4 - 6 Months (Self Paced)
Maximum Allowed Duration: 18 Months
Expected Effort: 10-15 hours/week
This program will provide you a thorough understanding of various regulatory agencies such as the US FDA, EMA, CDSCO; investigational and new drug applications; regulatory strategies and various other concepts.
TOTAL CREDITS: 18
Next Start Date
Why study this program?
The regulations related to the development, sale and marketing of healthcare products have seen stricter reforms over the last few decades. Regulatory authorities are being set up in an increasing number of nations throughout the globe. Those which are already set up are restructuring their regulations and trying to match with the regulatory authorities of other nations. The regulatory standards related to healthcare products has seen rapid advancement due to changes in product safety, regulatory compliance, technological transformation, enhanced understanding of disease characteristics and customer requirements.
The global regulatory affairs teams and regulatory specialists in the bio-pharmaceutical and medical devices sector occupy a main and vital role compared to all the other functional departments. Professionals working in regulatory affairs departments play a vital role in making sure that all bio-pharmaceutical products and medical devices developed by their organization are in compliance with regulations put forth by regulatory authorities.
Regulatory professionals do not just function in the initial application process, but also work in the licensing and marketing phases – ensuring that all procedures and products meet necessary safety and efficacy requirements.
Regulatory affairs professionals are in high demand and the career opportunities in this area are phenomenal. This program will provide you a thorough understanding of various regulatory agencies such as the US FDA, EMA, CDSCO; investigational and new drug applications; regulatory strategies and various other concepts.
What will be taught?
MODULE 01: GENERAL INTRODUCTION
MODULE 02: INTRODUCTION TO JUDICIAL SYSTEM IN INDIA, D&C ACT
MODULE 03: SCHEDULE Y
MODULE 04: INDIAN REGULATIONS GOVERNING CLINICAL TRIALS
MODULE 05: REGULATORY REGIME – FDA, EMA & JAPAN
MODULE 06: SAFETY TOPICS RELATED TO PRE-CLINICAL & CLINICAL STUDIES
MODULE 07: COMMON TECHNICAL DOCUMENT, IND & NDA REQUIREMENTS
MODULE 08: CMC INFORMATION & GHTF OVERVIEW
MODULE 09: MEDICAL DEVICES, VETERINARY PRODUCTS & BIOSIMILARS
MODULE 10: BIOPHARMACEUTICAL INDIAN REGULATIONS AND REGULATORY STRATEGIC PLANNING
TOTAL CREDITS: 18
MODE OF STUDY: ONLINE
The curriculum for the program - Professional Diploma in Pharmaceutical Regulatory Affairs (PDPRA) is extensive, has been developed and evaluated by experienced professionals and is fully endorsed by the pharmaceutical 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 Professional Diploma in Pharmaceutical Regulatory Affairs 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.
If you lack the above mentioned educational prerequisite you may still be eligible to apply if you have some prior work experience in clinical research / regulatory affairs / allied areas. Please contact our admission representatives / counsellor 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 Professional Diploma in Pharmaceutical Regulatory Affairs Course is provided with a mentor who is an experienced professional from the pharmaceutical industry. 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:
Regulatory affairs departments are the cornerstone of every organization that is involved in the clinical trial business. Regulatory affairs professionals provide valuable insight about how a new product can be marketed in compliance with all applicable regulations and guidelines. They are also the point of contact for regulatory authorities and help address any issues / concerns raised by the authority.