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Programme Level
Duration
The M.Pharm Regulatory affairs programme is designed to provide in-depth knowledge of the laws, regulations, and guidelines governing the development, approval, manufacturing, and marketing of pharmaceutical products. It prepares students to navigate the complex regulatory environments of different countries, ensuring that products meet safety, efficacy, and quality standards. The programme covers topics such as regulatory submission processes, documentation, compliance, and global regulatory requirements. Graduates are equipped to work in regulatory departments of pharmaceutical companies, helping to bring safe and effective medicines to market efficiently and legally.
B.Pharm with minimum 55% marks
01
Pharmacy Knowledge: Possess knowledge and comprehension of the core and basic knowledge associated with the profession of pharmacy, including biomedical sciences; Pharmaceutical sciences; behavioral, social, and administrative issues of Pharmacy sciences.
02
Planning Abilities: Demonstrate effective planning abilities including time management, resource management, delegation skills and organizational skills. Develop and implement plans and organize work to meet deadlines.
03
Problem Analysis: Utilize the principles of scientific enquiry, thinking analytically, clearly and critically, while solving problems and making decisions during daily practice. Find, analyze, evaluate and apply information systematically and shall make defensible decisions. Modern tool usage: Learn, select, and apply appropriate methods and procedures, resources, and modern pharmacy-related computing tools with an understanding of the limitations.
04
Modern Tool Usage : Utilize the principles of scientific enquiry, thinking analytically, clearly and critically, while solving problems and making decisions during daily practice. Find, analyze, evaluate and apply information systematically and shall make defensible decisions.
05
Leadership Skills: Understand and consider the human reaction to change, motivation issues, leadership and team-building when planning changes required for fulfillment of practice, professional and societal responsibilities. Assume participatory roles as responsible citizens or leadership roles when appropriate to facilitate improvement in health and wellbeing.
06
Professional Identity: Understand, analyze and communicate the value of their professional roles in society (e.g. health care professionals, promoters of health, educators, managers, employers, employees).
07
Pharmaceutical Ethics: Honor personal values Use ethical frameworks; apply ethical principles while making decisions and take responsibility for the outcomes associated with the decisions.
08
Communication: Communicate effectively with the community and with society, such as, being able to comprehend and write effective reports, make effective presentations and documentation, and give and receive clear instructions.
09
The Pharmacist and society: Apply reasoning informed by the contextual knowledge to assess societal, health, safety and legal issues and the consequent responsibilities relevant to the professional pharmacy practice.
10
Environment and sustainability: Understand the impact of the professional pharmacy solutions in societal and environmental contexts, demonstrate the knowledge of, and need for sustainable development.
11
Life-long learning: Recognize the need for, and have the preparation and ability to engage in independent and life-long learning in the broadest context of technological change. Self access and use feedback effectively from others to identify learning needs and to satisfy these needs on an ongoing basis.
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.
Equip the students with comprehensive knowledge and skills to deliver regulatory services in regulated, semi-regulated and poorly regulated markets.
Empower and sensitize the regulatory affairs professionals to serve the pharmaceutical industry, academia, society and the business.