Description
Getting a new pharmaceutical product to market involves a large amount of investment and a great deal of time. The module introduces the pharmaceutical industry and provides an informative overview of the stages of developing a new pharmaceutical product. The module then looks at the stages involved in the clinical testing of the new product by explaining the different types of clinical trials, the different phases of trials and the personnel involved in clinical research.
Who is the Module Designed For?
The module is designed for people who are new to clinical research, for administrators working in the area who would like to learn more about the environment in which they work. and for those who are considering a move into clinical research (for example wanting to become a CRA, CTA, data manager) whether it be in a pharmaceutical company, contract research organisation or in a health service/academic setting.
Course Content
Background to the Industry
 The Industry Today
New Product Development
Patent Protection
Product Discovery
Preclinical Development & Chemistry
Chemistry & Manufacturing Considerations
Clinical Development/Clinical Research
Stages of Clinical Research
Phase I & Early Stage Clinical Research
Phase II
Phase III
Late Phase
Phase IIIb
Phase IV
Post Marketing Surveillance (PMS)
Generic Products
Overview of Process for a Clinical Trial
Protocol
Obtain Relevant Approvals
Design Case Report Form (CRF)
Product Supply
Recruit, Manage & Monitor Subjects/Patients
Data Management
Analyse & Report Data
Organisations involved in clinical research
What Prior Knowledge is Needed?
None |
