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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.

Still time to catch up on summer reading on recent developments in #Alzheimer's Disease Fluid Biomarkers here int t… https://t.co/kyQmz7FxlN
bioclinica (2 days ago)
Our clients have substantial success w #eSource, some spanning well over a decade. Still other organizations remain… https://t.co/UwVs6ajPp4
bioclinica (3 days ago)
Our clients have substantial success w #eSource, some spanning well over a decade. Still some in the industry remai… https://t.co/ASuUvN6xb9
bioclinica (5 days ago)
RT @RfwrightLSL: When Do You Think #BYOD (Bring Your Own Device) Will Become Widely Used To Capture PRO Data In #Clinical #Research? https:…
bioclinica (2 weeks ago)
ICYMI: Our V.P./Head of Neuroscience & Cardiovascular Svcs., Dr. Joyce Suhy, talks about challenges in determining… https://t.co/Lns6B3VPPN
bioclinica (2 weeks ago)
RT @FCR_News_Today: FDA Issues New Guides on Use of Electronic Health Information in #ClinicalTrials. #ClinicalResearch https://t.co/j8LHV2…
bioclinica (2 weeks ago)

Latest Blogs:

Latin America: Benefit from the Right Partner
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