211 ABB courses delivered Online

Take our part-time online “Conversion Course into Pharmaceutical Manufacturing“ NO Previous Industry Experience or Science Qualifications Required

This course leads to the Mediterm Intermediate Award in Medical Terminology (Level 2), studied over approximately 12 weeks (taking more or less time dependent on learner requirements). This course is suitable for those already working in healthcare or those who wish to start a new career in healthcare.

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.

Enhance your healthcare communication skills with our Medical Terminology and Abbreviation Course. Covering essential vocabulary, acronyms, and body systems, this course is perfect for aspiring professionals and current workers seeking to improve their understanding and application of medical language. Complete the course at your own pace and receive a certificate of achievement.

Level 3, 4 & 7 QLS Endorsed Diploma | QLS Hard Copy Certificate Included | Plus 10 CPD Courses | Lifetime Access

24 Hour Flash Deal **33-in-1 Leadership and Management for Residential Childcare Mega Bundle** Leadership and Management for Residential Childcare Enrolment Gifts **FREE PDF Certificate**FREE PDF Transcript ** FREE Exam** FREE Student ID ** Lifetime Access **FREE Enrolment Letter ** Take the initial steps toward a successful long-term career by studying the Leadership and Management for Residential Childcare package online with Studyhub through our online learning platform. The Leadership and Management for Residential Childcare bundle can help you improve your CV, wow potential employers, and differentiate yourself from the mass. This Leadership and Management for Residential Childcare course provides complete 360-degree training on Leadership and Management for Residential Childcare. You'll get not one, not two, not three, but thirty-three Leadership and Management for Residential Childcare courses included in this course. 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A 505(b)(2) New Drug Application (NDA) is a submission to the Food and Drug Administration (FDA) for approval to market a drug in the USA. It differs from a ‘stand-alone’ NDA in that some of the data on which the applicant relies to demonstrate safety and efficacy have been obtained from publicly available sources rather than from the applicant’s own studies. The applicant typically proposes to market a drug that is based on an approved reference product but modified in its formulation or uses. A 505(b)(2) NDA also differs from an Abbreviated New Drug Application (ANDA) for approval of a generic drug in that the applicant’s product need not be a duplicate of the reference listed drug. The 505(b)(2) pathway may be said to lie part-way between the ‘stand-alone’ NDA and generics pathways, offering a unique combination of advantages to developers. It facilitates the modification of drugs to address unmet medical needs. The 505(b)(2) application pathway accounts for about half of all new drug approvals in the USA.

Level 3 & 4 Endorsed Diploma | QLS Hard Copy Certificate Included | Plus 5 CPD Courses | Lifetime Access

It can be daunting starting to work in the aviation industry due to the amount of abbreviations and technical jargon being used. This course provides a basic understanding of key terminology and different roles within the airport. It is ideal to provide a basic level of knowledge to support a job application, for those new to the industry, or for experienced employees looking to fill in knowledge gaps. Aligned to IATA AHM 1110, 11.2, GEN01. Complete within 6 months of issue. Bulk discounts available for multiple licenses.