Good Clinical Practice And Regulatory Updates

This course provides a comprehensive overview of Good Clinical Practice (GCP) and the regulatory landscape surrounding clinical trials. It covers the historical development of ethical guidelines, ethical issues in clinical trials, the functioning and responsibilities of Ethics Committees, new drug and clinical trial regulations, and the intricacies of compensation in clinical research.

Module 1 : Historical Development of Ethical Guidelines

  • History of Clinical Trials
  • Declaration of Helsinki
  • Foundation of GCP
  • Responsibilities of Sponsor
  • Responsibilities of Monitors
  • GCP Guidelines

Module 2 : Ethical Issues in Clinical trials

  • History of Clinical Trials
  • Guatemala Trial 1946-1948
  • Ethical Conduct of Clinical Trials
  • Informed Consent Document
  • Payment and Compensation
  • Biomedical Material and Data

Module 3 :Functioning of Ethics Committee (EC) and Responsibilities of EC Member

  • Ethics Committee (EC) Composition
  • Roles and Responsibilities of EC
  • Types of Review
  • Role of Individual Members of EC
  • Roles of Individual Members of EC
  • Ethics Committee for CTA (Clinical Trial Agreement), BA/BE study
  • Ethics Committee for Biomedical and Health Research
  • Clinical Trials, BA/BE study of New Drugs and IND (Investigational New Drug)
  • Compensation
  • BA/BE Study Centre
  • General Principles and Practices for Clinical Trials
  • Requirements and Guidelines for Permission to Import or Manufacture of New Drug for Sale to Undertake Clinical Trial
  • Conduct of CT
  • Requirements and Guidelines for conduct of BA/BE Study of New Drugs or INDs

Module 4 : New Drugs and Clinical Trials Rules (NDCT)

  • Guidelines for Clinical Trials in India
  • Why do we need Guidelines?
  • Salient Features
  • Chapters of NDCT (New Drugs and Clinical Trials Rules)
  • Schedules of NDCT (New Drugs and Clinical Trials Rules)
  • Chapter 1: Preliminary
  • Chapter 2: Authorities and Officers

Module 5 : Compensation in Clinical Trials and Biomedical Research

  • Need of Regulation
  • Which regulations to follow for Compensation in Clinical Research?
  • How to Calculate the Compensation?
  • Timelines for Calculation of Compensation

Certificate In FCPM [ Online ]

Duration : 4 hrs/ week (2 days/week)

Schedule : Session of 2 hours twice a week

Batches Starting From August 2024​

Enroll Now For Early Bird Offers ( 10% Discount In Both Modes )

Certificate In FCPM [ Offline ]

Duration : 4 hrs/ week (2 days/week)

Schedule : Session of 2 hours twice a week

Perks Of Offline Course

Role Play
Get to work on live projects
Face-to-face guidance by PM
Clinical on-site exposure