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

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

Edited By Team Careers360 | Updated on May 11, 2024 01:09 PM IST | #B.Pharma

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

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

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.

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, 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.

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 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.

Frequently Asked Questions (FAQs)

1. What are the eligibility criteria for PG Diploma in Clinical Trial Management and Regulatory Affairs?

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.

2. What is the admission procedure 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.

3. What is the scope of a PG Diploma in Clinical Trial Management and Regulatory Affairs?

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.

4. Which college offers a PG Diploma in Clinical Trial Management and Regulatory Affairs?

PG Diploma in Clinical Trial Management and Regulatory Affairs is a full-time one-year course offered by the Bharathidasan University, Tiruchirappalli.

5. What is the duration of a PG Diploma in Clinical Trial Management and Regulatory Affairs?

PG Diploma in Clinical Trial Management and Regulatory Affairs is a full-time one-year course offered at colleges and universities.

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Questions related to B.Pharma

Have a question related to B.Pharma ?

Hi,

To work abroad as a Pharm.D graduate from India, here are some general steps and considerations:

  1. Evaluation of Qualifications : First, ensure that your Pharm.D degree from India is recognized and meets the qualifications required in the country where you intend to work. This might involve getting your qualifications evaluated by professional bodies or educational institutions in the target country.

  2. Licensing and Registration : Most countries require pharmacists to be licensed or registered with their respective regulatory bodies. Research the licensing requirements of the country you are interested in, which may include passing exams or assessments specific to that country.

  3. Language Proficiency : Depending on the country, you may need to demonstrate proficiency in the local language, especially if patient interaction is part of the job.

  4. Work Experience : Some countries may require work experience or internship hours in addition to your degree. Gain relevant experience in India or through internships that align with international standards.

  5. Job Search : Research job opportunities through international job portals, pharmaceutical companies with global operations, or through networking with professionals in the field.

  6. Entrance Exams or Assessments : While specific entrance exams for pharmacists may not be common globally, some countries or employers might require additional assessments or exams to evaluate your knowledge and skills.

  7. Professional Development : Stay updated with advancements in pharmacy practice globally and consider certifications or additional courses that enhance your skills and make you more competitive internationally.

  8. Visa and Immigration : Understand the visa and immigration requirements of the country where you intend to work, as well as any restrictions or additional qualifications needed for foreign workers.


Hope it helps!


The  hostel change around 7000 per year

Range: The B Pharma course fees in India can typically range from a minimum of 30,000 per yearto a maximum exceeding 2,00,000 per year. Government Colleges:Fees in government colleges typically fall on the lower end of the spectrum, often within the range of 30.000 to 75,000 per year

IIT BHU has four different for M. Pharmacy which are Pharmaceutics, Pharmaceutical chemistry, Pharmacology and Pharmacognosy so they declared cutoff ranks according to your marks for each category  every year cutoff changes due to various factors.They called 7 times more number students for counseling than the total seat available there.some application also get rejected because of not having gpat score and lack of eligibility so they create chance for other candidates.


So,If You want to be on Safe side you should achieve atleast below 500 rank in GPAT.

Hello aspirant

your have got moderate score of 241. You must apply for B pharm in IMS BHU .

But whether you get a seat or not depends upon this year's cut off for the Course. Cut off keeps changing every year and depends upon certain factors including previous year's cut off .

IMS BHU is one of the top colleges in varanasi.

You must apply in other colleges too , names of few colleges in varanasi offering pharmacy Course are mentioned below

Kashi Institute of technology

Ashoka Institute of technology

Shri Harishchandra pg Institute  of pharmacy

Hello,


For a national-level entrance exam for BPharma, you can consider the Graduate Pharmacy Aptitude Test. GPAT is a national level entrance exam conducted by the National Testing Agency in India. It is a computer based test that tests the aptitude and knowledge of candidates in the field of pharmacy.


Hope this helps,

Thank you


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