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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