About M.Pharm Regulatory Affairs


The regulatory framework and the scope of law has been on a continuous expansion in regards to the manufacturing and destribution of pharmaceutical products and such has created a demand for individuals with an indepth expertise in the regulations relating to the field. To meet this demand, the Faculty of Pharmacy offers a two year Postgraduate program in Regulatory Affairs which seeks to provide the students with an indepth understanding of the legal aspects to do with the industry. As of today, all pharmaceutical and biological products are governed by strict regulations set by the relevant regulatory authorities in the respective countries and regions of the world. Therefore the Regulatory Affairs program has been developed inorder to equip specific experts within the Pharmacy industry with the ability to provide protection to the public health, by controlling the safety and efficacy of products in areas of pharmaceuticals. The Faculty of Pharmacy has been equipped with the most State of the Art Facilties for research and experimentation which seeks to provide the students with an indepth understanding into the various aspects of the field. The students also go on to pursue this program under the instruction of expert faculties and lecturers who go on to shape the pathways of the students in preparation of their careers. Therefore pursuing this program will provide the students with an indepth understanding of the regulatory frameworks of Pharmacy.

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National Applicants

International Applicants

M.Pharm Regulatory AffairsProgram Outcomes


Why Study M.Pharm Regulatory Affairs

There has been an ever-growing demand for experts who are trained in this field and students who get to receive this know-how will get various career avenues in advising on the legal and scientific restraints and requirements and to collect, collate and evaluate the scientific data that their research and development colleagues are generating. The regulatory affairs program has been custom designed to meet the needs and requirements of the contemporary industry.
Pharmacist

Pharmacist

An ability to apply innovative medicinal and treatment modalities for diseases and viruses which may affect the well-being and livelihood of humanity as a whole.

Drug Inspector

The ability to develop the relevant soft skills and professional ethics which are vital for navigating the career landscape.

Drug Inspector
Regulations Affairs Officer

Regulations Affairs Officer

An ability to work in providing assistance towards ensuring and providing the necessary guidance in regulations and ensuring checks within the system.

Pharmaceutical Sales

An ability to make contributions to the economic scope of pharmacy through driving sales and effective marketing strategies

Pharmaceutical Sales

Duration: 2 years (Semester System)


affiliation

Affiliation

Constituent College of Parul University

eligibility

Eligibility Criteria

Candidate shall have passed B.Pharm with minimum 55% For General Category and 50% for SC/ST/SEBC category from a recognized university approved by Pharmacy Council of India (PCI).

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Mode of Admission

For admissions please visit our portal to register/login yourself and proceed ahead with your admission application.

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Faculties Offering

Faculty of Pharmacy

M.Pharm Regulatory Affairs feesFees

Country
State

M.Pharm Regulatory Affairs

₹ 1,27,890/- Annually*

* Tuition Fees may vary depending on the Country/ State in which the candidate has passed their qualifying examination.

M.Pharm Regulatory Affairs CurriculumCurriculum

Semester 1

Semester 2

Good Regulatory Practices

Regulatory Aspects of Drugs & Cosmetics

Documentation and Regulatory Writing

Regulatory Aspects of Herbal & Biologicals

Clinical Research Regulations

Regulatory Aspects of Medical Devices

Regulations and Legislation for Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food

Regulatory Aspects of Food & Nutraceuticals

Regulatory Affairs Practical I

Regulatory Affairs Practical II

Seminar Sem I

Seminar Sem II

 

Semester 3

Semester 4

Pre-Dissertation-I

Dissertation I

Pre-Dissertation-II

Dissertation II

Pre-Dissertation-III

Dissertation III

Research Methodology and Biostatistics*

 

 

M.Pharm Regulatory Affairs Curriculum Laboratories


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Research and Development Lab

As a way of promoting research, innovation and novel ideas in the field of pharmacy, Parul University, has a designated research and development laboratory.

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Computer Labs

Pharmacy education is becoming highly digital thus it maintains close ties with the contemporary trends in innovative technology therefore specific computer labs are designated for the pharmacy

https://paruluniversity.ac.in/Research lab

Research lab

https://paruluniversity.ac.in/Practical lab

Practical lab

https://paruluniversity.ac.in/Quality assurance lab

Quality assurance lab

https://paruluniversity.ac.in/Pharma-chemistry

Pharma-chemistry

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