Certificate in Good Clinical Practices

(GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted. Compliance with GCP provides public assurance that the rights, safety and wellbeing of research participants are protected and that research data are reliable. This certificate programme is aimed at improving the conceptual knowledge of the participant for Good Clinical Practices and resolving any dilemmas that a working professional may face regarding the application of GCP guidelines at his workplace. Successful performance in this programme implies that the participant has in-depth knowledge and clear understanding of industry guidelines and regulations. The training has been carefully designed to introduce the attendee to various aspects and basics of GCP, its need and benefits in assuring the ethical and scientific integrity of clinical trials. GCP compliance provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. Several specialized topics have been added to guide the participant through ICH GCP regulations, compliance needs, comparison of Indian GCP guidelines vs. ICH GCP guidelines etc.

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: Clinical Trials -Latest updates : New Drugs and Clinical Trials Rules, 2019

Module 9: Industry specific case studies

Eligibility

Any Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHMS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

Programme Duration

The candidate is expected to complete the programme in 3 months.

Registration

The registration dates for this programme run by the Institute are updated timely on the webpage. Effective online learning tools incorporated into the design of the webpage make the programme lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.

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.

Assessment & Certification

Online assessment will be conducted at the end of the programme and after successful completion; the participants will be awarded Certificate in Good Clinical Practice (GCP) by Institute of Good Manufacturing Practices India (IGMPI).

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare like Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Bliss GVS Pharma, SeQuent, Mankind, Beryl Drugs, Allergy Therapeutics, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy, Biocon etc. The IGMPI's Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

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.

View Prospectus

Programme Fee Details

How to apply

For further enquiries, write to or call us on:
info@igmpi.ac.in / 18001031071 (Toll Free), Phone: +91 11 26512850