What Can Industry and FDA do to tackle Nitrosamine Impurities?
Wednesday, October 4, 2023
10:00 a.m. - 11:30 a.m.
Newly discovered nitrosamine impurities present challenges for industry to finalize an acceptance limit, their control, and evaluation in API/FP. This session will discuss guidance for analytical methods and control limits, how FDA and industry can collaborate to tackle these challenges, and what FDA, global regulators, and industry are doing to address the presence of nitrosamines in drug products, including setting acceptable limits in light of advancing detection methods, and the scientific and policy implications of various approaches, including a framework for bioequivalence and biowaivers for reformulated products.
Speakers:
Sanjeeva Chinnakadoori, M.S.
Research Scientist III, Analytical R&D, Amneal Pharmaceuticals
Martin Ehlert, PhD
Vice President, Global API Technical, Apotex Inc.
Naomi Kruhlak, PhD
Scientific Lead, Division of Applied Regulatory Science, OCP, OTS, CDER, FDA
Jennifer Leaming, RAC
Principal Consultant, Lachman Consultant Services, Inc.
Dongmei Lu, PhD
Policy Lead, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA
Andre Raw, PhD
Associate Director, Immediate Office, OLDP, OPQ, CDER, FDA
Kalpana Vanam, MBA
Senior Vice President, Regulatory Affairs, Lupin Pharmaceuticals, Inc.
Liang Zhao, PhD
Division Director, Division of Quantitative Methods & Modeling, ORS, OGD, CDER, FDA
Panelists:
Rebecca Cambronero, MBA, MSL, PMP
Senior Director, Regional General Manager, North America, U.S. Pharmacopeia
Reynolds (Rey) Cantave, PharmD
Senior Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA
Sruthi King, PhD
Deputy Division Director, Division of Pharmacology and Toxicology, OSCE, OGD, CDER, FDA
Bhagwant Rege, PhD
Division Director, Division of Biopharmaceutics, ONDP, OPQ, CDER, FDA
Diaa Shakleya, PhD
Senior Research Scientist, DPQR, OTR, OPQ, CDER, FDA
Rong Wang, PhD, PharmD
Associate Director, Division of Bioequivalence I, OB, OGD, CDER, FDA
Moderator:
Kristin Willemsen
Vice President, Scientific & Regulatory Affairs, Canadian Generic Pharmaceutical Association
