About FCRDS

Faculty of Clinical Research and Drug Safety (FCRDS) has been set up under the aegis of ‘Institute of Good Manufacturing Practices India'. Institute of Good Manufacturing Practices India, registered as a non-profit society ( under The Societies Registration Act,1860) with Government of India recognised by the Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India, accredited Vocational Institution of Ministry of Education, Government of India, approved training Institute of Food Safety and Standards Authority of India (FSSAI) and affiliated with Life Sciences Sector Skills Council (SSC) and Food Industry Sector Skills Council of National Skill Development Corporation (NSDC) -presents unique, friendly and interactive platform to get rid of all your GMP related glitches. GMP- is an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing. GMP in itself is the most dynamic part which witnesses frequent changes in terms of newer rules being added and older ones being renewed. Keeping self updated with current GMPs thus becomes inevitable to stay abreast with the changing industry needs and practices.

About IGMPI

The Institute of Good Manufacturing Practices India, registered under SR Act XXI of 1860, Government of India, recognised by Ministry of Commerce & Industry, accredited Vocational Institution of Ministry of Education, Government of India and approved by Food Safety and Standards Authority of India (FSSAI) presents a unique, friendly and interactive platform to get rid of all your GMP compliance related issues. GMP- an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing and sustainability services - in itself is the most dynamic part which witnesses frequent changes in terms of new rules being added and old ones being renewed. Thus, keeping oneself updated with current GMPs is essential to remain aligned with evolving industry requirement and standards.

Our team comprises knowledgeable professionals from diverse sectors such as Pharma, Healthcare, Food & Nutraceutical industries, pooling together their expertise, know-how, and practical experiences to create this GMP guide. IGMPI is moving hand in hand with technology advances and has gained recognition as a stronger and better education and training platform provider for professionals and students in the areas of GMP, Quality Assurance and Control, Pharma, Food & Nutrition and Healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice and Product Management. Our board of governors and specialists have collated their acumen and are offering state-of-the-art courses which includes GMP training, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR, Environment Social Governance (ESG), and Good Laboratory Practice in form of formal classroom studies, online/interactive programmes, online seminars, as well as onsite training programmes along with the knowledge of worldwide affairs of the industry. In short, a round-the-clock service is provided for any information in these areas required by anybody from around the country and abroad. Based on high standards of quality, the training programmes in Pharma, Healthcare and Food GMP, Quality Assurance and Quality Control, Regulatory Affairs, IPR, Pharma Product Management, Public Health, Hospital Management, Clinical Research, Pharmacovigilance, Medical Writing, Medical Coding, Nanotechnology, Drug Design and Discovery, Food QA&QC, etc., areas have been approved by Quality Council of India, which is an autonomous body and an accreditation authority for education & vocational training providers under the Ministry of Commerce & Industry, Government of India. IGMPI is duly licensed and certified by Bureau of Indian Standards (BIS) under Bureau of Indian Standards (Conformity Assessment) Regulations 2018.

Accreditation and Awards

Institute of Good Manufacturing Practices India (IGMPI) is registered as a non-profit society with its own Memorandum of Association and bye-laws under The Societies Registration Act, 1860, Government of India. IGMPI is an accredited Vocational Institution of Ministry of Education, Government of India.

The Post Graduate and Executive Diploma programmes of IGMPI in Good Manufacturing Practices, Regulatory Affairs, Intellectual Property Rights, Quality Assurance and Quality Control, Public Health, Nanotechnology, Hospital Management, Product Management, Sales and Marketing Management, Clinical Research, Medical Writing, Drug Discovery and Development, Pharmacovigilance, Medical Coding have been duly assessed and approved by Quality Council of India, Government of India based on fulfillment of QCI's following criteria:

1. Programme Content
2. Programme Design
3. Programme Material
4. Instructors
5. Class size & Attendance
6. Facilities
7. Evaluation of Students
8. Written Examination
9. Certificate

IGMPI is also approved by Food Safety and Standards Authority of India (FSSAI) (FSSAI ID: TPINS18). IGMPI® is licensed by Department of Food Safety & Drug Administration under the Drugs and Cosmetics Act, 1940 and registered under Food Safety and Standards Act 2006.

IGMPI has been conferred with the prestigious "BUREAU OF INDIAN STANDARDS (BIS) AWARD OF HONOUR 2023". QUALITY COUNCIL OF INDIA (QCI) has also conferred IGMPI with D.L. SHAH NATIONAL QUALITY AWARD, Certificate of Merit & ASSOCHAM has conferred IGMPI with the Services Excellence Award based on excellence of its services to the students and training participants.

Bureau of Indian Standards (BIS)

Bureau of Indian Standards (BIS) came into existence through an act of Parliament in 1987. BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. The Bureau is a Body consisting of 25 members representing both Central and State governments, Members of Parliament, industry, scientific and research institutions, consumer organizations and professional bodies; with Union Minister of Consumer Affairs, Food and Public Distribution as its President and with Minister of State for Consumer Affairs, Food and Public Distribution as its Vice-President.

Quality Council of India (QCI)

Quality Council of India is set up by the Government of India to establish and operate national accreditation structure and promote quality through National Quality Campaign. QCI is registered as a non-profit society with its own Memorandum of Association. QCI is governed by a Council of 38 members and Chairman of QCI is appointed by the Prime Minister on recommendation of the industry to the government. The Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, is the nodal ministry for QCI.

International Recognition

For providing its education and training services to overseas students, IGMPI is registered with the Directorate General of Foreign Trade, Government of India and our Export Import Code is AADCI7680Q.

IGMPI is an Institutional Member of the International Society for Quality in Health Care

Bureau of Indian Standards (BIS) is a member of International Organization for Standardization (ISO) and through the Indian National Committee (INC) which is a member of International Electrotechnical Commission (IEC). BIS is also a member of regional standards bodies like Pacific Area Standards Congress (PASC) and South Asian Regional Standards Organization (SARSO). India started taking part in IEC from 1911 and subsequently the then Indian Standards Institution (now BIS) took over the responsibility of Indian National Committee of IEC(INC-IEC) in 1949. Since then the INC-IEC is actively participating in the activities of the IEC both at the policy level and technical work and carrying out the responsibilities as member body of IEC Council. India is a member in Standards Management Board (SMB) of IEC since 2015.BIS has also signed Bilateral Cooperation Agreements (BCA)/Mutual Recognition Agreements (MRA) with the National Standards Bodies of several countries like Afghanistan, Bangladesh, Belarus, Egypt, European Union , Germany, Ghana, Greece, Indonesia, Iran, Japan, Jordon, Kenya, Kyrgyzstan, Mali, Mauritius, Nigeria, Russia, Saudi Arabia , Slovakia, Slovenia, Suriname, USA, UAE, Uzbekistan, Viet Nam, Bhutan, Brazil, Israel, Nepal, Pakistan and Sri Lanka.

National Accreditation Board for Certification Bodies (NABCB), Quality Council of India is a member of International Accreditation Forum (IAF) & Pacific Accreditation Cooperation (PAC) as well as signatory to its MLAs for Quality Management Systems, Environmental Management Systems and Product Certification. NABCB is also a Full Member of International Laboratory Accreditation Cooperation (ILAC) & Asia Pacific Laboratory Accreditation Cooperation (APLAC) as well as signatory to its MRAs for Inspection.

Post Graduate Diploma/Executive Diploma in Clinical Research

The Post Graduate Diploma/Executive 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 online programme has following tempting features which are definite to benefit one to all participants of the programme:

Comprehensive information, clearly targeting the healthcare industry; Well-structured programme, intelligently put together under guidance of industry experts from same field; Easy to use, browse and explore e-tools woven remarkably well into the programme make the study material, lectures, online database, examination preparation modules as well as assessment papers easily accessible. Online-tools make the programme self-paced and online exams make things easier and less complicated for the participants. Clinical Research Industry in constantly growing and recessions proof but at the same time very challenging and dynamic. Only professionally trained employees get to make their mark and reach pinnacles of success in this fast moving sector of the health care industry. Thus IGMPI targets to teach, train and polish aspirants in Clinical Research professionals with clear understanding and complete knowledge of this industry and its working.

The programme is meant for all those keen on being a part of Clinical Research industry, so all graduates, post graduates and even working professionals can apply for the programme and affirm a strong position in the industry.

Programme Modules

Module 1: Introduction to Clinical Research Process

• Clinical Research Industry
• Difference between Clinical Research and Clinical Trials
• Clinical Research Terminologies
• General Medical Terminologies

Module 2: General Pharmacology and Mechanism of Drug Action

• Basics of Pharmacology
• Pharmacodynamics
• Pharmacokinetics
• Routes of Administration
• Dosage forms

Module 3: Drug Development Process and Clinical Drug Development Phases

• Drug discovery
• Target Identification
• Lead Identification
• Lead Optimization
• Preclinical studies

Module 4: Historical Perspectives of Clinical Research

• Evolution of Ethical and Regulatory Framework
• Nuremberg Code, 1946
• Declaration of Helsinki
• Thalidomide Tragedy
• Belmont Report
• Schedule Y, Drugs and Cosmetics Act 1945

Module 5: Ethical Issues in Clinical Research

• History of ICH
• ICH Guidelines
• ICH GCP- E6 R2
• ICMR Ethical Guidelines
• Ethics on use of Placebo in Clinical Trials

Module 6: National and International Regulations Governing Clinical Trials

• CDSCO, India
• ICMR, India
• USFDA, USA
• EMEA, Europe
• MHRA, UK
• TGA, Australia 

Module 7: Clinical Research Stakeholders and Core Team: Roles and Responsibilities

• Investigator
• Sponsor
• Contract Research Organization (CRO)
• Clinical Research Coordinator (CRC)
• Clinical Research Associate (CRA) 

Module 8: Research Methodology and Applied Biostatistics

• Defining the Research Problem
• Sampling Design
• Hypothesis testing
• Parametric and Non parametric test
• Scientific Writing

Module 9: Types and Designs used in Clinical Research

• Diagnostic and Treatment Trials
• Interventional and Observational studies
• Case control and Cohort studies
• Randomized controlled trials
• Quasi experiments

Module 10: Clinical Research Documentation

• Essential Documents before, during and after the trial_ICH GCP
• Protocol
• Informed Consent Documents
• Investigator’s Brochure
• Case Report Form
• Clinical Study Report 

Module 11: Clinical Trial Data Management

• Introduction to data management
• Electronic Data Records
• E-CRF & Interactive Web Response Systems
• Database locking and unlocking
• Good Documentation Practices

Module 12: Pharmacovigilance and Safety Monitoring

• Adverse Drug Reaction
• Serious Adverse Events (SAE)
• SAE Reporting timelines
• Pharmacovigilance methods
• Signal Detection and Data Mining
• PvPI
• Risk Management Plan 

Module 13: Quality Assurance and Quality Control in Clinical Trials

• Introduction to Quality Management System
• Quality Assurance
• Quality Control
• Audits and Inspection
• Types of Audits
• General Audit Observations 

Module 14: Pharmacoepidemiology and Pharmacoeconomics

• Pharmacoepidemiology- Methods
• Clinical Application of Pharmacoepidemiology
• Principles of pharmacoeconomic analysis
• Pharmaceutical Outcomes evaluations 

Module 15: Medical Device Clinical Trials (MDCTs)

• Medical Devices Rules, 2017
• Classification of Medical Devices
• Materiovigilance
• Phases of Medical Device Clinical Trials

Module 16: Medical Writing (Protocol, ICD, CRF, CSR) for Clinical Trial and Regulatory Submission

• Case reports
• Article writing
• Designing Clinical Trial protocol
• CRF Designing
• Informed Consent Documents
• Clinical Study Reports 

Module 17: Virtual Clinical Trial (Role of Artificial Intelligence (AI) and Machine Learning (ML))

• E-Consent (Audio visual consent)
• E-Patient Reported Outcomes (e-PRO)
• IWRS
• Telemedicine
• Patient e Diaries
• Remote Patient Monitoring 

Module 18: Clinical Trial- Latest Updates

• ICH-GCP_E6 R3
• NDCT Rules: 2019 & its Amendment (2023)
• ICMR-HMSC
• Recent CDSCO Notices
• NABH Ethics Committee Standards, etc.) 

Module 19: Industry Based 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 duration to complete this programme is 1 year (Post Graduate Diploma), 6 months (Executive Diploma).

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

A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

• Assignments for all the programme modules for continuous evaluation and guidance.
• Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
• Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination
• 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.

Examination and Certification

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. This programme is approved by Quality Council of India (QCI), Government of India

All the participants are obliged to timely submit completed assessment assignments (during the programme, usually after every module) and appear for an online exam at the end of the programme. After successful completion, the participants will receive a certificate of Post Graduate Diploma/Executive Diploma in Clinical Research by Faculty of Clinical Research, IGMPI. For all the above-mentioned modules, Online Classes (Online mode) or face-to-face classes (Regular mode), elaborate programme material, self-assessment assignments would be provided by the Institute. Details get updated on the webpage as well.

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 like IQVIA, Parexel, Syneos Health, Fisher Clinical Services, Dr. Reddy’s Laboratories, Divi’s Laboratories, GVK Biosciences, Avra Labs, SRL Ranbaxy, Torrent Pharmaceutical Ltd., Novartis Life Sciences, Jubilant Lifesciences Ltd., Aurobindo Pharmaceuticals Ltd., Venus Remedies Ltd., 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

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 programme 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 programme 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.