Kai Kwok, PhD Senior Pharmaceutical Quality Assessor, Division of Products Quality Assessment I (DPQAI), 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
Yanira Gonzalez-Berrios, PhD Senior Chemist, Division of Product Quality Assessment VII (DPQAVII), Office of Product Quality Assessment II (OPQAII), OPQ, CDER, FDA
Martin Shimer, II, RPh Executive Director, Lachman Consultant Services, Inc.
Cristina Ausin, PhD Scientific Reviewer, Office of Therapeutic Biologics and Biosimilars (OTBB), Office of New Drugs (OND), CDER, FDA
Andrew Clerman, MD, PhD Acting Lead Physician, Division of Therapeutic Performance and Innovation (DTPI), Office of Research and Standards (ORS), Office of Generic Drugs (OGD), CDER, FDA
CDR Andrew Fine, PharmD, BCPS Senior Advisor, Division of Clinical Review, Office of Safety and Clinical Evaluation, Office of Generic Drugs (OGD), CDER, FDA
Carrie O’Donel, MS Associate Director, MS&T, External Manufacturing, Teva Pharmaceuticals
Moderator: Chris Lamanna, PhD Head Regulatory Devices, Sandoz
Generic Drug Assessment Communication Mechanisms and Strategies to Facilitate Timely Approval
John Derstine Senior Director, Regulatory Affairs, Teva Pharmaceuticals
Karen Ireland, MS, PMP, RAC-Drugs Supervisory Regulatory Health Project Manager, Division of Regulatory and Business Process Management II, OPRO, OPQ, CDER, FDA
Meenakshi Jain, MPharm Senior Director and Head of Regulatory Generics Development, Sandoz
CAPT Vince Sansone, PharmD Director, Division of Project Management, Office of Regulatory Operations (ORO), OGD, CDER, FDA
Moderator: Kiran Krishnan, PhD Senior Vice President, Global Regulatory Affairs, Apotex Inc.
Mustafa Ünlü, PhD, JD Policy Staff Director, OTBB, OND, CDER, FDA
Moderator: Alisha Sud Director, Policy, AAM
IGBA Project Update: Single Global Development for Generic and Biosimilar Medicines
James Polli, PhD Co-Director, CRCG Professor, Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics, Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy
Anna Schwendeman, PhD Co-Director, CRCG Larry and Ann Hsu Professor, Professor of Pharmaceutical Sciences, College of Pharmacy, University of Michigan College of Pharmacy
Moderator: Aaron Josephson, MS Senior Director, Global Regulatory Policy, Teva Pharmaceuticals
Evolving SUPAC for Today’s Complex Products
Umesh Pai, M.Pharm AVP, MSTG, Regulatory & Business Continuity, Sun Pharma
Tian Ma, PhD Bioequivalence Reviewer, Office of Bioequivalence, OGD, CDER, FDA
Niles Ron, PhD Supervisory Pharmaceutical Scientist, Office of Product Quality Assessment II (OPQA II), OPQ, CDER, FDA
