Management Module 14: Business Resilience and Crisis Management Module 15: Conflict Management Module 16: Stress Management Module 17: Communication Skills Module 18: Procurement & Purchasing Module 19: Risk Management Certificate of Achievement Endorsed Certificate of Achievement from the Quality Licence Scheme Learners will be able to achieve an endorsed certificate after completing the course as proof of their achievement. You can order the endorsed certificate for Free to be delivered to your home by post. For international students, there is an additional postage charge of £10. Endorsement The Quality Licence Scheme (QLS) has endorsed this course for its high-quality, non-regulated provision and training programmes. The QLS is a UK-based organisation that sets standards for non-regulated training and learning. This endorsement means that the course has been reviewed and approved by the QLS and meets the highest quality standards. Who is this course for? This course is suitable for: Project Manager Operations Manager Team Lead Quality Assurance Manager Human Resources Manager Crisis Management Specialist Requirements Level 5 Diploma in Manager Management To enrol in this course, all you need is a basic understanding of the English Language and an internet connection. Career path Level 5 Diploma in Manager Management Operations Manager: £40,000 to £70,000 per year Project Manager: £35,000 to £60,000 per year Human Resources Manager: £40,000 to £70,000 per year Sales Manager: £40,000 to £60,000 per year Supply Chain Manager: £40,000 to £70,000 per year Business Development Manager: £40,000 to £65,000 per year Certificates CPD Accredited PDF Certificate Digital certificate - Included QLS Endorsed Hard Copy Certificate Hard copy certificate - Included CPD Accredited Hard Copy Certificate Hard copy certificate - £9.99 CPD Accredited Hard Copy Certificate Delivery Charge: Inside the UK: Free Outside of the UK: £9.99 each
10 QLS Endorsed Courses for Teacher | 10 Endorsed Certificates Included | Life Time Access
Level 3 QLS Endorsed Course | Endorsed Certificate Included | Plus 5 Career Guided Courses | CPD Accredited