DC/ Baltimore Chapter: FDA Compliant Use of Smartphones, Apps and Technology in Clinical Trials

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Wednesday, 22 February 2023 (11:00 AM) - Wednesday, 22 February 2023 (12:00 PM) Eastern Time (US & Canada)

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.


REGISTRATION FEES 

13 January 2023 - 22 February 2023: Regular $0 Member | $25 Non-Member


Learning Objectives

  • Review devices and applications used in clinical trials
  • Understand FDA expectations for validation, user instructions and monitoring practices
  • Discuss approaches for incorporating data captured by smart devices into CRF and source documents
  • Discuss practical concerns and considerations for BYOD trial design and multinational clinical trials
  • Explore approaches for auditing and monitoring smart device usage in clinical trials

  • Audience Learning Level

    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.

    Who Should Attend?

    Regulatory affairs professionals involved in clinical trials, biologics and devices.


    Instructors:

    Mukesh Kumar

    Mukesh Kumar

    Dr. Mukesh Kumar is an accomplished serial entrepreneur, senior executive, author, thought leader, public speaker, and advisor to management teams and BODs with more than 18 years of across healthcare industry success. He is the founder of Akan Biosciences and FDAMap, two Maryland-origin companies.

    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.

    Cancellations

    RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

    All cancellation requests must be submitted in writing to raps@raps.org.  RAPS is unable to accept cancellations by phone.

    To transfer a registration, email raps@raps.org with the event title, name of the original registrant, and contact information for the new attendee.


    Proof of Attendance

    A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

     

    Questions

    For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

    For account support, contact the RAPS Support Center: at +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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