M. Pharm in Regulatory affairs
July 1, 2024 2024-07-09 16:49M. Pharm in Regulatory affairs
M. Pharm in Regulatory affairs
The course in Pharmaceutical Regulatory Affairs provides a comprehensive understanding of the regulatory frameworks and processes involved in the development, approval, and post-market surveillance of pharmaceutical products. It covers key areas such as regulatory strategy development, submission processes for regulatory approval, compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP), and the role of major regulatory authorities like the FDA, EMA, and others. The course also emphasizes the importance of regulatory intelligence, labeling and advertising compliance, and post-market monitoring, equipping students with the necessary skills to navigate the complex regulatory landscape and ensure the safety and efficacy of pharmaceutical products.
A Pass in the following examinations
a) Pharm Degree examination of an Indian university established by law in India from an institution approved by Pharmacy Council of India and has scored not less than 55 % of the maximum marks (aggregate of 4years of B. Pharm.)
b) Every student, selected for admission to post graduate pharmacy program in any PCI approved institution should have obtained registration with the State Pharmacy Council or should obtain the same within one month from the date of his/her admission, failing which the admission of the candidate shall be cancelled.
Note: It is mandatory to submit a migration certificate obtained from the respective university where the candidate had passed his/her qualifying degree (B. Pharm.) Proficiency in the English language may be required for international applicants.
A career in Pharmaceutical Regulatory Affairs offers diverse and rewarding opportunities in the pharmaceutical, biotechnology, and medical device industries. Professionals in this field play a crucial role in ensuring that products comply with regulatory standards and reach the market efficiently. Here are some key career prospects:
- Regulatory Affairs Specialist/Associate:
- Entry-level roles focusing on preparing and submitting regulatory documents, maintaining regulatory databases, and supporting product registrations and approvals.
- Regulatory Affairs Manager:
- Mid-level roles involving the management of regulatory submissions, strategic planning for regulatory approvals, and coordination with cross-functional teams to ensure compliance with regulations.
- Regulatory Affairs Director/Head:
- Senior-level positions responsible for overseeing the entire regulatory affairs department, developing regulatory strategies, liaising with regulatory agencies, and ensuring that all products comply with international regulations.
- Compliance Officer:
- Ensuring that the company’s operations, from manufacturing to marketing, adhere to regulatory standards and implementing corrective actions when necessary.
- Regulatory Consultant:
- Providing expert advice to pharmaceutical companies on regulatory strategies, submissions, and compliance, often working for consulting firms or as independent contractors.
- Quality Assurance Manager:
- Overseeing the implementation of quality systems, conducting audits, and ensuring compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
- Clinical Regulatory Affairs Specialist:
- Focusing on the regulatory aspects of clinical trials, including the preparation of clinical trial applications, ensuring compliance with Good Clinical Practices (GCP), and managing interactions with regulatory bodies.
- Regulatory Intelligence Analyst:
- Monitoring and analyzing global regulatory trends and changes, providing insights to help companies anticipate and adapt to new regulatory requirements.
- Labeling and Advertising Compliance Specialist:
- Ensuring that product labels, packaging, and promotional materials comply with regulatory guidelines and accurately represent the product.
- Post-Market Surveillance Specialist:
- Monitoring the safety and efficacy of products after they have been marketed, managing adverse event reporting, and coordinating product recalls if necessary.
Course of study
Semester I
| Course Code | Course | Credit Hours | Credit Points | Hrs./w k | Marks |
| MRA101T | Good Regulatory Practices | 4 | 4 | 4 | 100 |
| MRA102T | Documentation And Regulatory Writing | 4 | 4 | 4 | 100 |
| MRA103T | Clinical Research Regulations | 4 | 4 | 4 | 100 |
| MRA104T | Regulations and Legislation for Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and food & Nutraceuticals in India and Intellectual Property Rights | 4 | 4 | 4 | 100 |
| MRA105P | Regulatory Affairs Practical I | 12 | 6 | 12 | 150 |
| Seminar/Assignment | 7 | 4 | 7 | 100 | |
| Total | 35 | 26 | 35 | 650 |
Semester II
| Course Code | Course | Credit Hours | Credit Points | Hrs./w k | Marks |
| MRA201T | Regulatory Aspects of Drugs & Cosmetics | 4 | 4 | 4 | 100 |
| MRA202T | Regulatory Aspects of Herbals & Biologicals | 4 | 4 | 4 | 100 |
| MRA203T | Regulatory Aspects of Medical Devices | 4 | 4 | 4 | 100 |
| MRA204T | Regulatory Aspects of Food & Neutraceuticals | 4 | 4 | 4 | 100 |
| MRA205P | Regulatory Affairs Practical II | 12 | 6 | 12 | 150 |
| Seminar/Assignment | 7 | 4 | 7 | 100 | |
| Total | 35 | 26 | 35 | 650 |
| PO1 | Pharmacy Knowledge Possess knowledge and comprehension of the core information associated with the profession of pharmacy, including biomedical sciences; pharmaceutical sciences; behavioural, social, and administrative pharmacy sciences; and manufacturing practices. |
| PO2 | Thinking Abilities Utilise the principles of scientific inquiry, thinking analytically, clearly and critically, while solving problems and making decisions during daily practice. Find, analyse, evaluate and apply information systematically and shall make defensible decisions. |
| PO3 | Planning Abilities Demonstrate effective planning abilities including time management, resource management, delegation skills and organisational skills. Develop and implement plans and organise work to meet deadlines |
| PO4 | Leadership skills Understand and consider the human reaction to change, motivation issues, leadership and team building when planning changes required for fulfilment of practice, professional and societal responsibilities. Assume participatory roles as responsible citizens or leadership roles, whenever appropriate, to facilitate improvement in health and well-being. |
| PO5 | Professional Identity Understand, analyse and communicate the value of their professional roles in society (e.g. health care professionals, suppliers of pharmaceuticals, promoters of health, educators, business managers, employers, employees) through consideration of historical, social, economic and political issues. |
| PO6 | The Pharmacist and society Apply reasoning informed by the contextual knowledge to assess societal, health, safety, legal, and cultural issues and the consequent responsibilities relevant to the professional pharmacy practice. |
| PO7 | Environment and sustainability Understand the impact of the professional pharmacy solutions in societal and environmental contexts, and demonstrate the knowledge of, and need for sustainable development. |
| PO8 | Ethics Honour personal values and apply ethical principles in professional and social contexts. Demonstrate behaviour that recognises cultural and personal variability in values, communication and lifestyles. Use ethical frameworks, apply ethical principles while making decisions, and take responsibility for the outcomes associated with the decisions. |
| PO9 | Communication Communicate effectively with the pharmacy community and with society at large, such as, being able to comprehend and write effective reports, make effective presentations and documentation, and give and receive clear instructions. |
| PO10 | Modern tool usage Learn, select, and apply appropriate methods and procedures, resources, and modern pharmacy-related computing tools with an understanding of the limitations. |
| PO11 | Life-long learning Recognise 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-assess and use feedback effectively from others to identify learning needs and to satisfy these needs on an ongoing basis |
Facilities
Faculty
Department of Regulatory affairs
Name of the faculty | Designation | Years of Experience |
Dr. Prakash S Goudanavar | Professor & Head | 24 Years |
Dr. Vedamurthy Joshi | Professor | 14 Years |
Dr. Kirankumar G.B | Professor | 21 Years |
Dr. N Raghavendra Naveen | Asso. Professor | 10 years |
Dr. Jayatheertha S Lokapur | Asst. Professor | 08 Years |
Dr. Abhishek B V | Asst. Professor | 03 Years |
Mrs. Mallamma. T | Asst. Professor | 09 Years |
Mr. Madhu B K M. Pharm | Asst. Professor | 09 years |
Mr. Suhas N S M. Pharm | Asst. Professor | 02 Years |
Mr. Amar S M. Pharm | Asst. Professor | 02 Years |
