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The Role of OUS Clinical Studies

Malvina B. Eydelman, MD give her presentation on some of the newest directions coming out of the FDA for device studies in the US followed by a panel discussion on clinical studies in the US vs. clinical studies overseas.

Moderator:

Gilbert-Kliman

Gilbert H. Kliman, MD

Dr. Gil Kliman leads the medical device investment team at InterWest Partners and invests in a broad array of healthcare opportunities, with a special interest in ophthalmology and digital health.

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Panelists:

Aron Shapiro

Aron Shapiro

Aron Shapiro is a Vice President at Ora, Inc., the world’s leading independent, full-service ophthalmic CRO and product development firm. He has served as a member of Ora’s Senior Management Team for the past 15 years.

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Malvina-Eyedelman

Malvina B. Eydelman, MD

Dr. Eydelman joined FDA in 1995 and for the last 17 years, has served as the Director of FDA’s Division of Ophthalmic and Ear, Nose and Throat Devices (DOED), and subsequently Director of the FDA’s Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices (DONED).

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Matteo Piovella

Matteo Piovella

Piovella was born in Como, and completed his undergraduate studies in Pavia, where he graduated in Medicine and Surgery specializing in Clinical Ophthalmology.

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Roberto Zaldivar

Roberto Zaldivar

Roberto Zaldivar was born in New Haven Connecticut in 1957 during Prof. Dr. Roger Zaldivar’s (father) post graduate training at Yale University.

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Michael Mrochen

Michael Mrochen, PhD

Michael Mrochen, PhD co-founded ClearSight Innovations in 2013. He is responsible for the product development as CTO.

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Donald Tan

Donald Tan, MD

Professor Donald Tan is Director of the Singapore National Eye Centre, Chairman of the Singapore Eye Research Institute till year 2013, tenured full professor of the Ophthalmology at the National University of Singapore, and chair of the Eye Academic Clinical Program at the Duke-NUS Graduate Medical School.

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