Welcome to Best M.Pharm College
M.Pharm in Regulatory Affairs
- Guru Nanak Institute of Pharmaceutical Science & Technology (under the aegis of JIS GROUP) is the Topmost & Best Private NIRF Ranked & Accredited Pharmacy College in India, and the first in the state of West Bengal - Kolkata & in Eastern India to introduce post-graduation (M.Pharm) in Regulatory Affairs Course under Maulana Abul Kalam Azad University of Technology (MAKAUT) formerly known as West Bengal University of Technology (WBUT).
- Regulation approvals are the major step that drives the R &D efforts of the industry to the market where the timely marketing approvals from a particular country to dominate the current global competitiveness. Some of such major international agencies include USFDA-US, EDQM-Europe, TGA-Australia, MHRA-UK and TPD-Canada, etc. During the course of studies, students have to present specific regulatory issues for a drug or device along with justification and strategy. This will help the students to acquire up-to-date knowledge, scientific and legal writing, analytic and reasoning skills as well as effective communication.
After completing the M. Pharm. in Drug Regulatory Affairs, (DRA) the students will be able:
• To optimize regulatory procedures,
• To develop documentation
• To know the Regulatory processes in drug develop formulations, novel drug delivery systems and devices.
• To update knowledge with new legislation in a constantly changing environment,
• To know the regulatory process in drug development, formulations, novel drug delivery systems and devices.
• To understand the system for the submission of DMF, e-CTD, Dossier, etc.
• To understand the marketing authorization, regulatory
The DRA department is more focused towards current regulatory needs for development and growth of pharmaceutical sector with continuous input on advanced research in the following areas:
• Regulatory affairs for clinical trials
• Regulatory requirements of pharmaceuticals
• Emerging Concept in Regulatory Affairs
• Good Manufacturing Practice
• International Regulatory Systems
• National and International Drug Approvals
• Pharmaceutical Biostatistics & Computer Applications
• National and International Drug Approvals & Bioethics
• Quality assurance in regulatory affairs
• National Regulatory Affairs
• Research Methodology & Pharmacological Screening
Eligibility & Intake :-
Candidate should have passed B.Pharma from recognized university.
Duration - 2 years
Intake - 9