The Drug Development Process from Concept to Market

This course is designed to cater for employees of pharmaceutical companies who would like an understanding of the drug development and regulatory approval process. The course starts by considering the global pharmaceutical market, important therapeutic areas and the roles of different pharmaceutical professionals in the development process, as well as a definition of drugs and medical devices. The drug development process, from discovery to post-marketing surveillance, is then explained. Topics include the identification of drug targets, synthesis of chemical drugs and the development of biologics, pharmacokinetics and toxicity screening, pre-clinical development, clinical studies, regulatory submissions, managing post-approval change, pharmacovigilance and an overview of regulations governing drug manufacture and distribution.

Learning Objectives:
By the end of this course, you will understand:

The size of the global pharmaceutical market and the key therapeutic areas being addressed by innovator companies
The roles of different pharmaceutical professionals
Typical costs and timelines associated with drug development
How new drugs are developed against targets in the human body
Reasons why drugs fail during development
Factors affecting oral bioavailability
How drugs are screened for toxicity
The potential influence of polymorphism, salt form and isomerism on efficacy and safety
How formulation can affect drug performance
How the safety and efficacy of drug products are ensured during QC release testing
The information obtained at each stage of clinical research
The structure of regulatory submissions
How post-approval changes to drug products are managed
How the manufacture and distribution of marketed drug products are controlled

Who will Benefit:
Non-scientific employees of pharmaceutical companies who would like to understand how drugs are developed (e.g. IT, human resources, engineering and administrative staff)
Recently-appointed scientific staff with no previous experience of the pharmaceutical industry
Any pharmaceutical employee wishing to improve their knowledge of drug development