343 Courses

The Real Estate Investor course primarily focuses on financial modelling and commercial considerations in the real estate industry across various sectors, geographies, and project types.

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

Course Information Join our comprehensive course, meticulously designed to equip individuals implementing Good Clinical Laboratory Practice (GCLP) within laboratories handling samples from clinical trials. Delve into the current regulatory landscape governing laboratory work supporting clinical trials, referencing key guidelines such as the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive, relevant regulations, and leveraging insights from the RQA guidance document on GCLP. Is this course for you? This course is tailored for laboratory managers, analysts, investigators, trial coordinators, monitors, and auditors operating in diverse settings such as pharmaceutical company laboratories, central laboratories, contract research organisations, hospital laboratories, clinics, and investigator sites. This course will give you: Guidance on effectively interpreting and applying GCLP within the broader framework of Good Clinical Practice (GCP) Insight into the seamless integration of GCLP within clinical programmes (GCP) Practical strategies for implementing GCLP in the nuanced environment of clinical research laboratories The chance to update your knowledge with the latest interpretations and guidance on clinical laboratories by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) Access to a seasoned panel of speakers with extensive expertise A unique opportunity to deepen your understanding of GCLP's application across diverse scenarios. Engage in: Lively discussions to foster ideas Problem-solving sessions targeting specific challenges Detailed exploration of specific aspects within the realms of GCP and GCLP. Tutors Tutors will be comprised of (click the photos for biographies): Vanessa Grant -, - Louise Handy Director, Handy Consulting Ltd Tim Stiles Consultant, Qualogy Ltd Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introduction 09:20 Good Clinical Practice and the Requirements of Good Clinical Laboratory Practice A review of Good Clinical Practice and its requirements for the laboratory analysis of samples from a trial. The thought processes behind the development of Good Clinical Laboratory Practice, its objective, scope, interpretation and application are explained. 10:00 Safety and Ethical Consideration Informed consent, confidentiality, expedited reporting, blinding and unblinding and serious breaches of the GCP are discussed. 10:40 Break 10:55 Organisation and Personnel Responsibilities within GCP and the Laboratory The responsibilities of key functions that should exist within a clinical laboratory including personnel records of training and competence are discussed. 11:30 Staff Training and Training Records Personnel records of training and competency assessments are discussed. 11:45 Laboratory Facilities, Equipment and Materials Suitable facility design, organisation and operation will be discussed. The calibration, validation and maintenance of equipment used in the conduct of sample analysis are examined, as are the suitability of materials and the identification and labelling of reagents and solutions. 12:30 Lunch 13:15 Workshop 1 - Facilities, Equipment and Responsibilities Some practical problems with regard to the facilities, equipment and responsibilities are explored. 13:45 Workshop 1 - Feedback 14:15 Computer Systems Validation Systems, including computerised systems, used in the analysis, collection and reporting of results should be appropriately tested, operated and controlled. What this means in practice is discussed. 14:45 Trial Protocols, Analytical Plans During this session we examine the purpose, content, control and change of these important documents. 15:30 Break 15:45 Workshop 2 - SOPs, Clinical Protocols, Analytical Plans and Validation The practicalities of managing and documenting the planning phase of analytical work on a trial are explored along with computerised system validation. 16:30 Workshop 2 - Feedback 17:00 Close of Day Day 2 09:00 Conduct of the Work and Quality Control Many of the issues that surround the conduct of sample collection, shipment, storage, analysis and management of Analytical Methods are discussed. This includes the quality control of the assay that may be employed and Quality Control checks. 10:00 Deviation Management The expectations around deviations and CAPA are discussed. 10:15 Workshop 3 - Conduct of the Work and Quality Control Practical work conduct and quality control issues are explored. 10:45 Break 11:00 Workshop 3 - Feedback 11:30 Source Data, Data Integrity, Records and Reports The creation and subsequent management of source data and records, data integrity, are discussed, together with the process of reporting analytical results. 12:10 Workshop 4 - Data, Records and Reports Practical problems with data, records and reports are investigated. 12:45 Lunch 13:30 Workshop 4 - Feedback 14:00 Quality Audit The requirements for and purpose of quality audits are discussed. The difference between quality audit and quality control are explained along with the role of the quality audit staff and their interaction with the analytical project managers, laboratory management and study staff. 14:40 Risk Management How should we assess risk and how can we use the process to assist in evaluation of audit findings. 15:15 Break 15:30 Regulatory Inspection The conduct of regulatory inspections and current expectations of the inspectors. Preparation for inspections and conduct during them will be discussed. 16:00 Panel Session This panel session will address any outstanding issues raised by the delegates. 16:15 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. 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. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote 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 14 Points Development Level Develop

PgMP® Exam Prep This course is designed and developed by PgMP® certified consultants and instructors. Its aim is to prepare professionals who are familiar with the principles of program management for the Program Management Professional (PgMP)® Examination. The course is based on PMI's The Standard for Program Management, A Guide to the Project Management Body of Knowledge (PMBOK® Guide), and PMI's Program Management Professional (PgMP)® Examination Content Outline (current versions). Through this learning experience, you will explore: Program management from a PMI standard perspective, including the interdependencies between the five performance domains, the three program phases, and the ten supporting activities in this new and improved program management standard The difference between the five performance domains in the new program management standard and the five practice domains in the examination content outline The role and competencies of the program manager The difference between project managers and program managers - and their relationship in a program environment The difference between program managers and portfolio managers - and their relationship in a program environment How program managers align and manage benefits The best ways to engage and involve program stakeholder groups How to establish governance across the program life cycle What You Will Learn At the end of this course, you will be able to: Differentiate between the practice domains in the PMI PgMP® Examination Content Outline and the performance domains in The Standard for Program Management - Fourth Edition Name and describe the three phases in the program management life-cycle phases Describe the mapping of the life-cycle phases with the supporting program activities Identify the key outputs of the supporting program activities Articulate the interrelationships between the program management supporting processes and the mapping of processes to Knowledge Areas and Process Groups in the PMBOK® Guide - Sixth Edition Apply program management knowledge to answer foundation and scenario-based questions Summarize the process and eligibility criteria for earning the PgMP® credential Getting Started Introductions Course structure Course goals and objectives Foundation Concepts Programs, projects, and portfolio definitions differences, and how they relate The definition of a component and how it relates to a program Representative program management life cycle Role of the program manager and the program office The difference between the program management practice and performance domains Program Register and Knowledge Asset Management Program registers, and how they are used to manage knowledge assets Knowledge asset management, beginning with the data, information, knowledge, and wisdom (DIKW) Model Knowledge assets and relationship to the performance domains The program manager as a knowledge asset manager Types of Programs Perspectives on programs to establish the 'right' perspective Categories of programs based on the program standard Scenario-based questions Program and Organization Strategy Alignment An overview of the Program Strategy Alignment performance domain Exploration of the elements of strategic alignment, i.e., the business case, program charter, and program roadmap Exploration of organization maturity and strategic alignment Scenario-based questions that reference both the Program Strategy Alignment performance domain and the Strategic Program Management practice domain Program Benefits An overview of the Program Benefits Management performance domain Exploration of each benefits management interaction with the representative program management life cycle: Benefits IdentificationBenefits Analysis and PlanningBenefits DeliveryBenefits TransitionBenefits SustainmentScenario-based questions that reference both the Program BenefitsManagement performance domain and the Benefits Management practice domain Program Stakeholder Engagement An overview of the Program Stakeholder Engagement performance domain Exploration of each stakeholder engagement performance domain activity: Program Stakeholder IdentificationProgram Stakeholder AnalysisProgram Stakeholder Engagement PlanningProgram Stakeholder EngagementProgram Stakeholder CommunicationsScenario-based questions that reference both the Program StakeholderEngagement performance domain and the Stakeholder Management practice domain Program Governance An overview of the Program Governance performance domain Exploration of each program governance performance domain activity: Program governance practicesProgram governance roles and responsibilitiesProgram governance design and implementationGovernance relationship within programsScenario-based questions that reference both the Program Governance performance domain and the Governance practice domain Program Life Cycle Management An overview of the Program Life Cycle Management performance domain Exploration of the three phases in the representative program life cycle: Program DefinitionProgram DeliveryProgram ClosureExploration of the interaction between program activities and integration managementScenario-based questions that reference both the Program Life CycleManagement performance domain and the Program Life Cycle practice domain Program Management Supporting Activities - Part 1 An overview of the program management supporting activities Exploration of 5 of 10 supporting activities: Program change managementProgram communications managementProgram financial managementProgram information managementProgram procurement managementScenario-based question(s) presented after each supporting activity Program Management Supporting Activities - Part 2 Exploration of the remaining 6 of 10 supporting activities: Program quality managementProgram resource managementProgram risk managementProgram schedule managementProgram scope managementScenario-based question(s) presented after each supporting activity Program Management Professional (PgMP®) Examination Application process and timeline General and special eligibility criteria International Institute's Online Learning Tool - access to sample examination questions Program Management Professional (PgMP®) Examination breakdown of domains and subdomains Terms and conditions of the exam PgMP® Professional Code of Conduct

Gain expertise in process safety management engineering through EnergyEdge's course. Participate in our classroom training to enhance your skills and knowledge.

Health & Safety in Equipment Hire - incorporating Workshop H&S Essentials

The Temporary Works Supervisor course will provide you with knowledge of the role. You will also gain a good understanding of risk management on a temporary works site. Course Objectives: By the end of the course, the delegate will gain knowledge of: Have gained an understanding of the importance of cooperation and teamwork on a temporary works site Understand the legal duties of the role Have a stronger awareness of risk management on-site as well as the roles of a supervisor and their fellow employees on site Leave the course with an understanding of the “4C’s”, Communication, Cooperation, Coordination and Competency Course Content: Different groups and types of Temporary Works BS5975:2019 CDM Regulations Legislation and Codes of Practice Temporary Works Register, Design Brief and Design Case studies, policy and procedures, Standard solutions and permitted drawings Risk assessments, method statements Safe systems of work The roles and duties of a Temporary Works Supervisor Assessment: To successfully complete the course, you will need to get 72% or above in the final exam. The trainer encourages the delegates to be interactive and involved throughout the training. Certificate: The certificate for this course is valid for 5 years. Instructions Please note all Temporary Works Supervisor courses with the venue “Remote Learning” will be delivered by a tutor over a video call. This training will be delivered and assessed in English language; therefore, a good standard is required to complete the course. Further attendee information will be sent in a separate email, please check your inbox.

This course concentrates on the legal requirements for risk assessments in the organisation and...

This highly-regarded course gives team leaders, supervisors and managers, the training they need...

The Temporary Works Coordinator course will provide you with knowledge of the role. You will also gain a good understanding of risk management on a temporary works site. Course Objectives: By the end of the course, the delegate will gain knowledge of: The need for a temporary works co-ordinator The day-to-day roles of others involved in the temporary works procedures Risk assessments and method statements Best procedures as stated in BS 5975:2019 Course Content: The content covered by the CITB course includes: Various groups and types of Temporary Works Case studies, procedures and policies of Temporary Works BS5975:2019 CDM Regulations Legislation and relevant Codes of Practice Register for Temporary Works, design requirements and checks Standard solutions and guidance design documents Temporary works Co-ordinator – job role and responsibilities Assessment: To successfully complete the course, you will need to get 72% or above in the final exam. The trainer encourages the delegates to be interactive and involved throughout the training. Certificate: The certificate for this course is valid for 5 years. Instructions Please note all Temporary Works Coordinator courses with the venue “Remote Learning” will be delivered by a tutor over a video call. This training will be delivered and assessed in English language; therefore, a good standard is required to complete the course. Further attendee information will be sent in a separate email, please check your inbox.