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 Commencement Date
Why study this program?
Clinical research is a highly dynamic and vital discipline addressing to the need of evaluating new treatments in an ethical manner. A recent recognition of diversity in inter-individual and interracial gene pools along with an age old cultural diversity makes it more challenging. Progress towards the concept of building personalized medicines is giving a new shape to the whole pharmaceutical research and development industry.
Central to this scientific discipline is the domain of regulatory affairs which forms a web of standardized laws and conventions striking a balance between facilitation of innovation and safety of clinical research subjects.
In today’s clinical research environment, regulatory affairs professionals spearhead the multinational projects and ensure that trials are conducted in accordance to the regulatory requirements of the sponsor’s country as well as the country hosting the study.
We at the James Lind Institute develop students interested in regulatory affairs into accomplished professionals abreast with the latest knowledge required. The APGDCR-RA course is practically oriented and based on the tasks expected of a regulatory affairs expert in the clinical research industry. Students enrolled for the APGDCR-RA course are provided with the knowledge of the worldwide regulatory framework and develop skills required for regulatory strategic planning throughout the product lifecycle. Students in this course learn the methods of critical evaluation for risk/benefit analysis by analyzing the economic, societal, regulatory and corporate demands. Students also gain the knowledge necessary for working in an advisory position as a regulatory affairs expert for pre and post marketing projects. Further students in this course are taught to interface with the regulatory authorities and clinical research stakeholders for facilitation of 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?
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 Post-Graduate Diploma in Clinical Research & Regulatory Affairs Course (APGDCR-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”.
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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.