M.Pharm. Pharmaceutical Regulatory Affairs

Campus

Kattankulathur (KTR)

Sanctioned Intake

15

Annual Fees

INR 2,00,000

Duration

2 years

About the Department

Master of Pharmacy (M Pharm) in Pharmaceutical Regulatory Affairs is a 2 year postgraduate Pharmacy programme. The profession of Regulatory Affairs acts as the interface between the pharmaceutical industry and drug regulatory authorities across the world. It plays a very important role in the journey of a product from the laboratory to the pharmacy. This programme is a unique mixture of science and management with an objective to achieve a commercially important goal within a drug-development organization. Regulatory Affairs involves the process of development plan, supervising-writing / reviewing and assembling & submission management. This course is designed to impart fundamental knowledge on Good Regulatory Practices, Documentation and Regulatory Writing, Clinical Research Regulations, Intellectual Properties Rights, Marketing Registration of Drugs and Cosmetics, Medical Devices and Nutraceuticals, Research Methodology and Biostatics among others. After this course, students will demonstrate competency in regulatory guidance on a drug approval process and good regulatory practices. They shall also undergo internship in a pharmaceutical company for practical knowledge. The curriculum and syllabi are guided as per Pharmacy Council of India (PCI), the statutory body governing pharmacy profession in the country. SRM with its well equipped laboratory setup matching industry standards, inter-disciplinary learning and research outcomes with the SRM Medicine & Health Science institutions, qualified and experienced faculty, industry oriented curriculum, placement opportunities and faculty-student mentorship program for every student offers you a distinct advantage over its peers in the field of pharmaceutical education.

Eligibility for M.Pharm

1. Candidate shall have passed a Bachelor’s degree in Pharmacy from a PCI approved institution.
2. Minimum of 50% aggregate of marks in Bachelor’s Degree.
3. Students should submit Pharmacist Registration Certificate obtained from the respective state pharmacy council at the time admission.
4. Age: Minimum age limit is 21 years on or before 31st December of year of Admission.

Program Outcomes

PO1

Pharmacy Knowledge: Demonstrate competency in regulatory guidance on drug approval research, registration and good regulatory practices (GxP).

PO2

Planning abilities: Develop competency in problem identification, analysis and solving.

PO3

Problem Analysis: Demonstrate competency in designing regulatory case studies and suggest remedies in situations of issuance of warning letters

PO4

Modern tool usage: Implement the knowledge for conducting regulatory audits and investigations on quality issues in drug manufacturing and clinical research

PO5

Leadership skills: Demonstrate competency in implementing modern tools like electronic Common Technical Document (e-CTD).

PO6

Professional Identity: Demonstrate competency to be entrepreneurs in the Pharmaceutical field to serve the society.

PO7

Pharmaceutical Ethics: Comprehend the impact of pharmaceutical industry operations on the environment and strive to make the pharmaceutical manufacturing sustainable.

PO8

Communication: Inculcate ethical values in the conduct of clinical research and in profession.

PO9

The Pharmacist and society: Cultivate a sense of compliant partnering collaborative spirit in professional duties; develop transdisciplinary approaches in the area of pharmaceutical sciences through choice / problem-based learning.

PO10

Environment and sustainability: Conceptualize research ideas, develop oral and written communication skills including soft skills, frame and evaluate hypothesis by collating and interpreting data to draw meaningful conclusions.

PO11

Life-long Learning: Students will be skilled in managing human, financial and other resources efficiently to achieve the project objectives and stake holder’s satisfaction.

Program Education Objective

PEO No Education Objective
PEO1 Build an education leading to a Masters’ degree in Pharmaceutical Regulatory Affairs with integrated professional knowledge and skills in interpreting regulatory guidelines and practices in a changing regulatory environment.
PEO2 Equip the Masters’ students with comprehensive knowledge and skills to deliver regulatory services in regulated, semi-regulated and poorly regulated markets.
PEO3 Empower and sensitize the regulatory affairs professionals to serve the pharmaceutical industry, academia, society and the business.
PEO4 Cultivate an inclination for higher education, consultancy and entrepreneurship.
PEO5 Foster in class hands on training through case study, group discussion and decision making

Program Specific Outcomes

PSO No Specific Outcomes
PSO1 Understand and apply the Regulatory knowledge of drugs, medical devices, nutraceutical in the aspects of marketing authorization approval.
PSO2 Foster the best in-class hands-on training in dossier submissions as per global standards and empower the other regulatory submission skills
PSO3 Understand and appraise the concepts of various regulations and ethical regulations governing pharmacovigilance, clinical research guidelines with the international regulatory approval process.

how to apply

Step 1 - register

Sign up or Register for CET with basic details (Name, Email ID, Mobile No., State, Gender and Password). Your Email ID will act as your Username for the portal while the password will be set by you upon registration.

On successful registration, you will receive the confirmation message on your registered contact number and Email. Use the Username and Password to Login to your CET Account.

Apply now

syllabus

Semester - I

code

course title & Curriculum (PDF)

Hours / Week

Credits

L

T

P

C

MRA101T

Good Regulatory Practices

-

-

-

4

MRA102T

Documentation and Regulatory Writing

-

-

-

4

MRA103T

Clinical Research Regulations

-

-

-

4

MRA104T

Regulations and Legislation for Drugs and Cosmetics, Medical Devices, Biologicals and Herbals, and Food and Nutraceuticals In India and Intellectual Property Rights

-

-

-

4

MRA 105P

Pharmaceutical Regulatory Affairs Practical - I

-

-

-

6

MPH100S

Seminar and Assignment

-

-

-

4

M.Pharm Regulations

Year 2017