331 Organisation courses in Cambourne

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

OVERVIEW -------------------------------------------------------------------------------- This course is incredibly elegant to feed psychological feature feeling and confidence needed in an everyday work state of affairs so as to run the team and organisation to attain sensible results. it'll facilitate building your trust and loyalty and enhance your skills and your behaviour additionally it'll facilitate setting objectives, motivating and communicating together with your folks.

COURSE INFORMATION This course aims to empower you with the expertise to proficiently navigate process mapping and master the art of crafting Standard Operating Procedures (SOPs) within regulated environments. Whether you're engaged in activities that demand process improvement, continual enhancement, or SOP creation, this course offers invaluable insights tailored to your needs. It caters to individuals tasked with managing, documenting, and implementing processes and SOPs, irrespective of prior experience or skills. Our curriculum does not focus on specific software or approaches, focusing instead on fundamental principles and adaptable concepts applicable across diverse organisational landscapes. BENEFITS INCLUDE: * Hands-on experience in mapping processes * An understanding of how process maps can be used to define, communicate and continually improve complex processes * An understanding of best practice for SOPs using of process maps/process flow diagrams and process mind maps to complement text * An insight into the preparation of concise and user friendly SOPs. THIS COURSE IS STRUCTURED TO ENCOURAGE DELEGATES TO:  * Discuss and develop ideas * Develop a practical approach for creating process maps and writing SOPs * Understand how to use process maps in SOPs effectively * Discuss how process mapping for preparing SOPs can be applied to process improvement for SOPs. IS THIS COURSE FOR YOU? The course is designed for all those with responsibility for managing, documenting and implementing processes and SOPs. It assumes no prior experience or skills. The course does not recommend any specific software or approach, but explores the principles and ideas that can be applied in any organisation. WHAT WILL YOU LEARN? * Hands-on experience in mapping processes * An understanding of how process maps can be used to define, communicate and continually improve complex processes * An understanding of best practice for SOPs using of process maps/process flow diagrams and process mind maps to complement text * An insight into the preparation of concise and user friendly SOPs. By the end of the course you will be able to: * Create process maps and write clearer more concise SOPs * Understand how to use process maps in SOPs effectively * Understand how process mapping can be applied to process improvement and better SOPs. -------------------------------------------------------------------------------- TUTORS Tutors will be comprised of (click the photos for biographies): LAURA BROWN Director, Laura Brown Training and Development DAVID BUTLER VP of Quality, Resolian -------------------------------------------------------------------------------- PROGRAMME Please note timings may be subject to alteration. DAY 1 09:00 WELCOME, INTRODUCTIONS AND COURSE OBJECTIVES Why Companies manage by process. 10:00 EXERCISE 1 - FIRST STEPS Mechanisms for process mapping, levels at which it can be applied, and the roles and responsibilities of process owners. 10:30 EXERCISE 1 - FEEDBACK 10:45 BREAK 11:00 MAPPING PROCESSES The stages involved in mapping processes including how to construct a SIPOC chart. 11:45 EXERCISE 2 - MAPPING A PROCESS A first opportunity to practice your new process mapping skills. 12:30 EXERCISE 2 - FEEDBACK 13:00 LUNCH 14:00 EXERCISE 3 - DISCUSSION OF OPTIONS FOR FORMAT, STRUCTURE AND LAYOUT What Makes A Good SOP? Discussion of options for format, structure, level of detail of SOPs and the use of process maps for SOP writing. A case study example of a good SOP which uses a flow chart/process map. 14:45 EXERCISE 3 - FEEDBACK 15:00 BREAK 15:15 A CASE STUDY EXAMPLE OF A GOOD SOP THAT USES A FLOW CHART / PROCESS MAP 15:30 EXERCISE 4 Discussion of the content of an SOP using a Process Map 15:35 EXERCISE 4 - FEEDBACK 15:45 KEY WRITING CONSIDERATIONS 16:15 EXERCISE 5 16:45 EXERCISE 5 - FEEDBACK 17:00 CLOSE OF DAY DAY 2 09:00 REVIEW OF DAY 1 09:15 USING METRICS Selecting and using metrics to monitor and improve processes. 10:00 EXERCISE 6 - PRACTICE IN PROCESS MAPPING Creating Process Maps from multi-source information. 11:00 BREAK 11:15 EXERCISE 6 - FEEDBACK 11:45 COMMON PITFALLS Common problems and tips for good Process Mapping. 12:15 DEMONSTRATION OF PROCESS MAPPING ON A PC 12:45 LUNCH 13:30 EXERCISE 7 - MIND MAPPING 14:30 EXERCISE 7 - FEEDBACK 15:00 BREAK 15:15 EXERCISE 8 - USING PROCESS MAPS TO WRITE AN SOP Applying your process mapping skills as part of writing an SOP 15:30 EXERCISE 8 - FEEDBACK 15:45 COURSE REVIEW AND FOLLOW-UP 16:00 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.   DEVELOPMENT LEVEL Learn

OVERVIEW -------------------------------------------------------------------------------- Extending business activities beyond organisational boundaries to create value for the organisation is not new. However, the quantity and complexity of the relationships that now exist beyond organisational boundaries are increasing, as is regulatory and stakeholder scrutiny. While partnerships with third parties, including critical suppliers, can be beneficial to the organisation on so many levels, such alliances can expose the organisation to many unknowns, and those unknowns will undoubtedly increase the level of risk. The key, then, is properly managing the infrastructure, systems, staff and outside support to adequately manage that risk. 

Every organisation needs leaders who can think and act strategically. This program will help you clarify: Why you exist (strategic purpose) Where you are now (strategic assessment) Where you want to go (strategic development) How to get there (strategic execution)

OVERVIEW -------------------------------------------------------------------------------- Strategic planning enables an organisation to shape and guide its overall business objectives. Effective planning allows an organisation to create a framework for developing, adapting and aligning organisational vision and goals to achieve sustained competitive advantage or efficiency.

OVERVIEW -------------------------------------------------------------------------------- Performance management is a continuous process which involves making sure the performance of your employees contributes to organisational and team goals. Having effective employment management in place helps everyone in the organisation to know what the business is trying to achieve, the skill and competencies they need to fulfil their role and how they can develop their performance to develop the organisation.

OVERVIEW -------------------------------------------------------------------------------- A specialised and effectual Human Resources function is an important part of an organisation, providing the resources for a productive workforce. In this competitive world to provide the right resources to the organisation, HR Professionals need to enhance their skills to understand the effective way of recruitment.

OVERVIEW -------------------------------------------------------------------------------- The course introduces the participants to the importance of personnel in any organisation, and the systematic processes of handling personnel to bring out the best in them in order to achieve the objectives of the organisation is the responsibility of the holder of this certificate. The course curriculum covers human resource planning; recruitment and selection; employee training and development; employee health and safety etc. 

OVERVIEW -------------------------------------------------------------------------------- Advance Strategic Procurement is designed to understand the process that continuously enhances and evaluates purchasing activities of an organisation. The participant will have in-depth knowledge of procurement functions within the organisation and will also gain a deeper knowledge of advanced supply chain concepts.  Through this course, you will attain the knowledge of how to increase strategic roles and new methods and techniques of procurement performance measurements. It will also highlight the government's role and its importance in procurement in order to develop sustainable procurement.