Introduction to Clinical Research (A003)

2 day course and workshop

The main objective of this course is to provide the participant with a clear picture of clinical research. Regulatory requirements and Good Clinical Practices are going to be reviewed in a summarized manner to allow easy comprehension and learning. It’s a MUST attend course for the recent graduate who is planning to start a career in the pharmaceutical industry.

Course Overview

This intensive 2 day course and workshop is designed to provide the participant with an insight in the world of Pharmaceutical Research and Development. Graduates from scientific and health related disciplines will learn the main points of Drug development and the pharmaceutical industry, regulatory requirements for clinical research (FDA), and Good Clinical Practices as an international guideline for clinical research. The course will provide also with the basis of the responsibilities the sponsor, medical investigator and institutional review boards have when involved in clinical research. The participant will also learn to differentiate medical practice, experimental medicine and clinical research and the regulatory frameworks. The patient information and consent process and documents will be thoroughly examined as well as the clinical trial documents: the protocols, investigators brochures and case report forms. The main new technologies that assist clinical trials will be discussed as well as inspectional strategies for clinical trials.
Course Outline
  • Pharmaceutical product development (drugs, devices, biotech products and vaccines)
  • Principles of pharmacology
  • Phases in Clinical Research
  • FDA regulatory requirements for clinical trials
  • God Clinical Practices
  • Safety Reporting
  • The investigator site, coordinating clinical trials
  • The sponsors trial master file
  • Patient Information and Consent process
  • Monitoring Clinical Trials
  • Auditing Clinical Trials
  • Standard Operational Procedures in Clinical Research

Who Should Attend

This is a must attend course for all professionals who wishes to start a career in the following areas:

  • NEW GRADUATES, Science and health care graduates who wishes to enter the exciting world of clinical development
  • Consultants
  • Medical writers
  • Pharmaceutical regualtroy affairs
  • Product developement
  • Quality assurance
  • and more