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Science Advisory Board (SAB)

The PDA Science Advisory Board (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. Through its sister Advisory Board, RAQC, the SAB, interacts with regulatory authorities by participating in the development of consensus responses to regulatory draft and final guidance and directives.

The Chair of the SAB is appointed by the Chair of PDA and approved by the PDA Board. The SAB Chair may be replaced at any time by agreement of a simple majority of the PDA Board. Other SAB leadership positions include a Vice-Chair, who will assume the duties of the Chair in the event the Chair is unable to fulfill his/her responsibilities. The Vice-Chair is nominated by the SAB Chair, and the nomination must be ratified by the PDA Board.

The SAB is composed of individuals who have a demonstrated history of scientific and technical excellence within the scope of PDA's activities. SAB membership must be approved by the PDA Board. Currently there are over 20 individuals on the SAB, drawn from industry, government, and academia.

For more information about the PDA Science Advisory Board, contact Iris Rice, Manager, S&RA Department at PDA.

PDA Science Advisory Board Members

CO-CHAIR (Voting)

Mr. Harold S. Baseman
Chief Operating Officer and Principal
Valsource, LLP
6416 Wood Creek Court
Jupiter, FL 33458 USA
Phone: 561-676-3940
Email: hbaseman@valsource.com

CO-CHAIR (Voting)

Jens H. Eilertsen, Ph.D.
Senior Principal Scientist
Novo Nordisk A/S
Nybrovej 80, JHE/NYA1.07, Ge.
Gentofte, DK-2820
DENMARK
Phone: +45-444-22558
Fax: +45-444-28799
Email: jhe@novonordisk.com

Advisory Board Members Members (Voting)
Raphael Bar, Ph.D.
Pharmaceutical Consultant
BR Consulting
Menuha Venahala St. 49/13
Rehovot, 76257
Phone: +972-8-9364281
Email: rbar@netvision.net.il
Ms. Joyce E. Bloomfield, MT, ASCP
Executive Director, Global GMP Systems & Compliance
Merck & Co., Inc.
209 North Hamilton Street
Doylestown, PA 18901 USA
Phone: 215-652-6202
Email: joyce_bloomfield@merck.com
Mr. Jean-Luc Clavelin
Senior Quality Assurance Consultant
Lilly France S.A.S.
Zone Industrielle, 2 rue du Colonel Lilly
Fegersheim F-67640 FRANCE
Phone: +33-3-90-64-41-40
Fax: +33-3-90-64-43-32
Email: clavelin_jean-luc@lilly.com
Mr. Don E. Elinski, RPh
Senior Associate
Lachman Consultants, Inc.
1600 Stewart Avenue
Westbury, NY 11590 USA
Phone: 516-222-6222
Fax: 516-683-1887
Email: d.elinski@lachmanconsultants.com
Roger Dabbah, Ph.D.
Email: rdabbah@verizon.net
Mr. Kristen D. Evans
Director, Global Quality Compliance
Amgen
175 Cherry Lane
Doylestown, PA 18901 USA
Phone: 215-345-7015
Fax: 215-489-5426
Email: kris.evans@amgen.com
Dr. Klaus Haberer
Partner and Managing Director of Compliance Advice
Microbiology, GmbH, Köln
Robert-Perthel-Straβe 49
D-50739 Köln GERMANY
Phone: +49-0-221 / 95-74-57-0
Fax: 49-0-221 / 95-74-87-25
Email: Haberer@compliance-asim.de
Lothar Hartmann, Ph.D.
Head of External Relations, Global Quality
F. Hoffmann-La Roche Ltd.
Grenzacherstr, 124
Dept. PTQ, Bldg. 657 / 23 016
Basel, 4070 SWITZERLAND
Phone: +41-616-881-878
Fax: 41-616-888-892
Email: Lothar.hartmann@roche.com
Mr. Karl L. Hofmann, Jr.
President
Hiland Pharmacon, LLC
3527 Ransom Road
Jamesville, NY 13078 USA
Phone: 315-469-7262
Email: hofmannk1@gmail.com
Stefan Köhler
Director, manufacturing Sterile, aseptic technology
AstraZeneca Sweden Operations
Södertälje SE-151 85
SWEDEN
Phone: +46-8-553-260-00
Fax: +46-70-398-64-43
Email: Stefan.Kohler@astrazeneca.com
Dr. Michael A. Long
Managing Director
KPM International Associates
Pharmaceutical and Medical Device Consulting
241 Boston Post Road, Suite 4
Wayland, MA 01778
Phone: 508-207-5490
Email: Mlong@kpmint.com
Mr. Russell E. Madsen
President
The Williamsburg Group, LLC
18907 Lindenhouse Road
Gaithersburg, MD 20879 USA
Phone: 301-938-4266
Fax: 301-869-5016
Email: madsen@thewilliamsburggroup.com
Jeanne E. Moldenhauer, Ph.D.
Vice President
Excellent Pharma Consulting
404 N. Washington Road
Mundelin, IL 60060 USA
Phone: 847-414-4828
Email: jeannemoldenhauer@yahoo.com
Ken H. Muhvich, Ph.D.
Principal Consultant
Micro-Reliance LLC
P.O. Box 3548
Rock Hill, SC 29732-5548 USA
Phone: 803-324-7734
Email: kmuhvich@comporium.net
John G. Shabushnig, Ph.D.
Senior Manager, Global Quality Operations
Pfizer Inc.
Mail Stop PORT-259-085
7171 Portage Road
Kalamazoo, MI 49001 USA
Phone: 269-833-8906
Fax: 269-833-5962
Email: john.g.shabushnig@pfizer.com
Christopher J. Smalley, Ph.D.
Email: chris.j.smalley@gmail.com
Mr. Lynn Torbeck
President, Statistical Consulting
Torbeck & Associates, Inc.
2000 Dempster Place
Evanston, IL 60201-1017 USA
Phone: 847-424-1314
Fax: 847-424-1426
Lynn@Torbeck.org
Brenda W. Uratani, Ph.D.
Assistant Director, China Office
US Food and Drug Administration
People’s Republic of China
US Embassy Beijing
#17 Guanghua Road
Chaoyang District
Beijing 100600 CHINA
Phone: +86-10+8531-3660
Fax: +86-10-6532-2032
Email 1: Brenda.uratani@fda.hhs.gov
Email 2: uratanibb@state.gov
 

PDA Staff Liaison (Non-Voting)
Richard V. Levy, Ph.D.
Senior Vice President, Scientific & Regulatory Affairs
PDA Global Headquarters
4350 East West Highway
Bethesda Towers, Suite 200
Bethesda, MD 20814 USA
Phone: 301-656-5900
Fax: 301-986-0296
Email: levy@pda.org
Iris D. Rice
Manager, Scientific & Regulatory Affairs
PDA Global Headquarters
4350 East West Highway
Bethesda Towers, Suite 200
Bethesda, MD 20814 USA
Phone: 301-656-5900
Fax: 301-986-0296
Email: rice@pda.org
Georg Roessling, Ph.D.
Senior Vice President, European Operations
PDA Europe
Adalbertstr. 9
16548 Glienicke/Berlin
GERMANY
Phone: +49 (0) 33056-2377 ext. 13
Fax: +49 (0) 33056-237777
Email: Roessling@pda.org
Volker Eck, Ph.D.
Director, Science and Technology
PDA Europe
Adalbertstr. 9
16548 Glienicke/Berlin
Phone: +49 (0) 33056 23 77 ext. 10
Fax: +49 (0) 33056-237777
GERMANY
Email: eck@pda.org
 
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