6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week
At the heart of research and development are the domains of drug safety and regulatory affairs which are crucial for successful and efficient product development. This unique program provides you an opportunity to explore them both.
TOTAL CREDITS: 32
Next Start Date
Why study this program?
Pharmacovigilance is an area of scientific research that principally deals with determining, confirming, quantifying, examining and lowering the side effects of drugs, medical devices and other medical treatments available in the market, thus making them more safe for human use.
Pharmacovigilance plays a pivotal role right from the time the new drug is tested in humans until the drug remains available in the market.
With the worldwide economic shift and the capabilities demonstrated by developing economies like India, China, Brazil and Russia, the pharma biotech companies are gradually shifting their R&D and pharmacovigilance work to these countries, the primary reasons being lower operating costs and availability, skilled workforce and compliance to international regulations.
Also at the heart of research and development is the domain of drug regulatory affairs which is crucial for successful and efficient product development. Regulatory Affairs professionals provide expert advice about applicable local and international regulations related to drug and device development, suggest best possible regulatory pathways for development of each product and thus help the research teams work more efficiently.
In the modern day pharma-biotech scenario in which companies are strongly competing with each other to be innovative and develop better products, workforce with formal training in pharmacovigilance and drug regulatory affairs play a critical role. Experienced regulatory affairs professionals lead large scale multi-national projects and ensure that clinical trials and marketing activities are conducted strictly according to the applicable regulatory requirements of each country.
What will be taught?
MODULE 01: GENERAL INTRODUCTION
MODULE 02: EPIDEMIOLOGY AND EVIDENCE BASED MEDICINE
MODULE 03: PRINCIPLES OF PHARMACOVIGILANCE
MODULE 04: PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES
MODULE 05: PHARMACOVIGILANCE SYSTEMS
MODULE 06: GLOBAL PHARMACOVIGILANCE AND SAFETY STANDARDS
MODULE 07: PHARMACOVIGILANCE REGULATIONS & GUIDELINES
MODULE 08: PHARMACOEPIDEMIOLOGY
MODULE 09: INTRODUCTION TO THE JUDICIAL SYSTEM IN INDIA
MODULE 10: DRUGS AND COSMETIC ACT AND RULES
MODULE 11: SCHEDULE Y
MODULE 12: INDIAN REGULATIONS GOVERNING CLINICAL TRIALS
MODULE 13: REGULATORY REGIME IN US
MODULE 14: EUROPEAN MEDICINES AGENCY (EMEA)
MODULE 15: REGULATIONS IN JAPAN
MODULE 16: IN-VITRO & IN-VIVO PRE-CLINICAL STUDIES
MODULE 17: EFFICACY TOPICS RELATED TO CLINICAL STUDIES
MODULE 18: COMMON TECHNICAL DOCUMENT (CTD)
MODULE 19: IND & NDA REQUIREMENTS
MODULE 20: CMC INFORMATION
MODULE 21: OVERVIEW OF GHTF
MODULE 22: REGULATORY PROCESSES FOR MEDICAL DEVICES AND VETERINARY PRODUCTS
MODULE 23: BIOSIMILARS EMEA GUIDANCE AND REGULATIONS
MODULE 24: BIOPHARMACEUTICAL INDIAN REGULATIONS AND GUIDELINES
MODULE 25: REGULATORY STRATEGIC PLANNING, INTERFACING & CORPORATE COMMUNICATIONS
TOTAL CREDITS: 32
MODE OF STUDY: ONLINE
The curriculum for the program - Advanced Post Graduate Diploma in Pharmacovigilance & Regulatory Affairs (APGDP-RA) is robust, has been developed and evaluated by seasoned pharmacovigilance and regulatory affairs professionals and is fully endorsed by the industry. This online training program is recommended for fresh graduates as well as for working professionals who wish to grow further in their pharmacovigilance and/or regulatory affairs career. It is also suitable for those who wish to shift to the pharmacovigilance or regulatory affairs sector from any other related industry.
How will I be assessed?
You will be assessed on an ongoing basis by the faculty based on the following criteria:
One is the completion of the online multiple choice question tests that follow each lesson; and second is the timely submission of assignments for each study module within the JLI e-Campus.
Your academic performance in the program will be assessed on a 4 point GPA scale. More details about our evaluation system is available in the following link: Evaluation System
Am I eligible?
The minimum eligibility criteria for Advanced Post-Graduate Diploma in Pharmacovigilance & Regulatory Affairs (APGDP-RA) would include either of the following:
- Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
- Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
- Any degree in Pharmacy / Pharmaceutical Sciences
- Any degree in Chemistry / Biostatistics / Bioinformatics
- Any degree in Nursing / Allied Health.
- Students in their final year of graduation for the above courses are also eligible to apply.
Candidates without any science background or candidates with some work experience in drug safety/ regulatory affairs / allied areas may also be eligible for this program. Please contact our counsellors to discuss your case.
What support will I receive?
As a student you can interact online with the faculty members and fellow students to network and to discuss important topics via your e-Campus. The faculty promptly answers all questions related to the study in the Online Campus Tutoring Center (OCTC).
Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.
In addition, each participant registered in the Advanced Post-Graduate Diploma in Pharmacovigilance & Regulatory Affairs course is provided with a mentor who is an experienced industry professional. The mentor can be contacted at any time via email or phone.
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James Lind Institute offers various masters degree programs in the areas of public health, business administration etc.
- MPH (with specializations)
- M.Sc in Health Mgmt
- MBA (various specializations)
For information on available masters programs via our School of Health Sciences; & our Business School click below:
According to a report by Cutting Edgeinfo there is a widening talent gap in Regulatory Affairs departments which is a problem for small pharma. Trained Regulatory Affairs Professionals are highly sought after.