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Programme Modules
Module 1 : Introduction to Clinical Research Industry and Basics of Clinical Trials
Module 2 : Drug Development Process
Module 3 : Ethics and Ethical Guidelines for Clinical Trials and Good Clinical Practice (GCP): ICH Good Clinical Practice E6 (R2)
Module 4 : Indian GCP and Schedule Y
Module 5 : Regulations Guiding the Clinical Research Industry- History and Basics of National and International Regulatory Bodies
Module 5 : Essential Documents in Clinical Trials: Protocol, CRF, Inform Consent, Investigator’s Brochure, Study Progress Report
Module 5 : Clinical Trials -Latest updates : New Drugs and Clinical Trials Rules, 2019
Module 5 : Industry Based Case Studies
Programme Deliverables
The accompanying training is appropriately aligned with the current Industry’s expectations.
Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
• All the efforts are made to make the entire programme modules easily understandable.
• Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
• At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
• All learning and training delivery initiatives shall be conducted in English.
Future career prospects of Good Clinical Practices
Pharmaceutical professionals need to ensure that their skills should be up-to-date with the latest regulations. The good clinical practice guidelines ensure that clinical trial participants are protected during the research process. This certificate programme will help professionals, strengthening their skills and experience in this field.