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Course Description

Know more about Good clinical practice (GCP) guidelines that govern important aspects of clinical trials to ensure patient safety and scientific integrity. “GCP” is a quality standard which refers to the document put forth by the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH is a group made up of regulatory officials from the United States, Europe, and Japan, as well as representatives from the pharmaceutical industry. Additionally, a similar of guideline, ISO 14155:2011 has also been established by the International Organization for Standardization (ISO) and is used throughout the European Union and generally accepted globally. While not regulatory documents in themselves, these two guidelines serve as the basis for legislation in many countries around the world.

Who is the target audience?

Healthcare professionals and clinical staff new to the domain (like nurses, etc.)

What am I going to get from this course?

  1. Understand the processes and orders within the drug birth & differentiating between clinical research and clinical practice
  2. Describe the process from SIV to COV including MV processes
  3. Understand safety requirements in clinical trials
  4. Zooming within a project and highlighting monitoring and frauds, for better interaction sponsor-investigator and better outcome and compliance
  5. Explain Fraud & Misconduct: Difference, Types and Importance in Clinical research
  6. List the ethics of clinical research and importance of confidentiality (Importance of doctor – patient communication)