6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week
Regulatory affairs & Quality Assurance are both crucial aspects of clinical trials & overall drug development. They are pillars of safe and effective drug development. This program provides you an opportunity to explore both these areas.
TOTAL CREDITS: 32
Next Start Date
Why study this program?
The domain of regulatory affairs has grown tremendously in the last few decades. This growth is mainly due to increasing focus on the safety and effectiveness of drugs that come into the market. The growth of this sector is also due to the increasing research and development that keeps taking place in the industry. Evolving technologies and new research findings etc all call for more stringent regulatory oversight. Various steps have been taken by regulatory agencies around the world to simplify the processes for regulatory submissions and drug approvals. The sector now offers exciting career opportunities across the pharmaceutical industry, contract research organizations, regulatory consulting agencies, government agencies among many others.
Quality Assurance (QA) on the other hand is also a crucial cornerstone of the whole drug development process. QA departments make sure that the organization is compliant to the regulatory requirements and that it is following its Quality Control (QC) measures in all the tasks that it performs. QA departments help standardize each step of the clinical trial process. They make sure that the clinical trials are compliant to the organization's standard operating procedures, applicable regulations as well as guidelines. The QA department also usually conduct training sessions for their employees. Overall QA is a challenging function and offers excellent career opportunities and growth as well. This Advanced Regulatory Affairs and Quality Assurance Training Program has been conceptualized and designed to meet the growing demand of the industry for professionals with regulatory affairs and/or quality assurance training.
This program provides students the knowledge of all important quality assurance methods, processes and practices. It allows students to build a strong groundwork in the regulatory standards and aids to develop advanced skills and proficiency to create, manage and maintain quality systems and quality results.
What will be taught?
MODULE 01: GENERAL INTRODUCTION
MODULE 02: BASICS OF DRUG DEVELOPMENT
MODULE 03: INTRODUCTION TO JUDICIAL SYSTEM IN INDIA, D&C ACT
MODULE 04: SCHEDULE Y
MODULE 05: INDIAN REGULATIONS GOVERNING CLINICAL TRIALS
MODULE 06: REGULATORY REGIME – FDA, EMA & JAPAN
MODULE 07: SAFETY TOPICS RELATED TO PRE-CLINICAL & CLINICAL STUDIES
MODULE 08: COMMON TECHNICAL DOCUMENT, IND & NDA REQUIREMENTS
MODULE 09: CMC INFORMATION & GHTF OVERVIEW
MODULE 10: MEDICAL DEVICES, VETERINARY PRODUCTS & BIOSIMILARS
MODULE 11: BIOPHARMACEUTICAL INDIAN REGULATIONS AND REGULATORY STRATEGIC PLANNING
MODULE 12: QUALITY & QUALITY MANAGEMENT
MODULE 13: THE QUALITY ASSURANCE FUNCTION
MODULE 14: AUDITS
MODULE 15: QUALITY GUIDELINES
MODULE 16: GCP/GMP/GLP
TOTAL CREDITS: 32
MODE OF STUDY: ONLINE
The curriculum for the program - Advanced Post Graduate Diploma in Regulatory Affairs & Quality Assurance (APGDRA-QA) is comprehensive and has been developed and evaluated by experienced regulatory affairs and quality assurance professionals. It is fully endorsed by the industry. Not only is this online training course suitable for new graduates but also for working professionals who either wish to grow further in their regulatory affairs and/or quality assurance career, or those who wish to make a move to the regulatory affairs or clinical quality assurance domain 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 Regulatory Affairs & Quality Assurance (APGDRA-QA) 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 who have work experience in the pharmaceutical industry / quality assurance / regulatory affairs / allied areas may also be eligible for this program. Please discuss your case with our counsellors.
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 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 Regulatory Affairs and Quality Assurance Course is provided with a mentor who is an experienced professional from the 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:
This unique program allows you to explore positions such as Regulatory Affairs Executive, Regulatory Affairs Manager, Regulatory Affairs Associate etc. as well as Quality Assurance related roles such as Quality Assurance Associate, Quality Assurance Executive, Quality Auditor, QA Manager among many others.
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.