CLINICAL RESEARCH AND PHARMACOVIGILANCE

Dr. Shivkumar Shete · Dr. Arun Shanmugam · Dr. Bhumika Chandrakar · Dr. Sukanya Mehra

JEC PUBLICATION

E-boek

211

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Clinical research and pharmacovigilance are fundamental domains in contemporary healthcare that propel therapeutic therapies forward and guarantee patient safety globally. We go through six important areas in this book, examining their importance, nuances, and the changing environment that influences them. The foundation of medical innovation is clinical research, which conducts extensive testing and refinement of novel medications, treatments, and medical technologies. This discipline aims to provide answers to important queries about the efficacy, safety, and effectiveness of healthcare therapies via well planned research. We explore the stages involved in clinical trials, moral issues, and the legal structure guiding these important studies. Another pillar of healthcare is pharmacovigilance, which is the continuous observation and assessment of pharmaceuticals after they have been approved. It aims to identify, evaluate, and lessen negative effects in order to maintain the advantage of therapies above their drawbacks. We examine the crucial procedures for risk assessment, signal detection, and adverse event reporting that support the security of medical devices.

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Dr Shivkumar Shete ,currently working as an Associate Professor in the Faculty of Pharmaceutical Sciences, India. Tatyasaheb Kore College of Pharmacy, Kolhapur, Maharashtra, India , He has a rich experience of 11 years of experience in teaching & Research for Pharm.D , B. Pharmacy (Practice) , He has a qualified D. Pharmacy, B. Pharmacy, Pharm.D (P.B) and Ph.D in Pharmacy Practice, and completed P.G Diploma in Clinical Research from Annamalai University, Tamil Nadu. India, He has guided many students of Pharm.D at research level. He has more than 21 publications, Two Indian Patent grant, and received two Teacher award

Dr. M.S. Arun Shanmugam is an Associate Professor in the Department of Practice at JKKN College of Pharmacy, Kumarapalayam, Namakkal, Tamil Nadu, India. He earned his Doctor of Pharmacy (Pharm.D) degree from JKKN College of Pharmacy, affiliated with The Tamil Nadu Dr. MGR Medical University, Chennai. Dr. Arun profoundly understands Research and Innovation, Pharmacovigilance, and Pharmacy Practice. He has actively participated in and presented posters and oral presentations at numerous National/International conferences and workshops. He has been a Scientific Evaluator for poster and oral presentations at National Conferences. Dr. Arun has guided Eight undergraduate and Five postgraduate project works. He has One Patent and one design patent publication. He wrote an Book ”Pharmacy Practice” for the UG Pharmacy Students. He holds the government certification of an "Entrepreneurial Mentor" from the Tamil Nadu – Entrepreneurship Development and Innovation Institute (TNEDII) and is a member of the Institutional Human Ethical Committee at the ADR Monitoring Center of J.K.K.Nattraja College of Pharmacy in Kumarapalayam, Tamil Nadu, India. Additionally, he is a certified "Advanced Level Innovation Ambassador" by the Ministry of Education, Government of India. Furthermore, Dr. Arun serves as an Editorial Board Member of JKKN PHARMA ALERT E-Newsletter, an in-house Department of Pharmacy Practice publication. He is an active member of the Indian Pharmaceutical Association, Bhavani Kumarapalayam Local Branch, and secured an A+ Grade in the PDP on implementing NEP2020 by UGC-India. With his extensive academic achievements and experience, this book is expected to meet the needs of Pharmacy Students.

Dr. Bhumika Chandrakar , currently working as an Associate professor in the Rungta institute of pharmaceutical sciences ,Bhilai, Chhattisgarh, India. She has a rich experience of 7 years in teaching Pharm D , B. Pharmacy, D.Pharmacy, Physiotherapy . She has qualified PHARM.D from Bharti vidyapeeth university ,Pune and B. Pharmacy from Shri Shankracharya Technical Campus, Faculty of pharmacy, Chhattisgarh, India. She has guided many students of PHARM.D and B. Pharmacy at research level. She has more than 15 publications & Two Indian Patent. She has participated in various pharmacovigilance and clinical research projects

Dr. Mehra holds a Master's degree in Zoology (Hons.) and awarded PhD in cytogenetics from Department of Zoology, Guru Nanak Dev University. Dr. Mehra has more than 18 publications in esteemed peer reviewed National and International journals. She is currently working as an Assistant Professor at Khalsa College for Women and has rich experience teaching undergraduate and postgraduate courses. Dr. Mehra is also a reviewer of an esteemed Journal entitled "Environmental Science Archives".

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