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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.

The eCTD is mandatory for all applications for marketing approval and all subsequent related submissions in the European Economic Area, the USA and Canada. Other countries intend to make its use mandatory. The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of medicinal product dossiers for regulatory applications. It broadens the scope of the CTD to include information on variations, renewals and amendments, so that it is no longer a static document but is updatable throughout the life of the product. This module outlines the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission. The module provides a training and reference tool that will be of particular value to those new to the use of the format.

The CTD is the internationally recognised standard format for submissions to medicines regulatory authorities. In the European Economic Area, the USA and Canada, the CTD, in its electronic format (eCTD), is mandatory for all applications for marketing approval and all subsequent related submissions. The CTD is accepted in many other countries, being mandatory for new prescription medicines in some. This module explains the rationale for the CTD and provides guidance on its structure and format and the ways in which it is used.

Managing Successful Programmes (MSP®) 5th Edition Foundation: On-Demand MSP certification provides guidance for programme managers, business change managers and the next step for project managers to develop their knowledge and skills to be able to positively respond to the challenges for managing programmes and larger, more strategic or multiple projects. What you will Learn At the end of this course, participants will be able to: Understand key concepts relating to programmes and MSP Understand how the MSP principles underpin the MSP framework Understand the MSP themes and how they are applied throughout the programme Understand the MSP processes and how they are carried out throughout the programme Key Concepts of MSP Programmes Three Lenses of MSP Principles Themes and Governance Organization Organization Theme Organization Structure Individual Roles Stakeholder Management Design Design Theme Benefits Risk Identification and Prioritization Target Operating Model Documents and Key Roles Justification Justification Theme Business Case Financial Planning Documents and Key Roles Structure Structure Theme Delivery Planning Dependencies Benefits Realization Plan Resourcing Documents and Key Roles Knowledge Knowledge Theme Knowledge Management Information Management Document and Key Roles Assurance Assurance Theme Assurance at Multiple Levels Assurance Planning Document and Key Roles Decisions Decisions Theme Issue Resolution Risk Response Data Gathering and Reporting Options and Analysis Document and Key Roles MSP Processes Identify the Programme Design the Outcomes Plan Progressive Delivery Deliver the Capabilities Embed the Outcomes Evaluate New Information Close the Programme About the MSP 5th Edition Foundation Exam 60 multiple-choice questions 1-hour Closed-book Candidates require a minimum of 36 correct answers (60%) to pass

Premium Bundle of all Time | Ofqual Regulation + ATHE Awards + CPD Accreditation | Assessment & Tutor Support Included

Premium Bundle of all Time | Ofqual Regulation + ATHE Awards + QLS Endorsement | Assessment & Tutor Support Included

Course Overview Watercolour paints are ideal for creating scenes of nature, still life and breathtaking landscapes. In this complete training course, you will learn how to master the watercolour art form to create truly striking pieces of artwork that can be used in your professional portfolio. Through the Watercolor Workout Basics and Beyond course, you will learn how to paint a basic tree and mountain scene, with step-by-step guidance. It also includes tips and guidance such as how to blend drawing and painting to create high-quality artwork.  Whether you are a complete beginner or want to take your knowledge to the next level, this course will teach you the foundations of watercolour painting that will build your artistic skills in no time and set you up to become a professional artist in no time. This best selling Watercolor Workout Basics and Beyond has been developed by industry professionals and has already been completed by hundreds of satisfied students. This in-depth Watercolor Workout Basics and Beyond is suitable for anyone who wants to build their professional skill set and improve their expert knowledge. The Watercolor Workout Basics and Beyond is CPD-accredited, so you can be confident you're completing a quality training course will boost your CV and enhance your career potential. The Watercolor Workout Basics and Beyond is made up of several information-packed modules which break down each topic into bite-sized chunks to ensure you understand and retain everything you learn. After successfully completing the Watercolor Workout Basics and Beyond, you will be awarded a certificate of completion as proof of your new skills. If you are looking to pursue a new career and want to build your professional skills to excel in your chosen field, the certificate of completion from the Watercolor Workout Basics and Beyond will help you stand out from the crowd. You can also validate your certification on our website. We know that you are busy and that time is precious, so we have designed the Watercolor Workout Basics and Beyond to be completed at your own pace, whether that's part-time or full-time. Get full course access upon registration and access the course materials from anywhere in the world, at any time, from any internet-enabled device.  Our experienced tutors are here to support you through the entire learning process and answer any queries you may have via email.

Premium Bundle of all Time | Ofqual Regulation + ATHE Awards + CPD Accreditation | Assessment & Tutor Support Included

Premium Bundle of all Time | Ofqual Regulation + ATHE Awards + QLS Endorsement | Assessment & Tutor Support Included

Premium Bundle of all Time | Ofqual Regulation + ATHE Awards + CPD Accreditation | Assessment & Tutor Support Included