10669 Professional Development courses in Tring delivered On Demand

This module provides a guide to signal detection and management for approved products. The subject is presented as a process comprising four stages: signal detection, signal validation, signal analysis and prioritisation, and risk assessment and minimisation.

Medicines for the prevention, diagnosis, or treatment of rare diseases have become known as ‘orphan drugs’ because of their commercial unattractiveness. Development of such products is successfully encouraged through incentives offered by regulatory authorities. To qualify for important incentives, the sponsor of a drug must gain ‘orphan designation’ for its use in an indication. This module describes the requirements for orphan designation and how to apply for it in the USA and the European Economic Area.

The Centralised Procedure (CP) is one of three routes available to applicants to gain multinational marketing authorisation within the European Economic Area (EEA) on the basis of a single application. In the CP, one successful application leads to a marketing authorisation being issued by the European Commission that applies throughout the EEA. The CP is mandatory for certain types of products.

This module addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biological medicinal products such as those based on mAbs differ in certain respects from those for small-molecule products. This is because of the distinct characteristics of biologics, such as complex structure and susceptibility to variation during manufacture.

The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, typically hospitals, has to be evaluated, and the trial has to be set up at each site. This module describes the processes involved, focusing particularly on the role of a Clinical Research Associate (CRA) employed or contracted by the sponsor to monitor the trial.

This module provides an understanding of how clinical trials fit into the drug development process. It outlines the key historical events leading to the development of controlled clinical trials. It specifies the purpose of trials, outlines their features, and identifies codes and regulations that apply to them. Finally, it describes the environment of cost control in which the modern pharmaceutical industry operates.

Good Manufacturing Practice (GMP) is a set of rules for medicines manufacturers to follow so that their products are safe, effective, and of good quality. The rules may be written into law or set out in guidance documents from regulatory authorities. Regulators will not allow medicinal products to be placed, or to remain, on the market in their country unless the products can be shown to be manufactured in compliance with GMP. To this end, they carry out inspections of manufacturing plants. Companies that persistently commit serious breaches of GMP requirements have suffered huge fines.

The warehouse plays a crucial role in a medicinal products factory. This module explains the requirements of Good Manufacturing Practice (GMP) for the warehouse, and how to comply with them.

Pharmacokinetic (PK) and pharmacodynamic (PD) studies provide a bridge between science and medicine in the development of a drug. In this module we describe the role of in-vivo PK and PD studies in a drug development programme, set out the uses to which the findings can be put, and discuss their implications for clinical development and application for marketing approval.

Overview The Level 3 Certificate in Assessing Vocational Achievement (RQF) is intended to help you acquire an RQF Assessing Vocational Achievement certificate. You will learn the principles and practices that support assessment, which will be shown by a written account proving your knowledge and comprehension, as well as the completion of a workbook that demonstrates research into assessment practice and associated legal requirements. You will also have the ability to conduct performance evaluations in an individual's work setting. You'll also learn how to evaluate your performance in terms of occupational skills, knowledge, and understanding in settings other than the workplace. This might take place in workshops, classrooms, or other training settings. So buckle up and sign up now! Benefits you will gain: Top-notch e-learning materials Modules availability 24/7 An easy-to-use online learning platform Flexible learning hours Level 3 Certificate in Assessing Vocational Achievement (RQF) (Regulated qualification) Exquisite customer service Qualification Focus Awards Level 3 Certificate in Assessing Vocational Achievement (RQF). Description Learners must complete all 3 mandatory units to achieve a total credit of 15In this course, you will: Understand the principles and requirements of assessment. Learn more about different types of assessment methods, manage information, make assessment decisions, and assure quality. Maintain legal and good practice requirements when assessing occupational competence. Plan the assessment of occupational competence. Be able to prepare and carry out assessments of vocational skills, knowledge and understanding. Qualification Purpose This comprehensive Level 3 Certificate in Assessing Vocational Achievement (RQF) course is designed to help students master the knowledge and skills they'll need to effectively assess occupational competence in the workplace and outside the workplace. Who is this course for? The Level 3 Certificate in Assessing Vocational Achievement (RQF) course is for individuals wanting to serve as fully qualified assessors in the educational sector. Individuals who wish to achieve a sought-after assessment certificate will benefit from its excellent training. Entry Requirements There are no specific entry requirements for this qualification. This qualification is accredited for learners who are at least 19 years old or older. Progression Learners wishing to progress from this qualification can undertake the following qualifications: Focus Awards Level 3 Award in Assessing Competence in the Work Environment Focus Awards Level 4 in Understanding the Internal Quality Assurance of Assessment Processes and Practices Focus Awards Level 4 in the Internal Quality Assurance of Assessment Processes and Practices Focus Awards Level 4 Certificate in Leading the Internal Quality Assurance of Assessment Processes and Practices Total Qualification Time Total Qualification Time consists of GLH and an estimate of the number of hours a learner is likely to spend in preparation, study or any other learning, including assessment, which takes place as directed by but not under the supervision of a lecturer, supervisor or tutor.Total Qualification Time for this qualification is 234 hours.Guided Learning HoursThese hours are made up of all contact time, guidance, or supervision of a learner by a lecturer, supervisor, tutor, trainer, or other appropriate education or training providers. Guided Learning Hours for this qualification are 84. Method of Assessment: The Level 3 Certificate in Assessing Vocational Achievement (RQF) is internally assessed and externally assured by Focus Awards. Each learner is required to create a portfolio of evidence that demonstrates the achievement of all the learning outcomes and the assessment criteria associated with each unit. The main pieces of evidence for the portfolio could include: Assessor observation - completed observational checklists on related action plans Witness testimony Learner product Worksheets Assignments / projects / reports Record of oral and written questioning Learner and peer reports Recognition of prior learning (RPL) Evidence may be drawn from actual or simulated situations where appropriate and permitted by the relevant Sector Skills Council or Sector Skills Body. Career path After receiving the Level 3 Certificate in Assessing Vocational Achievement (RQF) certification, you would be eligible to function as a competent professional as: Assessor Professional Trainer Coach Professional Verifier Course Curriculum 32 sections • 89 lectures • 00:40:00 total length •Induction Form: 00:00:00 •Registration Entry Form: 00:00:00 •Unit 1 Understanding The Principles And Practices Of Assessment Guidance For Achieving The Unit: 00:00:00 •Unit 2 Assess Occupational Competence In The Work Environment Guidance For Achieving The Unit: 00:00:00 •Unit 3 Assess Vocational Skills, Knowledge And Understanding Guidance For Achieving The Unit: 00:00:00 •Assessment Guidelines: 00:00:00 •1. Functions of Assessment in Learning and Development: 00:00:00 •2. Key Concepts and Principles of Assessment: 00:00:00 •3. Responsibilities of an Assessor: 00:00:00 •4. Regulations and Requirements Relevant to the Assessment: 00:00:00 •1. Strengths and Limitations of Various Assessment Methods: 00:00:00 •1. Key Factors to Consider When Planning Assessment: 00:00:00 •2. Benefits of Using A Holistic Approach to Assessment: 00:00:00 •3. How to Plan A Holistic Approach to Assessment: 00:00:00 •4. Types of Risks Involved in Assessment: 00:00:00 •5. How to Minimise Risks Through the Planning Process: 00:00:00 •1. Importance of Involving Learner and Others in The Assessment Process: 00:00:00 •2. Information That Should Be Made Available to Learners and Others: 00:00:00 •3. How to Use Peer and Self-Assessment Effectively: 00:00:00 •4. Assessment Arrangements to Meet the Needs of Individual Learners: 00:00:00 •1. Assessment Decisions and Judging Evidence: 00:00:00 •1. Importance of Quality Assurance in The Assessment Process: 00:00:00 •2. Quality Assurance and Standardisation Procedures: 00:00:00 •3. Appeals, Complaints & Disputes Procedures Concerning Assessment in Own Area of Practice: 00:00:00 •1. Importance of Following Procedures for The Management of Information Relating to Assessment: 00:00:00 •2. How Feedback and Questioning Contribute to the Assessment Process: 00:00:00 •1. Legal Issues, Policies and Procedures Relevant to Assessment: 00:00:00 •2. Contribution of Technology in the Assessment Process: 00:00:00 •3. Evaluation of Requirements for Equality, Diversity: 00:00:00 •4. Reflective Practice and Continual Professional Development: 00:00:00 •1. Assessment Planning of Occupational Competence: 00:00:00 •2. Communicating the Process of Assessing Occupational Competence to The Learner: 00:00:00 •3. Planning the Assessment of Occupational Competence to Address Learner Needs and Current Achievements: 00:00:00 •4. Opportunities for Holistic Assessment: 00:00:00 •1. Valid, Fair and Reliable Assessment Method: 00:00:00 •2. Making Assessment Decisions of Occupational Competence: 00:00:00 •3. Following Standardisation Procedures: 00:00:00 •4. Providing Feedback to Learners: 00:00:00 •1. Maintaining Records of the Related Information of the Assessment of Occupational Competence: 00:00:00 •2. Sharing Assessment Information with Authorised Colleagues and Procedures to Maintain the Confidentiality: 00:00:00 •1. Relevant Policies, Procedures and Legislation for the Assessment of Occupational Competence: 00:00:00 •2. Application of Requirements for Equality and Diversity and Bilingualism in Assessing Occupational Competence: 00:00:00 •3. Evaluation of Own Work in Carrying Out Assessments: 00:00:00 •4. Maintaining the Currency of Own Expertise and Competence: 00:00:00 •1. Methods of Assessing Vocational Skills, Knowledge and Understanding to Meet Requirements and Needs: 00:00:00 •2. Preparing Resources and Conditions for The Assessment: 00:00:00 •3. Communicating the Purpose, Requirements and Processes of Assessment to Learners: 00:00:00 •1. Assessment Management to Meet Assessment Requirements: 00:00:00 •2. Providing Support to Learners Within Agreed Limitations: 00:00:00 •3. Analysing Evidence of Learner Achievement: 00:00:00 •4. Making Assessment Decisions Related to Vocational Skills, Knowledge and Understanding: 00:00:00 •5. Standardisation Procedures: 00:00:00 •6. Feedback on Learners' Achievement: 00:00:00 •1. Maintaining Records of Assessment, Its Outcome and Learners Progress: 00:00:00 •2. Making Assessment Information Available to Authorised Colleagues as Required and Maintaining Confidentiality: 00:00:00 •1. Relevant Policies, Procedures and Legislation Relating to The Assessment of Vocational Skills, Knowledge and Understanding: 00:00:00 •2. Applying Requirements for Equality and Diversity and Bilingualism: 00:00:00 •3. Evaluation and CPD: 00:00:00 •Equality and Diversity - Glossary of Terms: 00:00:00 •Equality and Diversity, and The Equality Act 2010: 00:00:00 •Key Feedback Words for Use During Feedback: 00:00:00 •Table of Assessment Methods & Activities: Strengths and Limitations: 00:40:00 •Table of Assessment Types: 00:00:00 •Table of Example Assessment Records: 00:00:00 •Table of Example Assessment Requirements: 00:00:00 •Table of Objectives: 00:00:00 •Table of Potential Learner Needs and Points of Referral: 00:00:00 •Table of Resources Which Could be Used for Teaching, Learning and Assessment: 00:00:00 •Using Questions: 00:00:00 •Unit One Understanding The Principles And Practices Of Assessment - Self-Assessment Grid: 00:00:00 •Unit Two Assess Occupational Competence In The Work Environment - Self-Assessment Grid: 00:00:00 •Unit Three Assess Vocational Skills, Knowledge And Understanding - Self-Assessment Grid: 00:00:00 •Unit 1 Understanding The Principles And Practices Of Assessment Assessment Plan: 00:00:00 •Unit 2 Assess Occupational Competence In The Work Environment Assessment Plan: 00:00:00 •Unit 3 Assess Vocational Skills, Knowledge And Understanding Assessment Plan: 00:00:00 •OBSERV 1: 00:00:00 •OBSERV 2: 00:00:00 •Template - Continuing Professional Development Record: 00:00:00 •Template - Personal Development Plan: 00:00:00 •Template - Reflective Learning Journal: 00:00:00 •Template - Standardisation Record for Assessed Work: 00:00:00 •Templates - A Full Set of Assessment Records: 00:00:00 •Completed Example of A Continuing Professional Development Record: 00:00:00 •Completed Example of A Full Set Of Assessment Records: 00:00:00 •Completed Example of A Personal Development Plan: 00:00:00 •Completed Example of A Reflective Learning Journal: 00:00:00 •Completed Example of A Standardisation Record For Assessed Work: 00:00:00 •Submit Your Assignments: 00:00:00 •Resubmit Your Assignments - Level 3 Certificate in Assessing Vocational Achievement (RQF): 00:00:00