Learning Tracks

Device Differences: Challenges and Opportunities

Monday, October 2, 2023

11:15 a.m. - 12:15 p.m.

This session will discuss the assessment of user interface differences, identification of when additional information may be needed, and discuss common deficiencies related to device differences to be aware of during product development. Information will also be provided on how to engage with FDA through the pre-ANDA program to raise questions regarding device differences.

Speakers:

Karyn Berry, MD, MPH
Medical Officer, Division of Clinical Review, OSCE, OGD, CDER, FDA

Chris Lamanna, PhD
Head Regulatory Devices, Sandoz

Markham Luke, MD, PhD
Division Director, Division of Therapeutic Performance I, ORS, OGD, CDER, FDA

Ripen Misri, PhD
Director, Co-Development, Apotex Inc.

Raveendra Pai, MPharm, PhD
Senior Vice President – Formulation Development, Glenmark Pharmaceuticals Ltd.

Ke Ren, PhD
Deputy Division Director, Division of Bioequivalence III, OB, OGD, CDER, FDA