Clinical Research is an inevitable part of the healthcare market world over. Whole healthcare industry from pharmaceutical producers to consumers, all trust the credibility of trials done and safety data accumulated by the Clinical Research group behind each new drug, cosmetic product, food supplement or any other healthcare consumable product or device launched in the market.
The Post Graduate Diploma in Clinical Research has been structured by experts from the industry themselves and thus comprehensive coverage and understanding of the industry and its functional areas is promised. The goal of the Post Graduate Diploma Programme is to familiarize the participant with the updated theoretical and practical aspects of the Clinical Research. The diploma course has the following tempting features which are definite to benefit one to all participants of the course:
- Comprehensive information about the clinical trial execution and statistics, which clearly targets the healthcare industry;
- Current Regulations and Ethics followed;
- Case studies based teaching
Module 1: Introduction to Clinical Research Industry and Basics of Clinical Trials.
Module 2: Pharmacology-Concepts and Application in clinical trials.
Module 3: Drug Development Process.
Module 4: Ethics and Ethical Guidelines for Clinical Trials and Good Clinical Practice (GCP).
Module 5: Regulations Guiding the Clinical Research Industry- History and Basics of National and International Regulatory Bodies.
Module 6: Outsourcing Clinical Trials, functioning of Clinical Research Organisations.
Module 7: Biostatistics- Concepts and Application in Drug Development and Clinical Research.
Module 8: Clinical Trials- Phases and Trial Designs.
Module 9: Documentation and Data Management in Clinical Trials.
Module 10: Safety Reporting Techniques and Pharmacovigilance.
Module 11: Quality Control and Clinical Trial Management.
Module 12: Clinical Trials- Medical Devices.
Module 13: Protocol Writing and Designing.
Module 14: Clinical Trials -Latest updates : New Drugs and Clinical Trials Rules, 2019.
Module 15: Industry Based Case Studies.
1: Preparation of clinical trial protocols and final clinical trial reports.
2: INDA, NDA, BLA, Informed consent form filling.
3: Preparation of PSUR for submission in EU.
4: Preparation of CTD/eCTD dossiers for submission in regulatory agency.
5: Preparation of an IMPD for EU submission.
6: Designing case report forms and EDC.
7: Drug development process and its filing.
9: Training on CTMS.
10: Preparation of SOPs and work manuals for quality trial management.
Experimental training along with the lectures from expert professionals will help the participant to learn the practical aspects of clinical trial process. After the course completion, the participant is expected to have extensive and up-to-date knowledge of clinical research industry and pharmacology, PSUR for adverse reaction reporting, filling process of India and International countries -NDA, INDA, EDC, CTD/eCTD, IRB, BLA and Informed Consent Form, Clinical Trial Management System (CTMS), preparation of protocol and case report forms (CRFS), etc.
Any Indian or overseas applicants must fulfill following criteria for enrolling into the one year Good Manufacturing Practices program. The applicant must be a graduate in any discipline.
Minimum duration to complete this programme is 12 months
The registration dates for this annual program run by the institute are updated timely on the webpage.
All the efforts will be made in the form of 6 weeks internship to provide industrial exposure to the students through internship with pharmaceutical company so that they can have good practical knowledge beyond the classroom experience.
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 obliged to appear for annual exam at the end of the course. After successful completion, the participants will be awarded Post Graduate Diploma in Clinical Research. For all the above mentioned modules elaborate course material and project work details 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. The robust placement cell comprises of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. We are engaged in promoting the employability of our participants by maintaining good rapport and relation with HR cell and recruiting managers of leading healthcare companies across the globe.
The efforts of our placement cell also include helping with professional resume writing, interview skills & conducting mock interviews etc.
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, Accenture, Wipro, Fortis Clinical Research, Quintiles, SeQuent, PepsiCo India, Mankind, Beryl Drugs, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Biocon, Apollo Hospitals, etc.
IGMPI offers professional and industry oriented training in Clinical Research thus opening doors for entry into the industry. PG diploma in CR adds advantage for those already in the industry as a tag of professional training and those new to the industry feel comfortable with backing of apt and up-to-date information and training required to sustain and grow in the industry.
PG Diploma in Clinical Research is a broad spectrum course which offers to entail the candidate with knowledge and practically important information about the industry type, working modalities, methodology of trials, techniques of quality control, drug development, post marketing safety checks and all other aspects related to the clinical research industry. With the completion of this course the candidate gets to select from varied work areas of the industry/sector of his/her interest. Knowing all faces of the industry, candidate can target to specifically enter the drug development, CTs, Data Management, Regulatory Affairs, Quality Assurance or Post marketing Surveillance teams of various Pharmaceutical companies. Same is true for the professionals who are already a part of the industry but are keen on making lateral movement in their company by shifting to other department.
Mr Vinod Arora, Principal Advisor, IGMPI
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like