+ 971 2 555 9394

PROGRAM OUTLINE

Good Clinical Practice

Duration: 2 days

Audience :

  • Medical department personnel in pharma industry
  • Clinical trial management personnel
  • Biometrics related personnel
  • Ethics committee members
  • Investigators and research personnel

Content

  • Drug development process
  • Introduction to GCP
  • Regulatory requirements
  • Independent Ethics Committee (IEC)
  • Investigator
  • Sponsor's Responsibilities
  • Monitor's Responsibilities
  • The Investigational product
  • Safety & Adverse Event Reporting
  • Clinical Trial Protocol and Amendments
  • Investigator’s brochure
  • Essential Document

On successful completion of the course, the participant will be able to:

  • Demonstrate an understanding of the importance of the interwoven laws, frameworks and guidelines which govern the set up and conduct of clinical research
  • Demonstrate an understanding of the roles and responsibilities of different individuals and organisations in clinical research
  • Identify a range of essential documents and the purpose of maintaining a trial master file
  • Understand the process of receiving informed consent and the roles and responsibilities of those involved in this process
  • Demonstrate the ability to correctly and accurately complete case report forms and other relevant documentation and understand the process for data query resolution
  • Demonstrate an awareness of the correct reporting requirements that ensure patient safety


Contact us at + 91 98672 67661 or info@pharmawisdom.com

Comment on this article on       
Clinical Trials, South East Asia, Challenges, regulatory, infrastructure, Ethics, Cultural issues, informed consent, translation