Slides for the August 5, 2009 Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee

FDA Master Slide (pdf)

TOPIC 1

 

Dale P. Conner, Pharm.D. (pdf)

Director, Division of Bioequivalence 1

OGD, CDER, FDA

 

 

TOPIC 2

 

Nakissa Sadrieh, Ph.D. (pdf)

Associate Director for Research Policy and Implementation

Office of Pharmaceutical Science, CDER, FDA

 

Bozena Michniak-Kohn, Ph.D., M.R.Pharm.S.  (pdf)

Professor in Pharmaceutics

Lab. for Drug Delivery,

NJ Center for Biomaterials

Ernest Mario School of Pharmacy-Rutgers

 

Ravi Harapanhalli, Ph.D.  (pdf)

Principal Consultant and Director (Late Stage Service Line)

PAREXEL Consulting

 

TOPIC 3

 

David Hussong, Ph.D.  (pdf)

Associate Director

OPS/NDMS, FDA

 

Michael Jhung, M.D., M.P.H.  (pdf)

Division of Healthcare Quality Promotion

Centers for Disease Control and Prevention

 

Christina Chang, M.D., M.P.H.  (pdf)

Division of Nonprescription Clinical Evaluation

Office of Nonprescription Products, CDER, FDA

 

Karen Hirshfield, R.Ph. (pdf)

Recall, Shortage, and Emergency Coordinator
Office of Compliance, CDER, FDA

 

Open Public Hearing (pdf)

 

 

TOPIC 4

 

Moheb Nasr, Ph.D.   (pdf)

Office of New Drug Quality Assessment

OPS/CDER/FDA

 

Robert Baum, Ph.D.  (pdf)

Pfizer Global Research & Development

 

Jean M. Wyvratt, Ph.D.  (pdf)

Merck & Co., Inc.

 

Swroop Sahota, Ph.D., M.B.A (pdf)

Vice-president, Global Quality Services

Schering-Plough