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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The use of wearable devices is increasing in clinical trials with more than half of the clinical trials estimated to have employed these devices in 2020. There is scant guidance from FDA regarding regulatory requirements for use of such devices in clinical trials. Wearable and personal communication devices such as Smartphones, tablets, Smartwatches, health-tracking devices make it easy to capture patient reported outcomes (PROs) in real-time using apps. The use of “Bring-Your-Own-Device (BYOD) format has made it more convenient and less expensive for both Sponsors and patients. Even post-approval collection of safety and real-world evidence (RWE) for clinical outcomes can be highly facilitated by electronic devices. It is important that developers and Sponsors carefully review current FDA requirements to increase acceptability of data collected using such devices by FDA. This seminar will discuss FDA-compliant best practices and tips for successfully using Smartphone, Smartwatch, and other devices in clinical trials.
All clinical trials can benefit from using common electronic devices. Consideration should be given to the use of wearable or non-wearable devices to capture critical information for clinical trials. This seminar will discuss all relevant aspects of using electronic devices in clinical trials, FDA rules for such devices, practical concerns, and suggested solutions. Dr. Kumar will share tips and checklist based on industry best practices for using smart devices in clinical trials.
13 January 2023 - 22 February 2023: Regular $0 Member | $25 Non-Member
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.
Regulatory affairs professionals involved in clinical trials, biologics and devices.
His latest company, Akan Biosciences, is developing state-of-the-art regenerative and reparative cell therapies, where he serves as the Chairman of the Board. Akan Biosciences is one of the only companies in the world to get FDA approval for INDs for use of non-expanded native SVF for osteoarthritis. Akan Bio also launched allograft HCT/P products in 2021 at more than 200 clinics nationwide with contracts to be the preferred allograft product for more than 5000 clinics in the US alone by 2022. In addition, Akan Bio is developing products for the treatment of autism and Crohn’s disease.
Another of his companies, FDAMap, has worked with more than 1100 companies of all sizes over the last 6 years including several Fortune 100 and Fortune 500 pharmaceutical, biotech, medical devices and digital health, and healthcare companies. He is one of the world’s top experts in US regulatory affairs, compliance, clinical trials, and smart product development strategies. His clients are in more than 50 countries in the Americas, Europe, Asia, Africa, and Australia. He has been pivotal in the development of more than 100 medicinal and diagnostic products with more than 200 clinical trials, thousands of submissions to the US FDA, European Medicines Agency, and regulators in about 34 countries. His approach of disruptive product development is based on using novel, smart, out-of-the-box regulatory approaches that expedite patient access while reducing development cost.
Mukesh sits on the Board of several small and medium size companies developing innovative products prominent among which are Vivacelle Bio, Inc. of Kansas, ResQ Pharma, Inc, of Illinois, Kibow Pharmaceuticals, Inc. of Pennsylvania, Amarex Biosciences, Pvt Ltd of New Delhi, India, and Pepfactor, Inc. of Sydney, Australia.
In addition to running companies, Mukesh is an accomplished author and thought leader in healthcare related topics having written numerous articles in peer-reviewed journals and other professional publications. His weekly blog, FDA Puran, is subscribed by over 100,000 readers globally, and he has authored more than 800 blogs on US and worldwide healthcare regulations. Mukesh loves to teach and mentor upcoming talent. He created a Certificate in Clinical Project Management at Montgomery College, Maryland, where he trained 100s of budding clinical research professionals over 8 years. He is currently a Professor (Adjunct), Regulatory Sciences, at the School of Medicine, George Washington University, Washington DC, and the lead trainer for FDAMap where he delivers about 50 lectures every year on various topics related to product development and entrepreneurship to students at all levels. He has trained more than 10,000 students over the last 20 years and personally mentored more than 100 budding scientists, developers, regulators, entrepreneurs, and policy wonks most of who have developed into successful professionals and his life-long network of experts.
Dr. Kumar is a PhD in Biochemistry, a certified regulatory professional by the Regulatory Affairs Professionals Society, USA, a certified clinical trialist by The Bloomberg School of Public Health, John Hopkins University, a Diplomate of the American Board of Regenerative Medicine, a compliance inspector, and a certifier.
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