The heaviest legal penalties imposed on drug companies concern interactions with healthcare professionals in the context of prescription drug marketing, notably for violations of the Anti-Kickback Statute and the False Claims Act. Monetary penalties have amounted to billions of dollars in some cases.
In this course we explain how to advertise and promote prescription drugs in various media, whether to healthcare professionals or consumers, in compliance with legal requirements and guidance from the FDA.
This course sets out the legal and regulatory requirements for safety reporting in clinical trials of medicinal products under the jurisdictions of the European Union and the USA. It builds on the foundation laid by our companion course CT13, Safety Reporting in Clinical Trials, and provides greater detail of specific requirements in those jurisdictions.
This course explains the regulatory requirements for the reporting of adverse events and suspected adverse reactions in clinical trials. It describes how investigators should report to sponsors, and how sponsors should report to regulatory authorities and other stakeholders in the safety of investigational products. It explains how events are characterized as serious or non-serious, expected or unexpected, and it distinguishes the requirements for each category. It describes controlled vocabularies used for coding of events in reports.
This course sets out the procedures that sponsors need to follow to gain authorisation to conduct clinical trials under the Regulation, and it summarises and links to the extensive guidance available from the European Commission and the European Medicines Agency. Its companion course CT12 sets out the procedures that sponsors need to follow to conduct authorised clinical trials in compliance with the Regulation. The two courses therefore provide an ideal foundation for understanding and complying with the new law.
Advance your teaching career with our 120 Hours TEFL (TESOL) Masterclass. Gain the skills needed to teach English globally and open doors to exciting opportunities.
The BCS Practitioner Certificate in Business Analysis Practice, an advanced course honing expertise in business analysis. Master practical techniques, stakeholder engagement, and requirements engineering. About this course £396.00 110 lessons Accredited training Certificate of completion included Course curriculum IntroductionCourse Introduction Session 11.1 Learning Objectives1.2 Understanding the Strategic Context1.3 SWOT Analysis1.4 VMOST Analysis1.5 Resource Audit1.6 Porter's Five Forces1.6 PESTLE Analysis1.7 Balanced Business Scorecard(BSC)1.8 Performance Measurement and VMOST1.9 Critical Success Factors(CSF's), Key Performance Indicators(KPI's) and Targets1.10 Attributes of Good Objectives(SMART)1.11 How does it all work together?1.12 Test Your Knowledge Session 22.1 Learning Objectives2.2 Introduction2.3 What is a Stakeholder?2.4 Stakeholder Engagement and the Strategic Context2.5 Stakeholder Engagement2.6 Stakeholder Analysis2.7 The Stakeholder Wheel2.8 Power Interest Grid2.9 RACI Chart2.10 Understanding Stakeholder Perspectives2.11 Stakeholder and Business Perspectives2.12 The CATWOE Technique2.13 Root Definition2.14 Identifying Conflicts2.15 Test Your Knowledge Session 33.1 Learning Objectives3.2 Background Research3.3 Investigation Techniques3.4 Tools to Represent the Current State3.5 Test Your Knowledge Session 44.1 Learning Objectives4.2 Introduction4.3 What is a Business Activity Model?4.4 The Approach to Business Activity Modelling4.5 The Benefits of a Business Activity Model4.6 Corner Shop Example of a Business Activity Model4.7 Building the Business Activity Model4.8 Common Errors in a Business Activity Model4.9 Producing a Consensus Model4.10 Business Events4.11 Business Rules4.12 Identifying Areas of Concern4.13 Target Operating Model (TOM)4.14 Defining the New Business ModelTest Your Knowledge Session 55.1 Learning Objectives5.2 Introduction5.3 Design Thinking5.4 Divergent Thinking5.5 Gap Analysis5.6 Formulating Options5.7 Areas of FeasibilityTest Your Knowlege
The BCS Practitioner Certificate in Requirements Engineering, an advanced course unlocking the art of effective requirement's management. Gain mastery in elicitation, analysis, documentation, and validation. About this course £396.00 28 lessons Accredited training Certificate of completion included Course curriculum IntroductionIntroduction to Requirements Engineering Module 1Lesson - Define Requirements & Project ScopeTest Your Knowledge Quiz Module 2Lesson - Elicit RequirementsTest Your Knowledge Quiz Module 3Lesson - Record Requirements in DocumentationTest Your Knowledge Quiz Module 4Lesson - Build Models & Prototypes to Represent the RequirementsTest Your Knowledge - Quiz Module 5Lesson - Collaborate & Communicate with Stakeholders to Clarify RequirementsTest Your Knowledge Quiz
The BCS Practitioner Certificate in Modelling Business Processes, an advanced program focusing on business process modelling. Acquire in-depth knowledge of process mapping, analysis, and improvement techniques. About this course £396.00 18 lessons Accredited training Certificate of completion included Course curriculum IntroductionIntroduction Module 1Lesson 1 - The Context for Business Process ModellingTest Your Knowledge Quiz Module 2Lesson - Modelling at Enterprise LevelTest Your Knowledge Quiz Module 3Lesson - Modelling at Event-Response LevelTest Your Knowledge Quiz Module 4Lesson - Modelling at Actor-Task LevelTest Your Knowledge Quiz Module 5Lesson - Improving Business ProcessesTest Your Knowledge Quiz
This Level 2 Babysitting is perfect for students who want to enhance their understanding of babysitting and aspire to achieve a career in a daycare centre, nursery or pre-school setting. This qualification provides a thorough understanding of the skills required for babysitting. It includes the babysitter's responsibilities to the children they care for and their responsibilities to the parents, accident prevention, and fire safety. This Level 2 Babysitting course is the perfect way to kickstart your career in the childcare industry. Enrol today and take the next step towards your personal and professional goals. Learning Outcomes After completing this Level 2 Babysitting Bundle course, the learner will be able to: Understand the role of control measures in fire safety and accident prevention. Know how to care for young children in a babysitting environment. Understand the benefits of craft activities for young children. Know how to respect and value children. Understand children's rights. Why Choose Level 2 Babysitting Bundle Course from Us Self-paced course, access available from anywhere. Easy to understand, high-quality study materials. Level 2 Babysitting Course developed by industry experts. MCQ quiz after each module to assess your learning. Automated and instant assessment results. 24/7 support via live chat, phone call or email. Free PDF certificate as soon as completing the course. << Course Included >> Main Course: Level 2 Babysitting << Free Courses >> Course 01: Advanced Diploma in Child Care Course 02: Child and Adolescent Mental Health Course << Others >> Free 3 PDF Certificate Lifetime Access Free Retake Exam Tutor Support [ Note: Free PDF certificate as soon as completing the Level 2 Babysitting course] Course Curriculum of *** Level 2 Babysitting *** Module 01: Accident Prevention and Fire Safety When Babysitting Understand Risk Assessment and Its Role in Supporting the Babysitter Know How to Assess Risks in a Babysitting Environment Understand the Role of Control Measures in Fire Safety and Accident Preventions Module 02: Caring for Young Children in a Babysitting Environment Understand Responsibilities in Relation to Babysitting Know Age-Appropriate Toys and Activities for Young Children from Birth to 5 Years 11 Months Know How to Prepare a Young Child for Sleep Module 03: Craft Activities with Young Children Understand the Benefits of Craft Activities for Young Children Understand Health and Safety when Providing Craft Activities for Young Children Module 04: Respecting and Valuing Children Know How to Respect and Value Children as Individuals Understand Ways to Respect and Value Children Know that Children Have Rights Assessment Method After completing each module of the Level 2 Babysitting Course, you will find automated MCQ quizzes. To unlock the next module, you need to complete the quiz task and get at least 60% marks. Once you complete all the modules in this manner, you will be qualified to request your certification. Certification After completing the MCQ/Assignment assessment for Level 2 Babysitting course, you will be entitled to a Certificate of Completion from Training Tale. It will act as proof of your extensive professional development. The certificate is in PDF format, which is completely free to download. A printed version is also available upon request. It will also be sent to you through a courier for £13.99. Who is this course for? This Level 2 Babysitting course is perfect for anyone who interested in learning about baby-sitting. Furthermore, if you work in any of the following fields, you must complete Level 2 Babysitting course. Requirements Students who intend to enrol in this Level 2 Babysitting course must meet the following requirements: Good command of the English language Must be vivacious and self-driven Basic computer knowledge A minimum of 16 years of age is required Career path This Level 2 Babysitting course will help you get the job you want in the relevant field. Regardless of your current job status and also the course will advance your career. Certificates Certificate of completion Digital certificate - Included