Welcome to Best M.Pharm College
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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.
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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
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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
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Eligibility & Intake :-
Candidate should have passed B.Pharma from recognized university.
Duration - 2 years
Intake - 9