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 Pharmacology

This Programme is devised with all intensive and comprehensive research to impart broad conceptual information to the students. You will gain better understanding of the effects of drugs on the human body.It equips a student with the ability to understand the major biochemical pathways that are activated when drugs interact with their respective receptors, the molecular mechanisms of drugs, significance of correct dosage, efficacy and safety of medicines and give broad work open doors by drug industry and agreement research associations in different regions like fundamental pharmacological exploration, toxicology, clinical pharmacology, Drug composition and their administration.

Programme Modules

Module 1: Human Anatomy and Physiology

• Cells & Tissue
• The Nervous System, The Endocrine System, The Cardiovascular System & The Lymphatic System
• The Respiratory System, The Digestive System & The Urinary System
• Reproductive System, The Muscular System & The Skeletal System 

Module 2: Cellular and Molecular Biology

• Introduction to Biomolecules (Nucleic Acids, Protein, Carbohydrates & Lipids)
• Receptors and their types
• Secondary Messengers and Secondary Signaling Pathways 

Module 3: Advance Pharmacology-1

• General Pharmacology
• Systemic Pharmacology
• CNS Pharmacology
• CVS Pharmacology
• Autocoid Pharmacology

Module 4: Advance Pharmacology-2

• Endocrine Pharmacology
• Chemotherapy
• Immunopharmacology
• GIT Pharmacology
• Free Radicals Pharmacology 

Module 5: Pharmacological and Toxicological Screening Methods

• General Principles of Screening and Animal Models
• Pharmacological Screening Models – Hypertension, Pain, Epilepsy, Depression, Ulcers, Ischemia, Alzheimer’s disease, Parkinson’s disease, Diabetes and Leishmaniasis.
• Regulatory Toxicology (OECD Test Guidelines: Acute, Sub-acute, Sub-chronic & Chronic, Reproductive Toxicity, Teratogenicity, Genotoxicity and Carcinogenicity 

Module 6: Experimental Pharmacology (using Ex. Pharm)

• Animal Handling and CPCSEA guidelines
• Computer Simulation and Toxicity tests 

Module 7: Drug Development Process

• Modern Drug Discovery System
• Target Identification and Validation
• Lead Identification and Validation
• Drug Design
• Molecular Docking 

Module 8: Pre-clinical Studies

• Animal Ethics
• Study Reports
• Hypothesis Creation 

Module 9: Clinical Research & Pharmacovigilance

• Clinical Trials
• Clinical Research Stakeholders and Core team
• Ethics in Clinical Research
• Pharmacovigilance
• Seriousness, Expectedness and Casualty Assessment of ADRs
• PvPI 

Module 10: 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 11: Pharmacoepidemiology, Pharmacoeconomics & Safety Pharmacology

• Pharmacoepidemiology- Methods
• Clinical Application of Pharmacoepidemiology
• Principles of Pharmacoeconomic analysis
• Pharmaceutical Outcomes evaluations
• Safety Pharmacology

Module 12: Research Methodology & Biostatistics

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

Module 13: Recent Advances in Pharmacology

• Advances in Drug Therapy
• Novel Drug Targets
• Neuropeptides 

Eligibility

BTech/Bsc in Biotechnology/ Microbiology/ Botany/ Zoology/ B.Pharm/M Pharm/MSc / MBBS/ BDS/ BHS/ BUMS/ BAMS/ Graduation in Life science disciplines are eligible for the programme.

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.

All the participants are expected to appear for an online exam and are also obliged to submit assignments after each module. After successful completion, the participants will be awarded Post Graduate Diploma/Executive Diploma in Pharmacology by IGMPI. For all the above mentioned modules elaborate programme material, self-assessment assignments and project work details would be provided by the Institute from time to time. 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. 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 giants like Mankind Pharma Ltd, GSK Ltd, Syngene International, Torrent Pharmaceuticals, Jubilant LifeSciences Ltd, Granules India Ltd, Dr Reddy’s Laboratories, IpcaLaboratories, Sun Pharma Ltd, Glenmark Generics, AurobindoPharma Ltd, Abbott Healthcare Pvt Ltd, CiplaLtd , NatcoPharma , Mylan Laboratories, Sciformix, Cognizant, Kinapse, Iqvia, iMed Global

Future career prospects

IGMPI offers proficient and industry oriented training in Pharmacology hence opening entryways for passage into the industry. Post Graduate Diploma/Executive Diploma in Pharmacology adds advantage for those Professionals who are already having an in hand experience in the industry as well concerning the individuals who are new to the industry. This Programme will help you in backing of apt and up-to-date information and training required to have sustained growth in the industry.

PG Diploma in Pharmacology is a thorough programme offering candidate with information and for all intents and practically important information about the sources, chemical properties, biological effects, molecular mechanisms and therapeutic uses of drugs. Pharmacologists are likewise associated with molecular modeling of drugs, and the use of drugs as tools to dissect aspects of cell function. The extent of pharmacology has extended dramatically in the programme of the last ten years to join many new methodologies, for example, such as computer-assisted drug design, genetic screens, protein engineering and the use of novel drug delivery vehicles including viruses and artificial cells. Pharmacologists can explore professions in Academia, Pharmaceutical Industries, Contract Research Organizations, and Drug Regulatory Agencies.