Larger Than Life Science is a free monthly event series open to everyone interested in building a strong support network for North Carolina’s life science and healthcare innovators.
This month's theme: Let’s Get Clinical: Preparing your company for the regulatory hurdles ahead
Your idea is awesome, you’ve got the right people, your funding picture is falling into place. What’s next? Proving it works! What steps should you be making or anticipating now to be ready for the scrutiny of regulators on both sides of the ocean?
The European Union is making a major upgrade to its Medical Device Regulations (MDR). The new rules, designed to increase patient safety by making products easier to trace, take effect in May 2020. Device developers and manufacturers will face greater responsibilities for electronic reporting, device labeling and data sharing and your team will need to adapt. Join us for this interactive discussion on the major regulatory changes taking effect in a few months, and learn what you need to do now to prepare.
At what point in the process should a biotech business think about clinical trial study designs that will carry their idea through FDA approvals? When and how should they retain the services of a Clinical Research Organization to help them along? Join us for a conversation with one CRO, Celerion, and one of their clients, Bryn Pharma.
NC State’s ASSIST Center is powering health informatics through wearables. ASSIST’s nanotechnology-enabled energy harvesting and storage, ultra-low power electronics, and embedded sensors create innovative, battery-free, body-powered, and wearable health monitoring systems. See the future of healthcare with ASSIST researchers who will share and demo some of their technologies.
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