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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, United States
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 Center Director - Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →

Thursday June 30, 2016 10:45am - 12:00pm EDT
114 Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 18: Global Regulatory, Forum