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 Commencement Date
Why study this program?
Pharmaceutical Regulatory Affairs is considered to be a crucial department within the pharmaceutical companies, mainly because they deal with new clinical trial applications, new product marketing applications and regularly interact with the regulatory agencies to ensure that the company is compliant to applicable regulations and is fulfilling all its regulatory obligations. There are many regulations in place so that manufacturing pharmaceutical products, veterinary medicines, therapeutic devices, and many others is effective so as to be able to provide sustainable healthcare to individuals. A pre-requisite of pharma regulatory affairs as a profession is to possess thorough knowledge of all the major regulatory authorities such as the US FDA, EMA, DCGI etc and a know how / training of working in compliance with their regulations.
As mentioned earlier, the department of regulatory affairs is most vital for any organization or firm in the business of healthcare, primarily pharmaceutical, biotechnology and contract research. Regulatory Affairs professionals work to effectively communicate between the company and the regulatory authorities to improve & integrate principles concerning the regulatory affairs and to submit pertinent applications in the form of dossiers. Regulatory professionals keenly participate in each phase of the drug and medical device development process & also work on its marketing approval. Regulatory professionals exercise excellence in quality to bring about useful drugs that have great potential for cure or prevention.
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?
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 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?
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 Professional Diploma in Pharmaceutical Regulatory Affairs Course (PDPRA) 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”.
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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.