As decentralized clinical trials are becoming mainstream, there is a need for a standard regulated framework to structure digital health technologies (DHTs) for clinical investigations. Healthcare and regulatory authorities are endeavoring to provide a digital standard for conventional use by both academic and industry clinical research centers by issuing new directive guidelines.
This webinar is intended to provide the best digital health tool practices as expected by the current thinking of the US Food and Drug Administration (FDA). To achieve adequate validation of digital health technologies, stakeholders should ensure that the technologies utilized are sufficient to support their use, function and interpretability. Factors in this validation include evaluating the clinical investigation population, design and operation of the intended digital health technology and ability to allow the use of a study participant’s own digital health technology.
The featured speaker will highlight how digital health technology items should be presented in a submission. Useful directives for validation and practicality will be outlined as well as how to evaluate clinical endpoints in the context of digital health technologies and how to proceed if a novel clinical endpoint arises when leveraging these technologies.
Digital practices should adequately measure privacy-related risks. Therefore, a primer featuring key items to examine within an Informed Consent document, that leverages digital health technologies, will also be examined. Aspects of record protection and retention, as well as sponsor’s and primary investigator’s roles and responsibilities will also be reviewed.
Register for this webinar to ensure the appropriate evaluation, inclusion and presentation of all key digital health technologies in decentralized clinical trials when submitting the next Investigational Drug Application to the FDA.
Jorge M. Rivas, MD, PhD, Director of Regulatory Affairs, US, Amador Bioscience
Dr. Jorge M. Rivas has extensive experience developing regulatory strategies for pharmaceutical, biologic and cellular/gene products for multiple indications, and across a number of regional and global pharmaceutical markets. This includes assembling meeting requests and briefing packages to meet FDA requirements such as INTERACT, Pre-IND, EOP1/EOP2 and Pre-NDA/Pre-BLA meetings. Dr. Rivas has built a successful and diversified career that includes expertise in clinical research encompassing regulatory affairs, clinical development, medical writing, drug development and translational medicine.
Who Should Attend?
- Regulatory Affairs Managers, Directors and Vice Presidents
- Clinical Development and Clinical Operations Managers, Directors and VPs.
- Clinical Trial Project Managers
- R&D Product Development Scientists
What You Will Learn
- Understand the regulator’s expectations when using digital health technologies (DHTs) to support decentralized and hybrid clinical trials
- Be able to determine how to adequately include and present a DHT within the pipeline of products when filing them for submission
- Be able to evaluate a DHT for optimal design and operation in a specific study population
- Learn how to minimize privacy-related risks and maximize record protection and retention when using a DHT
With highly experienced regulatory experts in the United States, Europe, and China, we are an extension of your regulatory team. Let us streamline your product development with cutting-edge regulatory strategies, author your important regulatory documents, and manage interactions with regulators for a smooth development process. Our goal is to establish a clear channel of communication with regulatory reviewers aiming to ensure that the investigational product pathway plan correctly anticipates what the regulatory authorities will require for optimal product development. Every program at Amador is supervised by a dedicated translational project manager who keeps deliverables and timelines on task for a successful IND submission and preparation to enter the clinic. When you meet with our team, you meet directly with our experts to make decisions, solve problems, and align cross-functionally.