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Programme Modules
Module 1: Introduction to Clinical Trials
Module 2: Overview of ICH- GCP Guidelines and its new revision
Module 3: Principles of ICH GCP- Responsibilities, Sponsor, Investigator and Ethics Committee
Module 4: Essential Documents- Informed Consent, Protocol and Investigator’s Brochure
Module 5: SAE Reporting, Audit & Inspection
Module 6: Consequences of GCP non-compliance
Module 7: GCP Guidelines for Medical Devices
Module 8: Industry-specific 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 by IGMPI faculty members 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.