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Subrat SaurabhAuthor of Kuch Woh Pal
Discover the world of pharmacovigilance, where patient safety takes center stage. In "Vigilance Unleashed: From Adverse Events to Patient Protection," we delve into the science and practices that safeguard patients from medication and medical devices' risks. Unravel the historical background, regulatory frameworks, and international collaborations that shape pharmacovigilance practices. From identifying adverse drug reactions to embracing emerging technologies and patient-centered approaches, this comprehensive guide equips readers with essential knowledge to navigate the dynamic landscape of pharmacovigilance confidently. Join us on this journey to champion patient safety and unleash the power of vigilance in healthcare.
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Dr. Akash Sharma, Vriti Gamta, Gaurav Luthra
Dr. Akash Sharma is a highly skilled professional in Regulatory Affairs and Quality Management System for the Medical Device Industry. With a background in Mechanical Engineering and a Ph.D., he has focused his research on applying Risk Management Principles in the Medical Device Industry. He has published various Research Papers, Books and participated in International Conferences. Dr. Sharma's expertise includes compliance with EU Medical Device Regulation, ISO 13485 for Quality Management and ISO 14971 for Risk Management. Currently, as the Regulatory Affairs Manager and Management Representative at KAULMED PRIVATE LIMITED, he ensures regulatory compliance and drives quality initiatives.
Vriti Gamta is a acquiescent book author with a track record of four published Books and seven Research Papers. She is an expert in Regulatory Affairs and Quality Management within the healthcare sector. With a Master's degree in Pharmacy, where she specialized in Drug Regulatory Affairs, she has accumulated over four years of experience in navigating complex regulations. Vriti's areas of expertise include ensuring compliance with EU Medical Device Regulation, implementing ISO 13485 for Quality Management and adhering to ISO 14971 for Risk Management. In her role as a Regulatory Affairs Executive at KAULMED PRIVATE LIMITED (KAUL-Medizintechnik GmbH), Vriti is responsible for maintaining compliance and upholding high-quality standards.
Gaurav Luthra is an author and expert in the Medical Device Industry with 17 years of experience as a Managing Director. He is currently leading as a Managing Director- KAULMED PRIVATE LIMITED (KAUL-Medizintechnik GmbH). His extensive knowledge spans manufacturing, regulatory affairs, quality management systems, and research and development. Through his research and publications, Gaurav Luthra has established himself as a prominent figure in the field, contributing to technological advancements and promoting safe and effective medical devices.
