M Pharm - Drug Regulatory Affairs
Master of Pharmacy (M.Pharm) is the standard Postgraduate Program in Pharmacy, Master of Pharmacy (M.Pharm) in India is offered as a Postgraduate course after the completion of B. Pharm degree. The M.Pharm is a two-year course. After completing M. Pharmacy, one can seek employment in government, private or multinational organizations. There are many opportunities in Chemical, Pharmaceutical, Biotechnology and allied industries. Some can be clinical analysts, quality supervisors or Scientists, researchers, work for government departments and educational institutions.APPLY NOW
Duration : 2 years
Eligibility : Pass in B.Pharm degree from any university recognised as equivalent by RGUHS / PCI and AICTE with the minimum of 55% aggregate.
- PEO 1: Key regulatory and compliance elements with respect to Good Manufacturing Practices, Good Laboratory Practices, Good Automated Laboratory Practices and Good Documentation Practices.
- PEO 2: Understand the approval process and regulatory requirements for Drugs & Cosmetics, Medical Devices, Biological & Herbals, and Food & Nutraceuticals process of drug discovery and development and generic product development.
- PEO 3: Submissions and post approval document requirements new drugs, drug products, medical device development process.
- PEO 4: Comparative study of India with other global regulated markets for the pre-clinical and clinical development considerations of biologics.
- PO 1: Apply fundamental knowledge on various Good Regulatory Practices in GXP for pharmaceuticals, Cosmetics, Food & Nutraceuticals, Medical devices, In-vitro Diagnostic Medical Devices (IVDs) and biological products.
- PO 2: Identify the impact of Good Regulatory Practices in the Healthcare and related Industries for the readiness and conduct of audits and inspections.
- PO 3: Create, select, bring together and follow up the regulatory submission as per the requirements of various regulatory bodies and post approval document requirements of new drugs, drug products and cosmetics in regulated and semi-regulated countries.
To ensure, planned development of Pharmacy Education consistent with the Policies of the State and Nation. We are committed to provide need based, Quality Pharmaceutical Technical and Professional Human Resources to the Industry, Business and Community.