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PG Diploma in Clinical Trial Management and Regulatory Affairs - Course, Syllabus, Fees, Colleges, Scope
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PG Diploma in Clinical Trial Management and Regulatory Affairs is a full-time one-year course offered at various colleges and universities. It is designed to provide students with advanced education and training in regulatory sciences. Candidates who have passed undergraduate degrees such as BPharm, or MBBS from a recognised University can pursue this programme.
This Story also Contains
- NEET-PG Important Exam Dates
- PGD in Clinical Trial Management and Regulatory Affairs-Highlights
- PGD in Clinical Trial Management and Regulatory Affairs Eligibility Criteria
- PGD in Clinical Trial Management and Regulatory Affairs Admission Process
- PGD in Clinical Trial Management and Regulatory Affairs- Top Entrance Exam
- PGD in Clinical Trial Management and Regulatory Affairs Subjects/Syllabus
- Scope of PGD in Clinical Trial Management and Regulatory Affairs
- Career Options After PG Diploma in Clinical Trial Management and Regulatory Affairs
- Average Salary After PGD in Clinical Trial Management and Regulatory Affairs
- Top PGD in Clinical Trial Management and Regulatory Affairs Colleges in India
PG Diploma in Clinical Trial Management and Regulatory Affairs focuses on ensuring the safety and effectiveness of a wide range of products including pharmaceuticals and biopharmaceuticals. Students in this programme will learn about all aspects of drug development, approval, and marketing, and will gain a comprehensive understanding of the regulatory requirements that apply to these processes.
NEET-PG Important Exam Dates
NEET PG Admit Card has been released on 31st July 2025
NEET PG 2025 Exam Date – 3rd August 2025
PGD in Clinical Trial Management and Regulatory Affairs-Highlights
Particulars | Values |
|---|---|
Course Name | PG Diploma in Clinical Trial Management and Regulatory Affairs |
Course Duration | 1 year |
Examination Type | Semester wise |
Semesters | 2 semesters |
Eligibility Criteria | BPharm, MBBS |
Admission Process | Based on application |
Average Salary | Rs. 7.0 LPA |
Course Fees | Rs. 30,000 |
Top Companies | Pfizer India Ltd., Johnson and Johnson Pharmaceutical Research and Development, GlaxoSmithKline Pharmaceuticals Ltd., Cognizant Technologies |
Job Position | Regulatory Affairs Specialist, Clinical trial manager, Clinical Research Specialist |
PGD in Clinical Trial Management and Regulatory Affairs Eligibility Criteria
A Postgraduate Diploma (PGD) in Clinical Trial Management and Regulatory Affairs is a specialised programme designed for candidates aiming to build a career in clinical research, drug development, and regulatory frameworks. For admission to the PG Diploma in Clinical Trial Management and Regulatory Affairs, different colleges accept students based on the following criteria:
| Eligibility Criteria | Details |
|---|---|
| Educational Qualifications | Candidates must have a bachelor’s degree |
| Minimum Marks | A minimum of 50% marks or equivalent GPA in the qualifying degree |
| Work Experience | Some institutes may prefer or require 1–2 years of relevant work experience, especially for executive or weekend programs. |
| Entrance Exams | Some reputed institutions may conduct personal interviews or aptitude tests for admission |
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PGD in Clinical Trial Management and Regulatory Affairs Admission Process
For admission to the PG Diploma in Clinical Trial Management and Regulatory Affairs, the candidate has to complete the whole admission procedure. Candidates are advised to carefully follow the admission procedure for the PG Diploma in Clinical Trial Management and Regulatory Affairs.
Step 1- The basic admission process involves eligible candidates filling in the application form and registering for the course within the time slot provided by the college or university.
Step 2- The applicants will have to submit their documents for verification by the college authorities to be considered eligible for the course.
Step 3- Applicants must go through the eligibility criteria and the instructions given by the respective college or institute before applying.
Step 4- Most of the institutes conduct online admissions, which makes it relatively easy for candidates to complete the procedure.
PGD in Clinical Trial Management and Regulatory Affairs- Top Entrance Exam
NEET-PG is a national-level entrance examination conducted by the National Board of Examinations in Medical Sciences (NBEMS). It is required for admission to MD, MS, and PG Diploma courses in government and private medical colleges across India (except AIIMS, JIPMER, PGIMER, and NIMHANS, which accept INI-CET).
| Exam Name | Conducting Body | Exam Pattern |
|---|---|---|
National Board of Examinations (NBE) | ||
National Testing Agency | ||
AIIMS, New Delhi |
Cut-off Top Colleges
A cut-off score for a PG Diploma in Clinical Trial Management and Regulatory Affairs colleges is a set of criteria used to assess a student’s merit performance. The admission is done based on the candidate's score in MBBS or any equivalent degree like BPharm.
PGD in Clinical Trial Management and Regulatory Affairs Subjects/Syllabus
The subjects included in the course curriculum of the PG Diploma in Clinical Trial Management and Regulatory Affairs are divided into the following modules that are to be covered in the whole year of this diploma. For the candidate’s reference, we have mentioned the syllabus of the course for ICBio Institute of Clinical Research, Bengaluru.
| Semester 1 | Semester 2 |
|---|---|
Introduction to Clinical Research | Pharma Regulatory Affairs |
Guidelines, Regulations, and Ethics in Clinical Research | Clinical Trial Management |
Site Management Organisation | Clinical Trials Documents Management |
Perspective on Clinical Evaluation | Case Study |
Job Training/Minor project work- Viva | Dissertation work on ethics committee submission Viva Voce |
Scope of PGD in Clinical Trial Management and Regulatory Affairs
The scope of the PG Diploma in Clinical Trial Management and Regulatory Affairs offers students a promising future in the medical line. There is a high demand for specialists, and students after completing this course can pursue various roles.
After completing a PG Diploma in Clinical Trial Management and Regulatory Affairs, students can further go for higher education and take more diploma courses in related disciplines. It provides a pathway to a rewarding and impactful career such as Clinical trial manager, Biostatistician, and a data manager.
Career Options After PG Diploma in Clinical Trial Management and Regulatory Affairs
PG Diploma in Clinical Trial Management and Regulatory Affairs offers various job profiles to candidates. The following are some of the job profiles:
Data manager - Data Managers ensure the accuracy and completeness of clinical trial data. They make sure that all the details are put in and manage the data.
Clinical trial manager - Clinical Trial Managers coordinate all aspects of a clinical trial. They manage the clinical trials and ensure that trials are performed with accuracy.
Biostatisticians - Biostatisticians analyse clinical trial data to draw meaningful conclusions. They perform in-depth trials on statistical data.
Clinical Research Coordinator - Clinical research coordinators are people who help people with their medical problems by coordinating appropriate research and medical trials so that standard medicine can be developed for a particular disease.
Benefits of Studying PGD in Clinical Trial Management and Regulatory Affairs
PG Diploma in Clinical Trial Management and Regulatory Affairs aims to teach core concepts of clinical drug usage, drug development, and the pharma industry. It gives students an interdisciplinary understanding of pharmacy and law as it relates to national and international pharmaceutical regulation.
PG Diploma in Clinical Trial Management and Regulatory Affairs prepares students for careers in the pharmaceutical business, export-import companies that deal with pharmaceuticals, and drug licensing and control authorities.
Average Salary After PGD in Clinical Trial Management and Regulatory Affairs
Based on their region, job profile, and skill set, graduates with a postgraduate diploma in clinical trial management and regulatory affairs can expect to earn a certain salary.
Job Profiles | Average Salary |
|---|---|
Data Manager | Rs. 11 LPA |
Clinical Trial Manager | Rs. 13.25 LPA |
Biostatisticians | Rs. 4.67 LPA |
Clinical Research Coordinator | Rs. 4.5 LPA |
Source: Glassdoor
Note: The salary may vary depending on various circumstances.
Top Recruiters
- Pfizer India Ltd.
- Johnson and Johnson Pharmaceutical Research and Development
- GlaxoSmithKline Pharmaceuticals Ltd.
- Cognizant Technologies
Top PGD in Clinical Trial Management and Regulatory Affairs Colleges in India
The PG Diploma in Clinical Trial Management and Regulatory Affairs is a career-oriented program designed to provide in-depth knowledge of clinical research processes, ethical considerations, regulatory guidelines, and drug approval pathways. There is only few colleges that offer a PG Diploma in Clinical Trial Management and Regulatory Affairs. It is a full-time one-year course offered at
- Indian Institute of Clinical Research and Management, Maharashtra
- Jadavpur University, Kolkata
- National College, Tiruchirappalli
The PG Diploma in Clinical Trial Management and Regulatory Affairs is an ideal choice for graduates in life sciences, pharmacy, or healthcare who wish to enter the fast-growing field of clinical research and regulatory science. The programme not only equips students with the technical knowledge of clinical trials and global regulations but also opens doors to a range of career opportunities in pharma companies, CROs, and regulatory agencies.
Frequently Asked Questions (FAQs)
Q: What is the duration of a PG Diploma in Clinical Trial Management and Regulatory Affairs?
A:
PG Diploma in Clinical Trial Management and Regulatory Affairs is a full-time one-year course offered at colleges and universities.
Q: What is the admission procedure PG Diploma in Clinical Trial Management and Regulatory Affairs?
A:
The basic admission process involves eligible candidates filling in the application form and registering for the course within the time slot provided by the college or university.
Q: What is the scope of a PG Diploma in Clinical Trial Management and Regulatory Affairs?
A:
The PGD in Clinical Trial Management and Regulatory Affairs provides students with a bright future because a profession in medicine is consistently lucrative. Experts are highly sought after. Graduates can pursue higher education or a variety of roles.
Q: Which college offers a PG Diploma in Clinical Trial Management and Regulatory Affairs?
A:
PG Diploma in Clinical Trial Management and Regulatory Affairs is a full-time one-year course offered by the Bharathidasan University, Tiruchirappalli.
Q: What are the eligibility criteria for PG Diploma in Clinical Trial Management and Regulatory Affairs?
A:
Candidates should be graduates/ Post-graduate in health sciences/ pharmacy/ basic sciences/ nursing or any equivalent degree like BPharm MBBS or Bachelor Degree with two years experience in Pharmaceutical Industry.
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Questions related to B.Pharma
On Question asked by student community
Have a question related to B.Pharma ?
Hello,
If wants to apply for B.pharma in Delhi colleges . Many colleges accept students from other states through all India quota or management quota. Here’s how you can apply
1. IPU Guru Gobind Singh Indraprastha University
You can apply for BPharma through IPU CET or CUET UG (if they consider it). Keep checking the IPU admission website for updates.
2. Private Colleges in Delhi NCR:
Many private colleges like Jamia Hamdard, Amity University, and Delhi Institute of Pharmaceutical Sciences DIPSAR also accept students from outside Delhi. Some of them offer direct admission based on 12th marks or national entrance exams like CUET or GPAT (for PG).
3. Central Counselling : Some top-level institutes take students via centralized counselling, depending on the exam they accept, like CUET UG.
Make sure to check the eligibility, application dates, and whether the college has an all-India quota.
For more details about colleges in Delhi you can visit here :
https://pharmacy.careers360.com/colleges/list-of-pharmacy-colleges-in-delhi
Hope this helps! Good luck
If your interest is in Computer Science, then SRM AP-CSE is the better option for future scope and placements. VIT Bhopal CAE is good for core engineering, and BITS BPharma is best if you want a career in pharmacy. Choose based on your interest and career goal.
If your goal is to become a Clinical Research Associate (CRA), a B.Pharm is a highly relevant degree and a good stepping stone.
Many Clinical Research Associate positions require a bachelor's degree in a life science, such as Pharmacy, Nursing, or Biosciences.
Your B.Pharm coursework will provide you with a good understanding of pharmacology, drug development, and the regulatory aspects of pharmaceuticals, which are essential for clinical research.
To further enhance your chances of becoming a CRA, pursuing additional training or certification in clinical research, like a Post Graduate Diploma in Clinical Research (PGDCR), is highly recommended. These courses focus on industry-specific skills like clinical trial management, regulatory compliance (including ICH-GCP guidelines), and data analysis,.
Good luck!!
With a NEET score of 151 and 68 percentile in CET OBC category, you can try for B.Pharm admission in government colleges like
- ICT Mumbai
- Government College of Pharmacy (Aurangabad, Karad)
- DIPSAR Delhi.
Due to a technical issue or separate counselling, BPharma might not appear on the HPCET counselling portal.
Verify your eligibility and give it another go later.
If the issue persists, get in touch with HPTU.
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