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 Commencement Date
Why study this program?
Pharmacovigilance is a field of science that primarily deals with determining, verifying, quantifying, analyzing and reducing the ill effects of medical drugs, devices or biologicals, thus increasing their safety.
Pharmacovigilance is an anchor throughout the life cycle of new drugs and devices due to a demand created by the requirement of new medical treatments and their legislation.
With the global financial drift and the promise shown by emerging nations such as India, China, Brazil and Russia, the drug development industry is moving its R & D and pharmacovigilance activities towards these regions for better efficiency and cost savings.
At the core of clinical research and pharmacovigilance is the area of regulatory affairs. Regulatory Affairs teams are well aware about local and international regulations pertaining to research activities, marketing of drugs etc and help facilitate innovation and reducing the time to market of promising new therapies.
In today’s drug development landscape with fierce competition among pharmaceutical companies, people with formal training in regulatory affairs spearhead large global projects from a regulatory perspective and make sure that studies are carried out as per the applicable regulatory requirements.
At James Lind Institute we transform students interested in pharmacovigilance & regulatory affairs into seasoned professionals up-to-date with the most recent knowledge and trends. The Advanced PG Diploma in Pharmacovigilance and Regulatory Affairs course is practically driven and structured on the responsibilities expected of a pharmacovigilance & a regulatory affairs professional in the drug development industry. Candidates enrolled in this highly focused pharmacovigilance and regulatory affairs program are equipped with the knowledge of the global regulatory landscape and acquire skills necessary for regulatory strategic planning throughout the product life cycle.
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?
Course assessment involves online multiple choice questions for each lecture, followed by assignments for each study module.
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?
Throughout the course, the students can interact with the faculty and other students via the e-Campus to discuss any coursework related issues.
Each student enrolled in the Advanced PG Diploma in Pharmacovigilance & Regulatory Affairs (APGDPV-RA) is also assigned a mentor throughout the course who will be a senior professional from the industry. Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.
Enter your email id and we will instantly send you more information about this program
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.