The RegRoadmap service, provided by the Georgia CTSA, offers Georgia investigators expert advice on how to design a strategic plan that effectively navigates the FDA regulatory requirements and launches an innovation to market. The goal of the RegRoadmap initiative is to provide investigators with the knowledge and tools to reduce friction with the FDA and increase speed to market.
Developing an effective regulatory strategy is a complex process. To address varying levels of investigator regulatory fluency, the RegRoadmap service offers 3-tier regulatory strategy support:
Tier 1: Self-Guided Intro via RegCheck Learning Modules
A series of informational videos (link to videos at bottom of page) to provide you with an overview of how to draft a Regulatory Strategy, which is the foundation for a comprehensive regulatory plan that will describe the specific steps and actions needed to successfully meet Regulatory Strategy objectives.
Tier 2: Regulatory “Readiness” Consultation
Once you have created a draft regulatory strategy, you may submit a request for a consult through the “Consult Request” link below. Your plan will be reviewed by a CTSA team member and guidance will be presented during a review meeting.
Tier 3: Regulatory Assessment
Select projects that have been pre-vetted through Tier 2 are eligible for in-depth one-on-one guidance a scholarship to pay for a formal written 1 page “Regulatory Assessment”
To schedule a RegRoadmap consultation, contact Maren.Parsell@emory.edu.
This introduction to the program will address the importance of considering various regulatory and reimbursement requirements early on in the design and research process for any health care invention. We also address how the three tiers of consultation assistance will work to help you along the way to preparing your own preliminary regulatory, clinical research and reimbursement plans.
Although understanding the regulatory requirements for any health care innovation can be daunting, this module provides a step by step approach on how to determine that for your invention. We model the process around a medical device as an example, however a similar research strategy can be used to research the regulatory requirements for drugs or combination drug/devices as well.
The clinical research module will enable you to determine what protocol you are likely going to need to execute in order to achieve an approval or clearance from the Agency for your invention. Also, clinical trial management issues that typically result in delays in a trial's execution are addressed, and how to avoid them.
Digital health wearables, cell phone apps and predictive clinical decision support software has become a new high growth area in medicine. Here we address how to determine whether what you might be developing is regulated by the Agency or not; based on the recent 21st Century Cures Act legislation and the policy papers now emerging from the Agency to implement these new directives.
Although last in the series, reimbursement is something that needs to be researched right up front. Otherwise you might not do the right kind of clinical work to support eventual pursuit of reimbursement. In this video we offer some background on how the complex field of health care reimbursement works and some practical suggestions on steps to be taken to be successful in securing it.
- Submit a request for an Innovation Catalyst consult