It’s difficult for digital innovators to know how to interact with regulators, which ones, and when. This course will remove the mystery. Learn how to build a fit-for-purpose regulatory strategy that strengthens your business strategy and differentiates your product in today’s digital health market.
Identify whether digital health products in your portfolio are likely to be regulated and through which mechanisms. Build and implement a regulatory strategy that advances the success of your products. Build evidence based, high-quality products without paying for expensive consulting services.
Discover why good regulatory strategy is essential to a good business strategy.
Today’s Regulatory Landscape
What to know about the current and evolving landscape of digital health product regulation by FDA.
Elements of a Robust Strategy
Details on the components of a fit-for-purpose regulatory strategy and where to begin when building one.
Ensuring Successful Implementation
Obtain the skills necessary to implement your regulatory strategy and interact with regulators.
Meet the Instructors
Learn from DiMe experts and world class guest faculty – including legal, strategy, and security experts from industry, academia, and regulatory bodies – at the cutting edge of the most difficult ethical questions in digital health.
What to Expect from DiMe Academy
What sets us apart is why we’re known as the most trusted name in digital health innovation globally.
Interactive sessions cater to a variety of learning styles with videos, knowledge checks to test your understanding, and real-world examples.
You’re busy, and so is your team, so our courses are designed to deliver the material efficiently, but our platform is designed so you can return as many times as you need.
Digital medicine is a fast paced field. We leverage our community to deliver up to date information from actively engaged, diverse experts.
The views expressed in this course are solely those of the Digital Medicine Society (DiMe) and not the views or opinions of the FDA or anyone else. We hope that this course will help you and your business efficiently and effectively navigate regulatory requirements, but we make no guarantees. All information and materials are provided to you on an “as is” basis without any representation or warranty of any kind. This course is intended solely for general information and education purposes. It is not professional or legal advice or services. This course contains links to third party websites. These links are only for the convenience of the learner. DiMe is not responsible for any information accessed through them.