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Learning Tracks

Combination Products & Similarity

Tuesday, November 9, 2021

12:00 p.m. - 1:30 p.m.

This session will explore device considerations when comparing generic combination products with the RLD and what qualitative and quantitative methods could be used for assessing the comparability of generic drug-device combination products. This session will also explore current thinking with respect to device related considerations for biosimilars.

Moderator: Markham Luke, M.D., PhD
Director, Division of Therapeutic Performance I, ORS, OGD, CDER, FDA

Karthik Balasubramanian, PhD
Director, Generic CPD, US Development and Commercial, Teva Pharmaceuticals

Lisa Bercu, JD
Regulatory Counsel, Division of Policy Development, OGDP, OGD, CDER, FDA

Sharon Kovacs
Program Manager, Co-Development, Apotex Inc.

Sarah Yim, M.D.
Director, OTBB, OND, CDER, FDA


CAPT Irene Chan, PharmD, BCPS 
Acting Director, Division of Medication Error Prevention and Analysis 1, Office of Medication Error Prevention and Risk Management (OMEPRM), OSE, CDER, FDA

Dhaval Gaglani, MS
Branch Chief, Division of Immediate and Modified Release Products III, Office of Lifecycle Drug Products, OPQ, CDER, FDA

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