M. PHARM (REGULATORY AFFAIRS)

The regulatory affairs course is designed to provide knowledge in the area of global regulatory needs at the various stages of Pharmaceutical product development with respect to manufacturing, marketing authorization, clinical trials, import, export, registration and compliance. It covers the vast area of regulatory needs in Pharmaceuticals, Cosmetics, Food, Nutraceuticals, Medical devices and Biological products. Regulatory Affairs knowledge is a key component in pharma ìndustry drives the Research and Development tasks for getting timely marketing approval from different regulatory agencies all over the world. It is designed to familiarize the students with regulatory agencies globally like USFDA, TGA-Australia, UK-MHRA and other regulated and semi-regulated markets. The course will make the students industry-ready with expertise and skills in the area of regulatory affairs.

USPs of Program

• Tailor-made course suitable for pharmaceutical industries and research organizations
• Facilitating global knowledge of Regulatory Affairs
• Identification and resolution of regulatory issues with regulatory agencies
• Case studies from top industry executives
• Experienced and vibrant faculty with expertise in regulatory affairs and research areas
• Frequent interaction with industry and research team
• Opportunity to grow with industrial training and working on current projects
• Updated information on federal and international regulations

Duration

The course is of two years duration, consisting of two semesters in the first year, followed by research & project work based on regulatory affairs and submission of dissertation in the second year.

Eligibility

• B.Pharm. examination with 55% of marks from (PCI) Pharmacy Council of India Approved Institute.
• Candidates appearing for final year B.Pharm can also apply.

Selection Process

Personal Interview

Intake

15 Seats

Attendance

For an academic year, a student is expected to have 80% of total attendance in each subject.

Value Proposition

• Knowledge of registration procedures for marketing drug products and cosmetics in regulated and semi-regulated countries.
• Current regulatory needs of USA, Canada, European Union, Australia, Japan, Emerging Markets, Brazil, ASEAN, CIS and GCC Countries
• Knowledge of documentation related to submissions to regulatory agencies globally.
• Exposure to recent Regulatory based projects and case studies
• Participating in the development of new products, services and quality audits

Program Objectives

• Specially designed course suitable for job placement in pharmaceutical industries & research organizations
• Top level senior faculty with expertise in regulatory affairs and Pharmacy research areas
• Interfacing with regulatory agencies
• Interaction with industry and other research related organizations
• Opportunity to develop documentation for drugs & cosmetics, Medical devices, Biologicals & herbals, and Food & Nutraceuticals.
• Regulatory Requirements for Biologics, Vaccines and Blood Products
• Need-based updation in industry related areas for best regulatory practices, documentation, regulatory writing and clinical research regulations
• Case studies related to regulatory needs of regulated markets of USA, Canada, European Union, Australia and Japan
• Case studies related to regulatory needs of Emerging Markets, Brazil, ASEAN, CIS and GCC Countries.
• Industry-oriented regulatory study model with opportunity to have electives of special interest

Pedagogy

The institute believes that self-learning is the best means of learning, especially at the post graduate level, and accordingly, faculty should act as facilitators more than teachers. A great deal of emphasis is therefore placed on experiential learning. Students are required to work on a number of industrial and academic research projects during two years that they are on campus. In addition, teaching is heavily oriented towards case studies, presentations, quizzes, assignments, workshops and labs. A variety of seminars are organized by students and faculty members during the academic session. There is a strong belief that at the Institute in ‘learning by doing’ and in the dictum that true pharmaceutical education goes beyond the classroom. The students are therefore exposed to technical depth of the subject and are also encouraged to participate in all professional activities.The students will develop strong skills through exposure to regulatory projects and case studies during the course period that will enable them to translate their knowledge into practice.

Curriculum

Career Opportunities

M.Pharm Drug Regulatory Affair offers the candidates a niche career option. The course enables the candidates to work in the Healthcare and Pharmaceutical industry.The pharmaceutical industry is regulated by the government or other agencies. This makes it mandatory for a company to have a registration and regulatory affairs department to comply with the requirements of regulatory bodies. Thus, the knowledge of Regulatory Affairs is very crucial for an organization & creates employment opportunities for specialized course on Regulatory Affairs.