Post Graduate Diploma in Pharmaceutical Regulatory Affairs,Highlights, Entrance Exam, admission, Eligibility, Duration, Selection Criteria, How to Apply, Application Form, Application Process, fee, Syllabus,Salary and Jobs,career opportunities
A Post Graduate Diploma in Pharmaceutical Regulatory Affairs is a specialized program that equips students with knowledge and skills related to the regulatory environment of the pharmaceutical industry. Here are some of the highlights of the program:
Post Graduate Diploma in Pharmaceutical Regulatory Affairs Entrance Exam:
Some institutes may conduct an entrance exam to select candidates for the program.
Post Graduate Diploma in Pharmaceutical Regulatory Affairs Admission:
Admissions are usually merit-based, and candidates are selected based on their academic qualifications and performance in the entrance exam (if applicable).
Post Graduate Diploma in Pharmaceutical Regulatory AffairsEligibility:
The eligibility criteria may vary from institute to institute, but generally, candidates should have a Bachelor's degree in Pharmacy or any other related field from a recognized university with a minimum aggregate of 50% marks.
Post Graduate Diploma in Pharmaceutical Regulatory Affairs Duration:
The duration of the program is usually one year, but it may vary depending on the institute.
Post Graduate Diploma in Pharmaceutical Regulatory Affairs Selection Criteria:
The selection criteria may vary from institute to institute, but generally, candidates are selected based on their academic qualifications and performance in the entrance exam (if applicable).
Post Graduate Diploma in Pharmaceutical Regulatory Affairs How to Apply:
Candidates can apply for the program by filling out the application form available on the institute's website and submitting it along with the required documents and application fee.
Post Graduate Diploma in Pharmaceutical Regulatory Affairs Application Form:
The application form can be obtained from the institute's website or by visiting the institute's admission office.
Post Graduate Diploma in Pharmaceutical Regulatory Affairs Application Process:
The application process usually involves filling out the application form, attaching the required documents and application fee, and submitting the form online or in-person.
Post Graduate Diploma in Pharmaceutical Regulatory AffairsFee:
The fee for the program may vary from institute to institute, but generally, it ranges from INR 50,000 to INR 2,00,000.
Post Graduate Diploma in Pharmaceutical Regulatory AffairsSyllabus:
The syllabus of the program may vary from institute to institute, but generally, it covers topics such as pharmaceutical regulations, drug development process, clinical trials, regulatory affairs in different countries, pharmacovigilance, and intellectual property rights.
Post Graduate Diploma in Pharmaceutical Regulatory Affairs Salary and Jobs:
After completing the program, candidates can work in various roles such as Regulatory Affairs Manager, Regulatory Affairs Specialist, Quality Assurance Manager, Quality Control Manager, Clinical Research Associate, and Medical Writer. The salary of candidates varies depending on their experience and job profile, but generally, candidates can expect to earn between INR 3,00,000 to INR 10,00,000 per annum.
Post Graduate Diploma in Pharmaceutical Regulatory Affairs Career Opportunities:
The pharmaceutical industry is growing rapidly, and there is a high demand for professionals who have knowledge and skills related to regulatory affairs. After completing the program, candidates can work in various sectors such as pharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies. They can also pursue higher education such as a PhD in Pharmaceutical Regulatory Affairs or related fields.
Before a medication or a restorative gadget can enter any market, it needs to satisfy all the material administrative prerequisites and addition endorsement from the concerned administrative bodies. Administrative and statistic condition is a piece of test to the pharmaceutical and the restorative gadget industry. The genuine battle is to characterize the system, improvement of proper marketable strategy and productive execution of the equivalent. For that specialized mastery is required. All representatives ought to know about the desires and techniques inside the organization. Appraisal of representatives is done based on their insight and ability.
IGMPI offers Post Graduate confirmation in Regulatory Affairs with the significant territory of push being the administrative situation for Medical Devices. The educational program is structured and created by specialists from the therapeutic gadget administrative industry and is centered around both hypothetical and viable angles. The course is intended for Graduates and Post Graduates, utilized in addition to yet to be utilized applicants willing to enter this energizing field of contact between the specialized parts of a restorative gadget just as the legitimate job of entries and endorsements.
Future and profession prospects
NOTE:- Students who are admitted must bring all the original documents to with them to the Institute Campus. Students failing to present all relevant original documents upon request may be denied admission or later told to leave the university.
Given below are few of the important highlights of the program.
Program Full Name | Post Graduate Diploma in Pharmaceutical Regulatory Affairs |
Program Level | PG Diploma Courses |
Duration of the Program | 1 Year |
Examination Type | Semester |
Eligibility | Graduate in Any Streams From a Recognized University With a Minimum Aggregate of 50% Marks |
Admission Process | Entrance Exam and Merit Based |
Average Program Fee | Upto Rs. 1 Lakh |
Syllabus of Medical as prescribed by various Universities and Colleges.
Paper Code | Subjects of Study |
1 | Introduction to Global Regulatory Authorities for pharma and healthcare industries |
2 | Drug Development Process, Clinical Trials and related norms and regulations |
3 | GMP and other good practices (International perspective of USA, WHO, ICH & Europe / Australia & New Zealand / Gulf Countries (GCC) / Canada / Africa / India etc) |
4 | Documentation of drug trials and regulatory filings in US, Europe, UK, India, Japan, Canada, Australia, South Africa, etc. |
5 | Quality Assurance and Drug Regulations, ICH and WHO guidelines |
6 | Dossier preparation in CTD format, eCTD submissions |
7 | Healthcare Industry IPR, Patents, copyrights and Trademarks |
8 | Pharma and Healthcare products- Marketing, Import and Export regulations |
9 | Compliance guidelines, Govt. Audits (FDA, MHRA, PMDA, TGA, DCG, etc) and Breach reports |
10 | Indian GMP Regulations |
11 | Drug Registration in African Countries |
12 | Drug Registration in Gulf (GCC) Countries. |
13 | AYUSH Regulatory Affairs (Ayurveda, Unani, Siddha, Homeopathy, Yoga and Naturopathy) |
14 | Industry specific case studies |
Mentioned below are some states in India that offer the program.