Good Clinical Practice (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 exam implies that the participant has in-depth knowledge and clear understanding of industry guidelines and regulations. The study material 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.
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
Any Life Science graduate/ B.Pharm/M pharm/MSc/ any diploma holder or passed outs of Clinical Research degree or diploma courses are eligible for these course. Working professionals of any of the following industry types Drugs manufacturing, Medical Device, Ayurveda, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurveda Medicine Manufacturing, Cosmetic Manufacturing, Biotechnology or any related industry are highly encouraged to apply for the programme.
The candidate is expected to complete the course in 3 months.
The registration dates for this programme run by the institute are updated timely on the webpage. Effective E-learning tools incorporated into the design of the webpage make the course lectures, videos and study material easily accessible. This gives huge window of self regulated and self-paced performance to the participants.
IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.
All the participants are expected to appear for online exam and are also obliged to submit assignments after each module. After successful completion the participants will be awarded Certificate in Good Clinical Practices. For all the above mentioned modules elaborate course material, assignment and case studies would be provided by the Institute from time to time. Details get updated on the webpage as well.
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 and food giants like Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, 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 and Food industries on regular basis.
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 course will help professionals, strengthening their skills and experience in this field.
Mr Vinod Arora, Principal Advisor, IGMPI
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like