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 Audit Definition of Unacceptable Behaviour During FDA Audits

FDA inspections are intimidating events. The audited parties could intentionally or unintentionally behave in ways that are deemed as delaying, denying, limiting or refusing inspection by the FDA inspectors which are all illegal activities with serious consequences. FDA released a new guidance document and provided examples based on what the FDA inspectors have faced during audits.

Real-World Evidence and the FDA | Transforming Clinical Research & Patient Care

Real World Evidence provides the clinical evidence we need to make informed decisions about the safety, efficacy, and real-world performance of medical products. FDA has issued new guidance on Real World Evidence. Learn hhat is FDA Acceptable Real World Evidence. Webinar on Real World Evidence: https://shorturl.at/wuvyn

Managing a Clinical Trial Project

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.

Animal Clinical Studies for Drug Development | Ethical Considerations

In this video, Dr. Mukesh Kumar (Washington DC based FDA regulatory expert) discusses animal clinical studies, ethical considerations and approval from animal ethical committees.

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