Regulatory Affairs and Quality Committee (RAQC)
Supported by and working closely with the PDA Quality and Regulatory Affairs Department is the PDA Regulatory Affairs and Quality Committee (RAQC). The RAQC is a critical source for identifying global regulatory issues of interest to PDA members globally.
Once a regulatory issue is identified, the RAQC forms a Task Force to study and prepare written comments. The list of recommendations they prepare, PDA Regulatory Comments, is then submitted back to the originating agency/organization (i.e., FDA, EMEA, WHO, etc.) for review/inclusion and consideration for inclusion into a the final guidance regulatory document. PDA Regulatory Comments are also posted to the PDA Web site for public viewing and are highlighted monthly in the PDA Letter.
Regulatory Affairs and Quality Committee Members
CHAIR (Voting)
Dr. –Ing. Stephan Rönninger
Head of External Relations, Europe/Japan
External Relations and Collaboration (PTQR)
F. Hoffmann-La Roche Ltd.
Grenzacher Strasse
Building 657/28.030
Postfach, CH-4070 Basel Switzerland
Phone: +41-61-68-86-974
Fax: +41-61-68-82-610
Stephan.roenninger@roche.com
CO-CHAIR (Voting)
Ms. Susan J. Schniepp
Vice President of Quality
OSO Biopharmaceuticals Manufacturing LLC
4401 Alexander Blvd NE
Albuquerque, NM 87107 USA
Phone: +1-978-399-8930
susan.schniepp@osobio.com
| Canada Regional Leader |
Mr. Jeffrey R. Broadfoot
Cangene Corporation
155 Innovation Drive
Winnipeg MB R3T 5Y3
CANADA
Title: Director, Quality Assurance
Phone: +1-204-275-4027
Fax: +1-215-275-4298
Email: jeff_broadfoot@cangene.com |
|
| North American Regional Leader |
Mr. Alan C. Burns
Sartorius-Stedim Biotech
1910 Mark Court
Concord, CA 94520-8529 USA
Title: Vice President, Global Quality
Phone: +1-925-689-6650 ext. 258
Fax: +1-925-689-6988
Email: alan.burns@sartorius-stedim.com |
|
| Australia Regional Leader |
Mr. Robert B. Caunce
Hospira
1 Lexia Place
Mulgrave, Melbourne 3170
AUSTRALIA
Title: Quality Project Manager, Quality Assurance
Phone: +61-3-8541-5870
Email: Robert_Caunce@hospira.com |
|
| Science Advisory Board Liaison |
Mr. Don E. Elinski
Lachman Consultant Services, Inc.
1600 Stewart Avenue
Westbury, NY 11590 USA
Title: Senior Associate
Phone: +1-516-222-6222
Fax: +1-516-683-1887
Email: d.elinski@lachmanconsultants.com |
|
| Program Advisory Board Liaison |
Ms. Louise Johnson
Aptuit
2 Greenwich Office Park
Stamford, CT 06831 USA
Title: Vice President, Quality
Phone: +1-203-524-4214
Email: louise.johnson@aptuit.com |
|
| Immediate Past Chair |
Mr. Steven Mendivil
Amgen, Inc.
1 Amgen Center Drive
MS-92-2-C
Thousand Oaks, CA 91320-1799 USA
Title: Executive Director, GMP External Affairs
Phone: +1-805-313-1622
Fax: +1-805-480-0749
Email: stevenm@amgen.com |
|
| European Regional Leader |
Dr. –Ing. Stephan Rönninger
F. Hoffmann-La Roche Ltd.
Building 657/23/020
Postfach, CH-4070 Basel
SWITZERLAND
Title: Head of External Relations, Europe/Japan
Phone: +41-61-68-86-794
Fax: +41-61-68-88-892
Email: stephan.roenninger@roche.com |
|
| Asia Pacific Regional Leader |
Ms. Junko Sasaki
Sumitomo Pharmaceuticals
2-8, Doshomachi 2-chome
Chuo-ku, Osaka 541-8510
JAPAN
Title: Corporate Quality Assurance
Phone: +81-662-295-502
Fax: +81-662-332-287
Email: junko-1-sasaki@ds-pharma.co.jp |
|
| PDA Training and Research Liaison |
Ms. Susan J. Schniepp
OSO Biopharmaceuticals Manufacturing LLC
4401 Alexander Blvd NE
Albuquerque NM 87107 USA
Title: Vice President of Quality
Phone: +1-505-923-2188
Email: susan.schniepp@osobio.com |
|
| Emerging Regions Liaison (BRIC) |
Ms. Janeen Skutnik
Pfizer
MS 8200-4015
Eastern Point Road
Groto, CT 06340 USA
Title: Director, Quality & Regulatory Policy
Phone: +1-860-686-3435
Email: Janeen_Skutnik@pfizer.com |
|
| Biotechnology Advisory Board Liaison |
Mr. Michael VanDerWerf
GlaxoSmithKline Biologicals
2301 Renaissance Blvd.
King of Prussia, PA 19406-2772 USA
Title: Assistant Director, U.S. Regulatory Affairs, Vaccines
Phone: +1-610-787-3766
Fax: +1-610-787-7063
Email: michael.s.vanderwerf@gsk.com |
|
| China Reqional Leader |
Ms. Hongyan Xie
Qilu Pharmaceuticals Co., Ltd.
No. 243 Gongyebei Road
Shandong, Jinan CHINA
Phone: +86-531-26268
Email: Hongyan.xie@qilu-pharm.com |
|
RAQC Members
|
Ruhi Ahmed, Ph.D.
BioMarin Pharmaceuticals, Inc.
105 Digital Drive
Novato, CA 94949-8703 USA
Title: Director, Regulatory Affairs
Phone: +1-415-506-6735
Fax: +1-415-506-6306
Email: rahmed@bmrn.com |
|
|
John D. Finkbohner, Ph.D.
MedImmune
One MedImmune Way, Room 1238
Gaithersburg, MD 20878-2204 USA
Title: Director, Regulatory Affairs, Vaccines
Phone: +1-301-398-4560
Fax: +1-301-398-9560
Email: finkbohnerj@medimmune.com |
|
|
Ms. Amy Giertych
Baxter Healthcare Corporation
25212 W. IL Route 120, WG2-3
Round Lake, IL 60085-6358 USA
Title: Senior Director, Global Regulatory Affairs
Phone: +1-847-270-4158
Fax: +1-847-270-4119
Email: amy_giertych@baxter.com |
|
|
Ms. Karen Ginsbury
PCI Pharmaceutical Consulting Israel LTD.
Hibner 1/3, Petah Tikva 49400 ISRAEL
Title: President
Phone: +972+(0)3+9213878
Fax: +972+(0)+3+9214097
Email: kstaylor@netvision.net.il |
|
|
Mr. Shin-ichiro Mohri
Kyowa Hakko Kirin Co., Ltd.
1-1-53 Takasu-cho
Sakai-ku Sakai-city
Osaka 590-8554 JAPAN
Title: Director, Sakai Plant
Phone: +81-0-72-223-5554
Fax: +81-0-72-227-7214
Email: shin-ichiro.mohri@kyowa-kirin.co.jp |
|
|
Dr. Siegfried Schmitt
PAREXEL Consulting
The Quays
101-105 Oxford Road
Uxbridge, Middlesex UB 1LZ
United Kingdom
Title: Principal Consultant
Phone: +44-7824-592401
Fax: +44-1895-614584
Email: Siegfried.Schmitt@parexel.com |
|
|
Mrs. Jacqueline Veivia-Panter
Abbott Laboratories
10 Cambridge Avenue
Denville, NJ 07834-9649 USA
Title: Director, Quality
Phone: +1-973-986-9685
Email: Jacqueline.Veivia@abbott.com |
|
|
Ms. Barbara B. Zinck
Zinck Consulting
310 Fairtree Drive
Severna Park, MD 21146 USA
Title: President
Phone: +1-410-371-8273
Email: Barbara.Zinck@gmail.com |
|
| PDA Staff Liasion (Non-Voting) |
Mr. Robert L. Dana
PDA Global Headquarters
Bethesda Towers
4350 East West Hwy., Suite 200
Bethesda, MD 20814 USA
Title: Senior Vice President, Regulatory Affairs and PDA Training and Research Institute
Phone: +1-301-656-5900
Fax: +1-301-986-0296
Email: dana@pda.org |
|
Mr. James C. Lyda
PDA Europe
5471 Crescent View Parkway
Raleigh, NC 27606-4520 USA
Title: Director, Regulatory Affairs Europe
Phone: +1-919-809-2411
Email: lyda@pda.org |
|
Ms. Iris D. Rice
PDA Global Headquarters
Bethesda Towers
4350 East West Hwy., Suite 200
Bethesda, MD 20814 USA
Title: Manager, Scientific & Regulatory Affairs
Phone: +1-301-656-5900
Fax: +1-301-986-0296
Email: rice@pda.org |
|