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 sci_reg@pda.org.

PDA Science Advisory Board Members

CHAIR
John G. Shabushnig, Ph.D.
Principal Consultant
Insight Pharma Consulting LLC

VICE-CHAIR
Mr. Harold S. Baseman
Chief Operating Officer and Principal
Valsource, LLC

Advisory Board Members

Raphael Bar, Ph.D.
Pharmaceutical Consultant
BR Consulting

Joyce E. Bloomfield
Executive Director, Global GMP Systems and Compliance
Merck Sharp & Dohme Corporation

Jette Christensen
Aseptic Scientific Director
Novo Nordisk A/S

Jean-Luc Clavelin
Retired
Formerly of Lilly France S.A.S.

Walter De Matteo
Manager, Microbiological Laboratory
IBSA Institut Biochimique SA

Phil DeSantis
Principal Consultant
DeSantis Consulting Associates

Don E. Elinski
Senior Associate
Lachman Consultants
Kristen D. Evans
Director, Global Quality Compliance
Amgen, Inc.
Tor Gråberg
Head of Drug Inspectorate
Medical Products Agency - Sweden

Marsha Hardiman
Senior Manager, Biological Services
Medtronic, Inc.

Norbert Hentschel
Director global Technical QA
Boehringer-Ingelheim

Maik W. Jornitz
Chief Operating Officer
G-Con LLC
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
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.

Edward Tidswell
Research Director
Baxter

Brenda W. Uratani, Ph.D.
Consumer Safety 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
Morgan Holland
Administrative Assistant, Scientific & Regulatory Affairs
PDA Global Headquarters
 

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