6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week
This practically driven training program is centered on the tasks expected of a regulatory affairs professional. You will understand the global regulatory structure, and acquire skills needed for regulatory strategic planning.
TOTAL CREDITS: 34
Next Start Date
Why study this program?
Clinical research is a rapidly progressing, essential field of medical science that deals with the evaluation of new medicines and therapies with an ethical approach. Developing these new medicines is very challenging considering the inter-individual, inter-racial and cultural diversities that we possess as human beings.
Advancement towards the idea of developing personalized treatments is giving a new dimension to the research and development efforts of the global drug development industry.
Fundamental to clinical research is the domain of regulatory affairs which forms a network of standardized laws, regulations and guidelines creating an equilibrium between facilitation of innovation and safety of subjects enrolled in clinical trials.
In the present global clinical research landscape, regulatory affairs professionals lead multinational assignments and make sure that clinical trials are performed in compliance to the applicable regulatory requirements of the sponsor’s nation as well as the international locations where the clinical trial is being conducted.
At JLI we strive to develop clinical research and regulatory affairs professionals who are equipped with the most relevant and up-to-date knowledge and skills. This Advanced Clinical Research and Regulatory Affairs training program is practically driven and centered on the tasks expected of a regulatory affairs professional in the clinical research industry. In this Regulatory Affairs training you are provided with the understanding of the global regulatory structure and acquire skills needed for regulatory strategic planning throughout the product lifecycle.
In this training course you will understand the techniques of critical evaluation for risk/benefit analysis by assessing the economic, societal, regulatory and corporate requirements. You will also attain the expertise essential for performing in an advisory role as a regulatory affairs specialist for pre and post marketing projects. Additionally, you will learn how to interface with the regulatory agencies and other key stakeholders for accomplishing regulatory compliance.
What will be taught?
MODULE 01: GENERAL INTRODUCTION
MODULE 02: EPIDEMIOLOGY & EVIDENCE BASED MEDICINE
MODULE 03: PHARMACEUTICAL MEDICINE
MODULE 04: THERAPEUTIC AREAS
MODULE 05: ETHICS IN CLINICAL RESEARCH
MODULE 06: ROLES AND RESPONSIBILITIES
MODULE 07: CLINICAL TRIAL PREPARATION
MODULE 08: ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 09: STUDY START-UP
MODULE 10: CLINICAL TRIALS MONITORING
MODULE 11: COMPLIANCE AND AUDITS
MODULE 12: DATA MANAGEMENT AND BIOSTATISTICS
MODULE 13: REGULATORY AFFAIRS IN CLINICAL RESEARCH
MODULE 14: MEDICAL DEVICE TRIALS
MODULE 15: PROJECT AND VENDOR MANAGEMENT
MODULE 16: FINANCIAL MANAGEMENT OF CLINICAL TRIALS
MODULE 17: PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS
MODULE 18: INTRODUCTION TO JUDICIAL SYSTEM IN INDIA, D&C ACT
MODULE 19: SCHEDULE Y
MODULE 20: INDIAN REGULATIONS GOVERNING CLINICAL TRIALS
MODULE 21: REGULATORY REGIME – FDA, EMA, JAPAN, SINGAPORE
MODULE 22: SAFETY TOPICS RELATED TO PRE-CLINICAL & CLINICAL STUDIES
MODULE 23: COMMON TECHNICAL DOCUMENT, IND & NDA REQUIREMENTS
MODULE 24: CMC INFORMATION & GHTF OVERVIEW
MODULE 25: MEDICAL DEVICES, VETERINARY PRODUCTS & BIOSIMILARS
MODULE 26: BIOPHARMACEUTICAL INDIAN REGULATIONS AND REGULATORY STRATEGIC PLANNING
TOTAL CREDITS: 34
MODE OF STUDY: ONLINE
The curriculum for the program - Advanced Post Graduate Diploma in Clinical Research & Regulatory Affairs (APGDCR-RA) is comprehensive, has been developed and evaluated by experienced pharmaceutical regulatory affairs professionals and is fully endorsed by the clinical research 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 clinical research and/or regulatory affairs career, or those who wish to make a move to the clinical research or pharmaceutical regulatory affairs 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 Clinical Research & Regulatory Affairs (APGDCR-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 the clinical research / pharmaceutical industry / 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 Clinical Research & Regulatory Affairs Course is provided with a mentor who is an experienced professional from the clinical research 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 will prepare you to explore clinical research job opportunities such as clinical research coordinator, clinical research associate, clinical trial manager as well as jobs that are specific to regulatory affairs such as Regulatory Affairs Executive / Associate / Manager etc.
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 the need of the hour.