Introduction to Clinical Trials for the Pharmaceutical Sector programme will provide learners with a comprehensive overview of the phases of clinical trials, and the quality, regulatory and organisational aspects of clinical trials for the pharmaceutical sector.
Aims and Objectives
The aim of this programme is to introduce learners to the broad field of clinical research and provide an understanding of the importance of clinical trials for the pharmaceutical industry. Learners will gain knowledge of the drug development life cycle, phases of clinical trials, good clinical practice and pharmacovigilance. Participants will also be advised of the current regulatory requirements when conducting clinical research.
Course Content
Introduction to clinical research
Drug development life cycle
Phases of clinical trials
Pharmacovigilance
Good clinical practice guidelines (GCP)
Governing regulations related to clinical trials
Learning Outcomes
On completion of this programme the learner should be able to:
- Appreciate the importance of clinical research and understand the key concepts of clinical trials
- Outline the development lifecycle for a typical drug in the pharmaceutical industry learning works
- Identify the four phases of clinical trials and understand the regulations governing the conduct of clinical trials, within the EU and the US
- Understand and appreciate the importance of Good Clinical Practice (GCP), ethics and pharmacovigilance
Other courses options include
- Introduction to Technical Writing for the Manufacturing Sector
- Advanced Technical Writing for the Manufacturing Sector
- Introduction to cGMP for the Bio-Pharmaceutical Industry
- Introduction to Validation for the Pharmaceutical Sector
- Introduction to Quality Control for Bio-Pharmaceutical Manufacturing
- Certificate in Supply Chain (Special Purpose Award/QQI Level 6 20 credits)
- Certificate in Operational Excellence (Special Purpose Award/QQI Level 6 25 credits)
