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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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Leader in Clinical Trial
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.

ICYMI: Take a look at Bioclinica Clinical Adjudication that caught the judges' eye in the recent Scrip Awards. It's… https://t.co/gPk4aLmTuA
Bioclinica (2 weeks ago)
Still time to catch up with Aina Lihn, Kathleen Kane, Anette Vierning and other Bioclinica folks at #PCTRIALS https://t.co/E3qxdjqTV5
Bioclinica (2 weeks ago)
Awesome day 2 at #PCTRIALS in Barcelona! Great to connect w new & long-time partners & #lifescience clients! https://t.co/ElM3VPCoSk
Bioclinica (2 weeks ago)
Great talk by @bioclinica's CIO & EVP Technology Gavin Nichol at #PCTRIALS 2018 on #FDA recent guidance on EHR EDC… https://t.co/geIjGIFL06
Bioclinica (2 weeks ago)
Great talk by @bioclinica's CIO & EVP Technology Gavin Nichols at #PCTRIALS 2018 on #FDA recent guidance on EHR EDC… https://t.co/agqP32q09W
Bioclinica (2 weeks ago)
Ask us about technology-enabled clinical development powered by science! Hear our CIO in a day 2 talk. See… https://t.co/iZyF8ixV79
Bioclinica (3 weeks ago)

Latest Blogs:

Nonalcoholic steatohepatitis (NASH) development programs
Dr. Joby John
Transformational Trends in Investigator Site Payments
Clinical Supply Chain Success: Leveraging Technology
Blood pressure monitor
Prescription box
Latin America: Benefit from the Right Partner