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Mahesh Kumar

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Dr. Mahesh Kumar KN MD
Director of Client Engagements

Dr. Mahesh Kumar KN, Director of Client Engagements at Bioclinica has over 14 years of experience in Pharmacovigilance (PV), clinical research and clinical practice plus, strong PV operations knowledge where he started as a drug safety physician, and was a PV project manager to various EU and US pharmaceutical sponsors. Dr. Kumar has extensive expertise in multiple therapeutic areas for drugs and devices. Additionally, he has strong knowledge of USFDA, EU, Japan, and other emerging markets regulatory requirements for Safety of Medicines with proficiency in safety databases, and was a former deputy QPPV for one EU Sponsor company.

Blogs

The Indian Pharmacopeia Commission recently published a Pharmacovigilance Guidance Document for all Market Authorization Holders (MAHs) of Pharmaceutical Products in India, which will be effective January 2018. This is a welcome change to the Indian pharmacovigilance (PV) system both for patients and pharmaceutical industries.

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Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

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