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Level 5 QLS Endorsed Course | Endorsed Certificate Included | Plus 5 Career Guided Courses | CPD Accredited

Start your Journey to Becoming a Successful Project Manager, without waiting for other People to See your Potential

In this comprehensive course, we will guide you through the world of Oracle Database Administration, starting from the basics and equipping you with the skills to create databases, manage storage, implement backup plans, apply patches, troubleshoot issues, and excel in the role of a professional DBA.

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.