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Thursday, June 28 • 10:45am - 12:00pm
#416: FDA Town Hall

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-697-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will include discussions and updates from FDA leadership 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

Sudip Parikh, PhD

Speaker

Panelist
Janet Woodcock, MD

Panelist
Peter W. Marks

Panelist
Tamy Kim, PharmD



Speakers
avatar for Tamy Kim

Tamy Kim

Associate Director for Regulatory Affairs, OHOP and OCE (Acting), CDER, FDA
Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including... Read More →
avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →
avatar for Sudip Parikh

Sudip Parikh

Senior Vice President and Managing Director, DIA Americas, DIA
Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial... Read More →
avatar for Janet Woodcock

Janet Woodcock

Director, Center for Drug Evaluation and Research, FDA
In 2015, Dr. Woodcock also operated in the role of Acting Director of CDER’s newly formed Office of Pharmaceutical Quality, (OPQ). Dr. Woodcock joined CDER in 1994. From 2005 - 2008, she served in FDA’s Commissioner’s office, holding several positions, as Deputy Commissioner... Read More →


Thursday June 28, 2018 10:45am - 12:00pm
Room 210AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA