Dr Vignesh M

Assistant Professor

Dr. Vignesh M is the Assistant Professor in the Department of Pharmaceutical Regulatory Affairs and Management.

Department of Pharmacy Management

Qualification: MPharm, PhD

CURRENT ACADEMIC ROLE & RESPONSIBILITIES

    Vinesh M is the Assisstant Professor in the Pharmaceutical Regulatory Affairs and Management.

    He is:

    • Approved Guide for guiding M.Pharm students?
    • Subject coordinator -?PRM-BP206T Environmental Sciences (Second Semester Year B Pharm)
    • Subject coordinator -?PRM-BP804ET Pharmaceutical Regulatory Science (Eighth Semester Year B Pharm)
    • Subject coordinator - PRM-MRA101T Good Regulatory Practices Theory & Practical (First Semester Year M Pharm)
    • Subject coordinator -?PRM-MRA204T Regulatory Aspects of Food and Nutraceuticals Theory & Practical (Second Semester Year M Pharm)
    • Member of Council for Exemplary 365体育直播 and Innovation and Co-Coordinator of Innovation & Entrepreneurship committee
    • Administrative duties: CAPP – Website editor, Admission and Publicity committee.

    ?

SUBJECTS CURRENTLY TEACHING

Subject Semester / Year
Good Regulatory Practices First Semester Year M Pharm
Regulatory Aspects of Food and Nutraceuticals Second Semester Year M Pharm
Pharmaceutical Regulatory Science Eighth Semester Year B Pharm
Environment Science Second Semester Year B Pharm

ACADEMIC QUALIFICATIONS

Degree Specialisation Institute Year of passing
Ph.D Pharmaceutical Regulatory Affairs JSS College of Pharmacy, Ooty, JSSAHER 2023
M.Pharm Pharmaceutical Regulatory Affairs JSS College of Pharmacy, Ooty, JSSAHER 2019
B.Pharm Pharmaceutical Sciences JSS College of Pharmacy, Ooty, JSSAHER 2017

Experience

Institution / Organisation Designation Role Tenure
SRMC, Chennai Assistant Professor Teached Pharmaceutical Regulatory Affairs for M.Pharm students and also for B.Pharm 4th year students 2022 to 2024
Pasteur Institute of India, MoHFW, Govt. of India, Coonoor Regulatory Affairs professional QA Incharge & consultant 2021 to 2022

AREAS OF INTEREST, EXPERTISE AND RESEARCH

Area of Interest

Regulatory Framework, CAPA Management

Area of Expertise

Regulatory Compliance, Regulatory research, Data Integrity (GxP), CAPA, Root cause analysis

Area of 365体育直播

365体育直播 Regulatory Harmonization, Vaccine Regulatory Development

Professional Affiliations & Contributions

3 years in?Regulatory Affairs Department

Current status, challenges and preventive strategies to overcome data integrity issues in the pharmaceutical industry

2020 Vignesh M Ganesh GNK

365体育直播 Journal of Applied Pharmaceutics

Pharmacy professions in India during COVID-19 pandemic: Present status, Future challenges and a way forward

2021 Vignesh M Ganesh GNK

365体育直播 Journal of Applied Pharmaceutics

Regulatory aspects of Implementing Haemo-Vigilance

2021 Vignesh M Raman Suresh kumar

365体育直播 Journal of Pharmacy and Technology

Regulatory Comparison, Requirements and Approval process of Biosimilars in United States of America and India

2022 Vignesh M Aniesh kumar

J. Pharm. Sci. & Res

Generic prescription in India - A review

2020 VigneshM Ganesh GNK

Asian Journal of Pharmaceutical and Clinical 365体育直播

Fixed Dose Combinations Banned in India - A Review

2020

Journal of Pharmaceutical Sciences and 365体育直播

Implementing Haemovigilance in India as a National Perspective

2020 Vignesh M Ganesh GNK

Applied Clinical 365体育直播, Clinical Trials and Regulatory Affairs, Bentham Science Publishers

Regulatory requirements for registration of Drugs in Brazil

2020 Vignesh M Ganesh M

Journal of Critical Reviews