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Unleash your inner editor with our comprehensive copyediting and proofreading course. Master the skills to polish your writing to perfection and become a sought-after professional.

his module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the MRP.

This module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the DCP.

A comprehensive web development course that will help you understand 'why' things work and not just 'how'. Learn to write better code to boost your website traffic; know how to precision fix and tweak behavior and performance; improve your market penetration and your margins. Everything you need to know about the Critical Rendering Path, AJAX, and HTTP is right here at your fingertips.

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 outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. The use of information in the ‘Orange Book’ is explained, as is the role of patent certification in the application. The importance of establishing bioequivalence between a generic and its reference product is emphasised. The module specifies the content and format requirements for an ANDA submission and describes the FDA’s review and approval process. An outline is given of the Generic Drug User Fee Amendments (GDUFA) and the law’s effects on industry players.

Level 5 QLS Diploma | Free 9 CPD Courses | FREE QLS Endorsed Hard Copy Certificate & PDF Certificates | Tutor Support

Level 5 Diploma (Free QLS Endorsed Certificate) | 11-in-1 Bundle | Free Certificates | CPD Accredited | Lifetime Access

This course is designed for complete beginners, where you will develop iPhone applications by building five complete apps using SwiftUI 3 code and Xcode 13. You will not only build the apps but also learn how to submit and upload apps to the App Store and share your creation with the world.