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Changes to the terms of marketing authorisations for medicinal products, called variations in Europe, must be notified to or approved by the relevant regulatory authorities. Variations include changes to the composition of products, their manufacturing processes, the way they are used, or the indications for which they are authorised. Common approaches are adopted within the European Economic Area to variations to marketing authorisations approved through the Centralised, Decentralised or Mutual Recognition Procedures. Recent legislation has substantially modified the regulatory requirements and extended them to purely national authorisations by member states. This module, which is fully up to date with the new legislation, covers the classification of variations into their several types and the regulatory requirements, guidance and procedures to be followed for each type.

The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than producing generic drugs. The US legal framework for the licensure of follow-on biologics, and accompanying regulatory guidance from the Food and Drug Administration (FDA), have been established only in recent years.

This module describes the requirements that must be met to obtain licensure of a biological product. Subjects covered include the regulatory context, the content and format of the BLA submission, the review process, and provisions for expedited development and review.

Having undergone Installation Qualification, before equipment can be used routinely in production, it needs to undergo Operational Qualification (OQ) and Performance Qualification (PQ). This module describes OQ and PQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.

Before equipment can be used routinely in production, it must first be commissioned and, if necessary, undergo Installation Qualification (IQ). This module describes commissioning and IQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.

This foundation-level module is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe. The legal framework and the roles of major players in regulation are presented. The life-cycle of a drug is outlined. The various procedures available for assessment and approval of products are described and their requirements outlined. Obligations to be fulfilled after marketing approval are discussed.

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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

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