PG Diploma in Clinical Trial Management and Regulatory Affairs - Course, Syllabus, Fees, Colleges, Scope

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.

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.

Highlights: PGD in Clinical Trial Management and Regulatory Affairs

PGD in Clinical Trial Management and Regulatory Affairs Eligibility Criteria

For admission to the PG Diploma in Clinical Trial Management and Regulatory Affairs, different colleges accept students based on the following criteria:

• Candidates should be graduates in health sciences/ pharmacy/ basic sciences/ nursing or any equivalent degree like BPharm MBBS or Bachelor's Degree with two years of experience in the Pharmaceutical Industry.

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.

• 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.

• The applicants will have to submit their documents for verification by the college authorities to be considered eligible for the course.

• Applicants must go through the eligibility criteria and the instructions given by the respective college or institute before applying.

• Most of the institutes conduct online admissions, which makes it relatively easy for candidates to complete the procedure.

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.

Skills Required for PGD in Clinical Trial Management and Regulatory Affairs

PGD in Clinical Trial Management and Regulatory Affairs course requires the candidates to have certain skills to perform well academically and professionally in their careers. To pursue a PGD in Clinical Trial Management and Regulatory Affairs one must be skilled in certain areas so that the learning could be easier. Some of the skills that one must have are mentioned below:

• Logic

• Patience

• People skills

• Analytical skills

• Critical Thinking

• Communication skills

• Problem-solving skills

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.

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, Biostatisticians, and 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 someone who helps people with their medical problems by coordinating appropriate research and medical trials so that standard medicine can be developed for a particular disease.

Top Recruiters

• Pfizer India Ltd.

• Johnson and Johnson Pharmaceutical Research and Development

• GlaxoSmithKline Pharmaceuticals Ltd.

• Cognizant Technologies

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.

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.

Source: Glassdoor

Note: The salary may vary depending on various circumstances.

Top PGD in Clinical Trial Management and Regulatory Affairs Colleges in India

There is only one college that offers a PG Diploma in Clinical Trial Management and Regulatory Affairs. It is a full-time one-year course offered at National College, Tiruchirappalli.