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Done and Dusted - FDA Approvals

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A*StartCentral - ETPL's Co-innovation Space

79 Ayer Rajah Crescent

#05-03

Singapore, 139955

Singapore

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Although traditional medical device hardware still plays a prominent role in our health care system, the current advances in computational power and new digital platforms are redefining the way modern care is accessed and administered. FDA has been grappling with regulation of rapidly advancing digital products which includes artificial intelligence. From mobile medical applications and "software as a medical device" to advanced analytics and artificial intelligence, digital products now make up a sizeable portion of the device economy. These products have brought new market participants, who have in turn brought innovation and new manufacturing processes that don't fit neatly into existing regulatory space.

In this presentation, the focus will be on key aspects of FDA regulation of software as a medical device. In addition to the basic regulatory issues for all regulated devices (e.g., classification, paths to market), this presentation will provide recent updates in the FDA regulation of software devices. Other topics will include global regulatory planning and building effective FDA submissions

About the speaker:

Professor Alan Donald is a regulatory expert with a proven record of successes in regulatory affairs and related areas in a broad range of regulated products. He has over 30 years in consulting and executive management teams with proven success in large, small and startup companies. His regulatory and product development expertise include Class III devices and combination (drug/biologics and device) products. He possesses deep knowledge of regulatory science and U.S. Food and Drug Law and has a strong medical sciences background. His key strength is his ability to navigate complex regulatory and compliance issues involving multiple stakeholders. Professor Alan Donald teaches at the Center for Bio/Pharmaceutical and Biodevice Development, San Diego State University in the Master’s in Regulatory Affairs Program.

Program and Schedule:

11.00am to 1.00pm Talk

1.00pm to 2.30pm Lunch and Networking


Please contact ask_asc@etpl.sg for further enquires.

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Location

A*StartCentral - ETPL's Co-innovation Space

79 Ayer Rajah Crescent

#05-03

Singapore, 139955

Singapore

View Map

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