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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