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Thursday, June 30 • 10:45am - 12:00pm
#412: CDER Town Hall

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-594-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum is a roundtable discussion with FDA leadership. It will include discussion and updates on regulatory issues, and the audience will be invited to submit questions of general interest.

Learning Objectives

Discuss regulatory issues and updates to include hot topics.

Chair

Nancy D. Smith, PhD

Speaker

Panelist
Leah Christl, PhD

Panelist
Gerald J. Dal Pan, MD

Panelist
John K. Jenkins, MD

Panelist
Michael Kopcha

Panelist
Theresa M. Mullin, PhD

Panelist
Lynne P. Yao, MD



Chair
avatar for Nancy Smith

Nancy Smith

Adjunct Professor, Temple University, FDA Alumni
Nancy Smith, PhD, retired from the FDA after almost 25 years in the Center for Drug Evaluation and Research. Nancy is past-Chair of the Biopharmaceutical Section of the American Statistical Association, and she served as a DIA board member of from 2002-2008. She was Chair of the DIA... Read More →

Speakers
avatar for Leah Christl

Leah Christl

Associate Director for Therapeutic Biologics, TBBT, OND, CDER, FDA
Dr. Christl is the Director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in the Office of New Drugs in the FDA's CDER. TBBS is responsible for ensuring consistency in the scientific and regulatory approach and advice to sponsors regarding development programs for biosimilar... Read More →
avatar for John Jenkins

John Jenkins

Director, Office of New Drugs, CDER, FDA
Dr. Jenkins is Board Certified in Internal Medicine and Pulmonary Diseases by the American Board of Internal Medicine. He joined FDA in 1992 and has been Director of the Office of New Drugs since 2002.
avatar for Michael Kopcha

Michael Kopcha

Director, Office of Pharmaceutical Quality, CDER, FDA
With more than 25 years of pharmaceutical industry experience, Dr. Kopcha’s areas of expertise include formulation and process development, process validation, technology transfer, off-shoring/outsourcing, and change management. Before joining FDA, Dr. Kopcha served as vice president... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Initiatives, OCD, CDER, FDA
Principal advisor on strategy including CDER international cooperation and harmonization, application of decision science, and other initiatives. Leads FDA Patient Focused Drug Development, and heads the FDA delegation to ICH. Previous work includes leading FDA negotiations for 2002... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, FDA
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA
Lynne Yao, MD, is the Director, Office of New Drugs, Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research, US Food and Drug Administration. The Division of Pediatric and Maternal Health oversees quality initiatives within the Office of New Drugs... Read More →


Thursday June 30, 2016 10:45am - 12:00pm
114 Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA