Learning Tracks

Panel discussion with FDA to understand current agency thinking and expectations on topics such as (i) EDDOs for products exempt from design control (e.g., some nasal sprays); (ii) EPRs vs. EDDOs; and (iii) impact of EDDO guidance on shelf life and stability testing.

Participants:
Henri Akouka
Director, Combination Product & Device, Biopharmaceutical Development and Engineering, Teva Pharmaceuticals

Bryan Newman, PhD
Lead Pharmacologist, DTPI, ORS, OGD, CDER, FDA

Sonilal Chakrapani
Associate Director Regulatory Devices, Sandoz

Kai Kwok, PhD
Senior Pharmaceutical Quality Assessor, DPQA I, OPQA I, OPQ, CDER, FDA

Juliane Lessard, PhD
Director, Division of Drug Delivery, General Hospital Devices, and Human Factors, OHT3, Center for Devices and Radiological Health (CDRH), FDA

Moderator: Katie Petscavage, PharmD
Manager Regulatory Affairs Biosimilars, Sandoz