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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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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.

ASCPT 2018 Annual Meeting https://t.co/i0mjYbBq5N Join @Bioclinica Research's Open House 3/22 https://t.co/citlLotbD7
bioclinica (Yesterday)
Heading to DC for DIA's #Pharmacovigilance & Risk Mgmt Strategies Conf.? Visit @Bioclinica in booth 32. Preview our… https://t.co/alU1sCg04l
bioclinica (Yesterday)
Kevin Bishop, named a 'Top Innovator' in #clinicaltrials by @CenterWatch See how we're reducing risk to the clinic… https://t.co/rXBGvIh9Wr
bioclinica (2 days ago)
RT @CenterWatch: Congratulations to all our #2018TopInovators! Read about the innovations in the #CWMonthly special edition, https://t.co/Y…
bioclinica (1 week ago)
RT @CenterWatch: .@Pfizer demonstrates leadership in #clinicaltrial innovation with two spots on the @CenterWatch #2018TopInnovators, https…
bioclinica (1 week ago)
RT @jheanne: I just contributed towards 'Joby' on https://t.co/EHt69JFLZ9 Best wishes to Joby and all our @Bioclinica team members! @Oxfam…
bioclinica (1 week ago)

Latest Blogs:

Removing Risk from Clinical Trial Management System (CTMS) Implementations
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success
The Value of Protocol Review
CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen