53333 Courses delivered Online

Our 2023 online courses work in the same way that our classroom courses do, but they are completed via the online platform Zoom. The course can be completed on any device that the Zoom app can be used on, such as a PC, laptop, tablet or smart phone. As with our face to face driver CPC training, completion of this remote learning course will gain you 7 hours towards your CPC. To book your place on the course, simply click on the link below, and complete the online booking form. These details will be used to produce a registration document and provide you with a course certificate on successful completion of the course. Course Details: Course Duration: 7 hours Course Cost: £69.95 including VAT and DVSA upload fees

Level 5 Diploma | FREE QLS Endorsed Certificate | 10 CPD Courses & PDF Certificates | 170 CPD Points| Lifetime Access

Level 4 QLS Diploma | FREE QLS Endorsed Certificate | 10 CPD Courses & Certificates | 220 CPD Points | CPD Accredited

Level 5 QLS Course With QLS Endorsed Certificate | 11 CPD Courses & PDF Certificates | 160 CPD Points | CPD Accredited

This eLearning course is suitable to refresh your DSL training every 2 years for you and your safeguarding team.

This course will show you how to create a professional and attractive user interface (UI) in Django for data science using the Semantic UI framework.

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.

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.

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.