2110 Professional Development courses delivered On Demand

Level 7 Diploma (FREE QLS Endorsed Certificate)| 11 CPD Courses+11 PDF Certificate| 150 CPD Points| CPD & CiQ Accredited

Level 5 Diploma(FREE QLS Endorsed Certificate)| 12 CPD Courses+12 PDF Certificates| 150 CPD Points| CPD & CiQ Accredited

Level 4 Diploma(FREE QLS Endorsed Certificate)| 11 CPD Courses+11 PDF Certificates| 140 CPD Points|CPD & CiQ Accredited

Level 4 Diploma(FREE QLS Endorsed Certificate)| 11 CPD Courses+11 PDF Certificates| 140 CPD Points|CPD & CiQ Accredited

Level 5 QLS Endorsed Diploma | 150 CPD Points | +Gifts: QLS Certificate + PDF Certificate | 24/7 Learner Support

This course is suitable if you work or want to work as a teacher/trainer/tutor in Further Education Colleges, adult and community education, the voluntary sector, commerce, industry, the public sector or HM forces.

Level 5 QLS Endorsed Diploma | 150 CPD Points | +Gifts: QLS Certificate + PDF Certificate | 24/7 Learner Support

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 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.

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.