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Wednesday, June 26 • 4:15pm - 5:30pm
#393: Case Studies in Resolving Quality Issues

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-715-L04-P; CME 1.25; IACET 1.25; RN 1.25

Getting a drug approved is challenging, but it is even harder when the drug developer or manufacturer is inexperienced with regulatory agencies, the process following an inspection, and expectations from regulatory authorities. This session presents specific examples of how to recover from unsuccessful inspections and/or complete response action.

Learning Objectives

Identify some of the pitfalls that can happen during the drug development and initial manufacturing; Describe methodologies for resolving deficiencies in manufacturing and enhancing assurance of product quality.

Chair

Milind Ganjawala, MBA, MS

Speaker

Preparing Global CMC Dossiers when Faced with Challenging Corporate Milestones and Manufacturers Inexperienced with ICH/GMP
Duu-Gong Wu, DrSc, PhD

A Small US Drug Manufacturing Company’s Journey from Complete Response to NDA Approval
Daniel M. Bollag, PhD

FDA Update
Derek Smith, PhD



Speakers
avatar for Daniel Bollag

Daniel Bollag

Senior Vice President, Regulatory Affairs and Quality, Ocular Therapeutics
Dr. Bollag joined Ocular Therapeutix in August 2017 as Senior Vice President of Regulatory Affairs and Quality. He held a similar role at ARIAD Pharmaceuticals from 2009 - 2017 where he oversaw the accelerated registrations of ICLUSIG (ponatinib) indicated for chronic myeloid leukemia... Read More →
avatar for Derek Smith

Derek Smith

Director, Div of Inspectional Assessment, OPF, OPQ, CDER, FDA
Derek Smith is the Director of the Division of Inspectional Assessment and the Acting Associate Director for Regulatory Affairs in the Office of Process and Facilities where he oversees the assessment of the manufacturing process and facilities for biologics and small molecule drug... Read More →
DW

Duu-Gong Wu

Senior Director, Global Regulatory Affairs, PPD
Dr. Duu-Gong Wu is Senior Director of Regulatory Consulting at PPD with expertise in biosimilar regulatory and technical strategy. He previously worked at US FDA with the last position as Deputy Division Director at CDER, before joining PharmaNet/i3, then PPD. His experience included... Read More →
MG

Milind Ganjawala

Supervisory Consumer Safety Officer, OMQ, OC, CDER, FDA
Mr. Ganjawala serves as the Division Director of the Division of Drug Quality 2 (DDQ2), Office of Manufacturing and Product Quality (OMPQ), Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), FDA. Prior to coming to FDA, Mr. Ganjawala spent more than 20 years... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA