FDAMap Videos: HD videos covering latest topics wherein regulatory experts simplify FDA regulations, compliance, Audit, Inspections and clinical trials complexities for drugs, biologics, and medical devices.

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FDA Regulations for Importing and Exporting Medical Devices

By Dr. Mukesh Kumar, PhD, RAC
Regulatory Affairs and Quality Assurance
​Lead Consultant and Speaker, FDAMap
German Town, MD 20784, USA
[email protected]

Managing a Clinical Trial Project
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Clinical Trials, being large projects, involve people from doctors to nurses to technicians and the patients, of course. This conversation with Dr Mukesh Kumar will help understand how to manage clinical trial projects.

To learn more about different aspects of clinical trials and latest clinical trial news, please register for FDA Puran newsletter at www.fdamap.com/news-releases

Clinical Trials' Quality Standards

Are all clinical trials identical? What are basic differences between different trials? What are quality standards for clinical trials? In this video, Dr. Mukesh Kumar, a Washington DC based Regulatory Affairs and Quality Assurance expert, throws some light on quality standards basics of clinical trials.

To learn more about different aspects of clinical trials and latest clinical trial news, please register for FDA Puran newsletter at www.fdamap.com/news-releases

Drug Product Life Cycle Management by DLTA (Drug Life Tracking Application). 

In this video, Dr. Mukesh Kumar, a Washington DC based Regulatory Affairs  and Quality Assurance expert, throws light on how DLTA can automate clinical trial projects and ease the entire drug life cycle process resulting in expedited drug approval.

Learn more about DLTA at http://druglifecycle.com

Why Do Clinical Trials Fail? (Part 1)

​A recent study found that most clinical drug trials fail. There is one main reason why those clinical trials fail, too.

Dr. Mukesh Kumar, a Washington DC based Regulatory Affairs  and Quality Assurance expert, throws light on why do most clinical drug trials fail.
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Why Do Clinical Trials Fail? (Part 2)

Dr. Mukesh Kumar, a Washington DC based Regulatory Affairs  and Quality Assurance expert, throws light on why do most clinical drug trials fail.

The FDA Regulation of Software in Clinical Trials 

Not all software is regulated by FDA. Some software may be regulated depending on what it does. You can take a lot of what we know about clinical trials and design software for the task. Dr. Mukesh Kumar explains about the same.

What is a Clinical Trial Feasibility Study?

Clinical Trial Feasibility Studies basic means finding the right investigators, patients and determining costs. It is done to evaluate how the test could fail then decide to proceed or not to proceed. Dr. Mukesh Kumar discusses about this feasibility study.
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