This course features the most robust evidence, best practices, and guiding principles. Content is based on DiMe-generated research and other high-quality sources such as relevant regulatory guidance. Learn about the latest and greatest in digital medicine from the very best — poising your organization and your teams for professional and business success. Note: This course is only available as an enterprise license. While the course is broadly applicable to anyone working in an R&D organization within pharma, there are a few stakeholder groups that might see greater value in the course concepts: Clinical study managers / CTPMs Process leads within clinical design, development, or operations IT or systems administrators overseeing clinical systems or processes Digital health professionals within large trial sponsor organizations Measurement scientists or scientists working with COAs/PROs Leaders of decentralized trial programs or capabilities Topics include: The first steps: What is digital medicine and why does it matter Digital landscape: The importance of digital, current landscape and trends shaping market A window of opportunity: Leveraging digital to accelerate and scale clinical trials The participant-first approach: Driving participant-centricity by integrating inclusivity and personalized development Managing Privacy, and Security: foundational elements of building trust  Putting it into practice: Digitalization of clinical trials  Standard Price: Pricing is based on the organization's revenue size; contact DiMe for additional information on the rate card.  Discount Price: BIO Members receive a discount of 50% off the rate card. To request the discount, BIO members should email courseshelp@bio.org with the following: The BIO Member Company's name, city, state/province, and country The Course Registrant's full name and email address The Course Title

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. While this course applies to anyone focused on developing digital health products, the following learners may find the course particularly valuable: Product managers, program leads, and clinical R&D specialists focused on building digital health products Regulatory affairs or regulatory strategy professionals, particularly those focused on digital health Senior leaders and decision makers leading digital health organizations Quality engineers and professionals Engineer(s) and designers building or updating digital health products Junior associates at VC firms/investor community  Topics include: The ‘why’: Why a fit-for-purpose regulatory strategy is essential for business success. The basics: Current (and evolving) landscape of digital health product regulation by FDA – what should you know? The ‘what’: What are the components of a fit-for-purpose regulatory strategy?  Optimizing your regulatory strategy for success over time. The ‘how’: How to implement your regulatory strategy for optimal success? The impact: How do robust regulatory strategies build trust?  BIO Members receive a discounted rate for course registration. To request the discount code, BIO members should email courseshelp@bio.org with the following: The BIO Member Company's name, city, state/province, and country The Course Registrant's full name and email address The Course Title