Science and Regulatory Affairs
Science Advisory Board (SAB)
The SAB establishes the strategic direction and provides oversight for PDA's scientific and technical activities through the development of guidelines, technical reports, and technical bulletins and recommendations of other activities such as conferences or training courses.
Through its sister Advisory Boards, RAQAB and BioAB, the SAB, interacts with regulatory authorities by participating in the development of responses to regulatory draft and final guidance and directives.
For more information about the PDA Science Advisory Board, contact Iris Rice, Manager, S&RA Department at PDA.
PDA Science Advisory Board Members
CHAIR
John G. Shabushnig, Ph.D.
Senior Manager, Global Quality Operations
Pfizer Inc.
VICE-CHAIR
Mr. Harold S. Baseman
Chief Operating Officer and Principal
Valsource, LLP
| Advisory Board Members | |
|
Raphael Bar, Ph.D. |
Joyce E. Bloomfield |
| Jean-Luc Clavelin Retired Formerly of Lilly France S.A.S. |
Phil DeSantis DeSantis Consulting Associates |
| Jens E. Eilertsen, Ph.D. Senior Principal Scientist Novo Nordisk A/S |
Don E. Elinski Senior Associate Lachman Consultants |
| Kristen D. Evans Director, Global Quality Compliance Amgen, Inc. |
Tor Gråberg Head of Inspection Medical products Agency |
| Maik W. Jornitz Senior Vice President, Marketing & Product Management Sartorius Stedim North America Inc. |
Joachim Leube, Ph.D. Senior Director, Quality Compliance Crucell Holland B.V. |
| Michael A. Long, Ph.D. Director and Principal Consultant Concordia ValSource |
Russell E. Madsen President The Williamsburg Group, LLC |
| Walter De Matteo Manager, Microbiological Laboratory Lily France S.A.S. |
Grace E. McNally Consumer Safety Officer, CDER United States Food and Drug Administration |
| Jeanne E. Moldenhauer, Ph.D. Vice President Excellent Pharma Consulting |
Christopher J. Smalley, Ph.D. Associate Director, BioSterile Validation Merck & Co., Inc. |
| Brenda W. Uratani, Ph.D. CGMP Compliance Officer United States Food and Drug Administration |
Glenn E. Wright Senior Director, Project Management Eli Lilly and Company |
| PDA Staff Liaison | |
| Richard V. Levy, Ph.D. Senior Vice President, Scientific & Regulatory Affairs PDA Global Headquarters |
Georg Roessling, Ph.D. Senior Vice President, European Operations PDA Europe |
| Iris D. Rice Manager, Scientific & Regulatory Affairs PDA Global Headquarters |
|