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 Pharmacovigilance

With emphasis on Pharmacovigilance and Pharmacoepidemiology there appears huge need for adequately qualified and trained professional who could understand and take up post marketing surveillance roles in drug companies. Thus, there occurs a need of team of drug safety officers. Clearly this need is proportional to the number of new drugs being launched every year which is always increasing. IGMPI has stepped forward to tap this growing need as a professional opportunity for those keen for entering this industry by providing innovative regular and web-based education & training offer in Pharmacovigilance. This programme is being noticed and recognized worldwide* as an excellent means to get medicines related jobs.

The Post Graduate Diploma/Executive Diploma in Pharmacovigilance 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/Executive Diploma Programme is to familiarize the participant with the updated theoretical and practical aspects of the Pharmacovigilance. The diploma programme has the following tempting features which are definite to benefit one to all participants of the programme.

• Better industrial training and skills
• Better knowledge of the industry by making the trainees familiar and able to understand the main epidemiological and statistical principles, concepts and tools that are used in pharmacovigilance practices and research
• Practical and professional training about the Industry regulations and work processes and
• Good hold on the framework of PV industry leading to availability of best employment options
• To master basics concepts on how to communicate written and oral scientific results 

Programme Modules

Module 1: Introduction to Pharmacology, Clinical Trials, Pharmacovigilance and Pharmacoepidemiology

• Basics of Pharmacology
• The Clinical Research Industry
• Phases of Clinical Trials
• Pharmacovigilance methods
• Clinical Application of Pharmacoepidemiology

Module 2: Adverse Drug Reactions and Safety Reports

• Difference between Adverse Event and Adverse Drug Reaction
• Classification of ADR
• SAE Reporting
• Side effects and medication errors 

Module 3: Methodologies and Benefit assessment of medicines in Pharmacovigilance

• Passive Reporting- Spontaneous reports and case series
• Active surveillance
• Targeted Clinical Investigations
• Descriptive Studies 

Module 4: Management Systems and Drug Dictionaries in Pharmacovigilance

• Argus
• ArisG
• MedWatch
• MedRA
• WHODD

Module 5: Seriousness & Expectedness & Causality Assessment Criteria

• Expectedness Assessment
• Causality Assessment
• Naranjo Algorithm
• Hill’s Criteria

Module 6: Aggregate Safety Reports and Risk identification and assessment

• Development Safety Update Report (DSUR)
• Periodic Adverse Drug Experience Report (PADER)
• Periodic Benefit Risk Evaluation Report (PBRER)
• Periodic Safety Update Report (PSUR) 

Module 7: Pharmacovigilance Regulatory effects and Medicines risk communication in Various Countries

• CDSCO, India
• FDA, USA
• EMEA, Europe
• MHRA, UK
• TGA, Australia 

Module 8: Pharmacovigilance Programme in India (PVPI)

• Services of Indian Pharmacopoeia Commission (IPC)
• Adverse drug reaction (ADR) reporting in India
• Pharmacovigilance System Master File & capacity building
• Recent developments and future perspectives 

Module 9: Materiovigilance across the Globe

• Materiovigilance Program Of India
• Medical Device vigilance in US, FDA
• Guidance for manufacturers on vigilance in UK, MHRA
• Materiovigilance services across EU and non-EU countries 

Module 10: Signal Detection and Data Mining

• Data Sources for Signal Detection
• Tools for signal detection
• Data mining- statistical techniques
• Data mining methodologies 

Module 11: Pharmacovigilance of Herbal Drugs

• Need of pharmacovigilance in herbals
• Herbals concept of adverse effect
• Pharmacovigilance of herbal medicines: Current state and future directions
• Challenges in Herbal Drugs Pharmacovigilance 

Module 12: Pharmacovigilance Compliance and Inspections

• Good pharmacovigilance practices
• Coordination of pharmacovigilance inspections
• Guidelines on PV Inspections (NMRA)
• Pharmacovigilance Audits & Regulatory Inspections and Common Findings

Module 13: Training on Argus, ArisGlobal, ABcube etc software platforms

• Argus
• ArisGlobal
• ABcube

Module 14: Industry Based Case Studies

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. 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 Pharmacovigilance, IGMPI. For all the above-mentioned modules, Online Classes (Online mode) or face-to-face classes (Regular mode), elaborate programmes 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 Novartis, Paraxel, Makrocare, Genpact, Biocon, Wipro, TCS, Abbott, Apcerlife Sciences, Jubilant Life Sciences, Biosys, Quantum Solutions, Wockhardt, WNS, GVK, Merck Group, Sun Pharmaceuticals Ltd., Siroclin Pharm, IQVIA, Glenmark, Cipla Ltd., Macleods, Rhyme Life Sciences, IPCA Laboratories, Flamingo Pharma, Alembic, Cognizant Technology, Johnson & Johnson, Spectrum Pharmaceuticals, Torrent Pharmaceuticals Ltd., Zydus Cadila, Unichem Laboratories, Reliance Life Sciences, 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 Pharmacovigilance thus opening doors for entry into the industry. PG diploma in PV 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 have sustained growth in the industry.

Post Graduate Diploma/Executive Diploma in Pharmacovigilance is a comprehensive programme offering candidate with knowledge and practically important information about the industry type, working modalities, methodology used, techniques of quality control, drug development precisely but whole emphasis remains on Pharmacovigilance. This includes in depth study of varied types of adverse effects, serious adverse effect, adverse effect reporting regulation, documentation methods etc. 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 theoretical and practical facts about post marketing surveillance, candidate feels comfortable and confident when working in the industry. Obviously experience has no match and thus efforts are made to bring in experienced professionals to present projects, take lectures and thus add to the benefits reaped from the programme. Same is true for the professionals who are already a part of the CR industry but are keen on making lateral movement in their company by shifting to other Pharmacovigilance Department.

Pharmacovigilance involves activities related to understanding assessment, detection and prevention of adverse effects or any other drug-related problems Pharmacovigilance is a continuous process accepted for safety evaluation accompanied by steps to improve safe usage of medicines. Some of the job profiles related to the pharmacovigilance : Pharmacovigilance Expert, Drug Safety Associate, Clinical Operations,Drug Safety Specialist