Regulatory Affairs/Quality Advisory Board (RAQAB)

The mission of the PDA Regulatory Affairs and Quality Advisory Board (RAQAB) is to serve the PDA membership by influencing scientific-based regulations and providing interpretation on quality and regulatory issues affecting development, manufacturing and control of healthcare products. This encompasses many areas including FDA, EMA other global Regulatory Authorities and/or applicable bodies.

For more information about the RAQAB, contact Iris D. Rice, Manager, Scientific and Regulatory Affairs at rice@pda.org.

Regulatory Affairs and Quality Advisory Board Members

CHAIR
Dr. – Ing. Stephan Rönninger
Head of External Collaboration, Europe/Japan/CEMA
Global Quality, Compliance and External Collaboration
F. Hoffmann-La Roche, Ltd.

VICE CHAIR
Ms. Susan J. Schniepp
Vice President of Quality
OSO Biopharmaceutical Manufacturing LLC

Ruhi Ahmed, Ph.D., RAC Senior Director, Regulatory Affairs Ultragenyx Pharmaceutical, Inc.	PDA SCIENCE ADVISORY BOARD LIAISON Mr. Don E. Elinski Senior Associate Lachman Consultant Services, Inc.
CANADA REGIONAL LEADER Mr. Jeffrey Broadfoot Director, Quality Assurance Cangene Corporation	John D. Finkbohner, Ph.D. Senior Director, Regulatory Affairs MedImmune
UNITED STATES REGIONAL LEADER Mr. Alan C. Burns Vice President, Global Quality Sartorius-Stedim Biotech	Ms. Amy Giertych Senior Director, Global Regulatory Affairs Baxter Healthcare Corporation
AUSTRALIA REGIONAL LEADER Mr. Robert B. Caunce Quality Manager, Technology Transfer Hospira	Ms. Karen Ginsbury CEO PCI Pharmaceutical Consulting Israel Ltd.
Dr. Barbara Jentges Managing Director, Regulatory Affairs PhACT GmbH	EUROPEAN REGIONAL LEADER Dr. – Ing. Stephan Rönninger Head of External Collaboration, Europe/Japan/CEMA Global Quality, Compliance and External Collaboration F. Hoffmann-La Roche, Ltd.
Ms. Louise Johnson Senior Vice President, Global Development Quality Assurance Takeda Pharmaceuticals International, Inc.	ASIA PACIFIC REGIONAL LEADER Ms. Junko Sasaki Quality Principal, Investigational Drug Quality Dainippon Sumitomo Pharma
IMMEDIATE PAST CHAIR BOARD OF DIRECTORS LIAISON Mr. Steven Mendivil Executive Director, Corporate Quality External Affairs Amgen, Inc.	Dr. Siegfried Schmitt Principal Consultant PAREXEL Consulting
Mr. Shin-ichiro Mohri Director, Sakai Plant Hyowa Hakko Kirin Co., Ltd.	PDA TRAINING AND RESEARCH LIAISON USP PHARMACOPEIA LIAISON Ms. Susan J. Schniepp Vice President of Quality OSO Biopharmaceutical Manufacturing LLC
BIOTECHNOLOGY ADVISORY BOARD LIAISON Mr. Michael S. VanDerWerf Associate Director, U.S. Regulatory Affairs, Vaccines GlaxoSmithKline Biologicals	Mrs. Jacqueline Veivia-Panter Director, Quality Abbott Laboratories
CHINA REGIONAL LEADER Ms. Hongyan Xie Deputy General Manager for Regulatory Affairs Qilu Pharmaceuticals Co., Ltd.	Ms. Barbara B. Zinck President Zinck Consulting

PDA STAFF LIAISON

Mr. Robert L. Dana
Senior Vice President, Regulatory Affairs and PDA Training and Research Institute
PDA Global Headquarters

Mr. James C. Lyda
Senior Scientific Advisor for Scientific & Regulatory Affairs
PDA Global Headquarters

Ms. Iris D. Rice
Manager, Scientific & Regulatory Affairs
PDA Global Headquarters

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