The Faculty of Clinical Research and Drug Safety (FCRDS) has been established as a constituent faculty of ‘Institute of Good Manufacturing Practices India’ (IGMPI), registered as a non-profit society (under The Societies Registration Act, 1860) with Government of India and a member (as a higher/professional Education Institute) of Quality Council of India(QCI) which is an autonomous body and an accreditation authority for education & vocational training providers under the Ministry of Commerce & Industry, Government of India. The FCR is dedicated to provide an easy to comprehend platform for education, training and exchange of information for clinical research professionals thereby fostering professional excellence in designing and execution of clinical research with expanding the knowledge base in core areas such as in clinical research, medical writing, pharmacovigilance and drug discovery and development.
India is fast becoming the preferred destination for clinical research for MNCs owing to relatively low cost of manpower, IT strengths in data management, qualified pharma professionals in drug discovery and development, pool of qualified doctors in medical writing, pharmacovigilence and overall study conduct, conformity to quality guidelines and high incidence of infectious and lifestyle diseases. Clinical trial industry is projected to become one billion dollar revenue industry as per Mckinsey report 2007.India is set to grab clinical research business over double the current level by 2016 as per international business and research consultancy firm Frost and Sullivan.
However there is enormous crunch of technical personnel with specific skills to match the requirements of this vast growing clinical research industry and pharmaceutical R&D as revealed in different surveys. The need of the day is to generate quality work force to cater to the needs of the clinical research industry and pharmaceutical R&D sector at various tiers.
The Faculty of Clinical Research and Drug Safety (FCRDS) is dedicated for providing education and training, news updates through newsletters covering national and international news and analysis on all aspects of drug discovery and development, clinical research, medical writing and pharmacovigilence. FCR is guided by brilliant, dynamic faculty members trained in various top CROs, SMOs and pharmaceutical industries possessing cutting edge technical expertise/skills and dedicated to teaching and research allowing new industry integrated programmes in drug discovery and development, clinical research, medical writing and pharmacovigilence.
The FCRDS team of technological experts has launched a high profile multi-tiered program to cater to the needs of knowledge intensive biotech /biopharma/ health care industry at different levels of employment, as well as that of academics. The FCR team of technology experts and other Industry advisors together pursue to make knowledge in drug discovery and development, clinical research knowledge, medical writing and pharmacovigilance training in the area of Pharma and healthcare easily accessible, through this platform.
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.
IGMPI is recognized by the Ministry of Commerce & Industry, Government of India and duly licensed and certified by Bureau of Indian Standards (BIS) under Bureau of Indian Standards (Conformity Assessment) Regulations 2018 (License number: ERO/EOMSM/L-8000027) for offering education and training programmes, services and processes in the areas of Pharmaceutical, Food, Nutrition, Healthcare, Environment Health & Safety (EHS), Environmental Social & Governance (ESG) and Marketing Communications.
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:
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.
IGMPI is a Lifetime Institutional member of Indian Pharmaceutical Association (IPA).
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 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.
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.
The programme is meant for all those keen on being a part of Medical writing industry, so all graduates, post graduates and even working professionals can apply for the programme and affirm a strong position in the industry. The field might sound lucrative for non-medical background personnel as well but should have passion to write. Even retired doctors™ have been seen showing interest in the field and could opt for the programme to get better accustomed with the tools used.
Writing skills get better with practice and so does medical writing. The zeal to explore varied fragments of the industry and availability to do research on new techniques, treatment methods and other progresses in the healthcare industry suffice to keep the medical writer winning in the industry. It is not at a monotonous industry or work type. Regular research work about progresses in the industry is a must and thus adventurous nature would suit a medical writer.
All the technical aspects of medical writing are made clear during the programme. IGMPI makes available this medical writing programme as an online programme and thus the benefits it entails within are numerous. Like:
Module 1: Introduction to Medical Writing
Module 2: Competency Model for Medical Writers
Module 3: Medical Terminologies
Module 4: Content research, writing techniques and reference styles
Module 5: Basics of Biostatistics
Module 6: Scientific Writing
Module 7: Medical Writing for Clinical Research Industry
Module 8: Ethics and Ethical Guidelines for Clinical Trials and Good Clinical Practices (GCP)
Module 9: Clinical Trials -Latest updates (New Drugs and Clinical Trials Rules 2019 and new amendments)
Module 10: Regulatory Writing (IND, NDA, ANDA, BLA, PMA)
Module 11: Dossier preparation in CTD Format, eCTD Submissions
Module 12: Standardization templates for regulatory submissions
Module 13: Medico Marketing
Module 14: Digital Medical Writing
Module 15: Achieving Flow and Cohesiveness
Module 16: Managing the Review Process (Quality Control Check/Proof Reading Concept)
Module 17: Plagiarism and Copyright
Module 18: Industry Based Case Studies
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.
The duration to complete this programme is 1 year (Post Graduate Diploma), 6 months (Executive Diploma), 3-4 months (Industry Certificate).
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.
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.
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 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/Industry Certificate in Medical Writing, 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.
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 healthcare like HCL Technologies, Syneos Health, Tata Consultancy Services, Parexel, Novartis, Labcorp, Indegene, Cognizant Technology Solutions, IQVIA, Quintiles Research (India) Private Limited, UDG Healthcare, GlaxoSmithKline, Pfizer, Sun Pharmaceuticals, Eli Lilly and Company, Sanofi, Novo Nordisk, Thermo Fisher Scientific, Accenture, Baxter International, Unichem Laboratories Limited, 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.
IGMPI offers placement assistance to its students. The Institute has partnered with many organizations for providing placement assistance to its participants. Besides, it has a robust placement cell comprising senior level Human Resources professionals and Talent Acquisition experts which maintain close links with business industry. This cell is continuously engaged in promoting employability of our participants. The efforts of our placement cell also include helping with professional resume writing while also assisting them to polish their interview & soft skills.
There is a vast scope of medical writing in various types of companies and sectors like in biotechnology, pharmaceutical and other healthcare-related companies. A medical writer can work in a medical communications firm and can contribute in the creation of pharmaceutical/healthcare educational programs. In any such company, scientific medical writer can be undertaken for the purpose of preparation of clinical and pre-clinical manuscripts, abstracts, articles, posters, clinical trial reports, and medical education materials. The scientific medical writers also have scope in the biotechnology industry and are responsible for editing and re-writing scientific papers amd granting applications, and for providing education and training to staff in scientific writing and editing.
For further enquiries:
Write to :
info@igmpi.ac.in
Faculty of Clinical Research and Drug Safety (FCRDS)
18001031071 (Toll Free), Phone: +91 11 26512850
C-6, Qutab Institutional Area, Near Old JNU Campus, New Delhi-110016
18001031071 (Toll Free), Phone: +91 11 26512850