Science and Regulatory Affairs

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.

RAQAB is organized by focus on US, Canada, EU and Japanese regulations as well as on developments in emerging countries like Brazil, Russia, India, and China. RAQAB also provides oversight on the regulatory Interest Groups and members are represented in various conference committees. These activities are also supported by links to other Advisory Boards and the PCMO project in PDA.

For more information about the RAQAB, contact bakers@pda.org.

Regulatory Affairs and Quality Advisory Board Members

CHAIR
Dr.-Ing. Stephan Rönninger
Head External Affairs Europe, International Quality
AMGEN (Europe) GmbH

CO-CHAIR
Ms. Susan J. Schniepp
Vice President of Quality
Allergy Labs 

Ruhi Ahmed, Ph.D., RAC
Senior Director, Regulatory Affairs
Ultragenyx Pharmaceutical, Inc.

Jeff Broadfoot
Director, Corporate Quality Compliance
Cangene

Alan C. Burns
Vice President, Global Quality
Sartorius-Stedim Biotech.

Claudio Correa Cappai, M.D.
Supply Chain Quality Manager
F. Hoffmann-La Roche, Ltd.

Robert B. Caunce
Quality Manager, Technology Transfer
Hospira

John D. Finkbohner, Ph.D.
Senior Director, Regulatory Affairs
MedImmune

Karen Ginsbury
CEO
PCI Pharmaceutical Consulting Israel Ltd.

Jeffrey L. Hartman
Validation Manager
Merck & Co., Inc.

Barbara Jentges, Ph.D
Managing Director, Regulatory Affairs
PhACT GmbH

Hongyang Li
Vice President, Quality
Novo Nordisk A/S

Edwin Rivera Martinez
Vice President, U.S. Quality Liaison, Global Quality
Sanofi-Pasteur

Lauren Melton
Strategic Regulatory Director
Alnylam

Steven Mendivil
Executive Director, Corporate Quality External Affairs
Amgen, Inc.

Elizabeth Meyers
Senior Manager, International Quality
Amgen

Shin-ichiro Mohri
Director, Sakai Plant
Kyowa Hakko Kirin Co., Ltd.

Dr.-Ing. Stephan Rönninger
Head External Affairs Europe, International Quality
AMGEN (Europe) GmbH

Junko Sasaki
Quality Principal, Investigational Drug Quality
Dainippon Sumitomo Pharma.

Anil D. Sawant, Ph.D.
Vice President, Regulatory Compliance
Johnson & Johnson Consumer Companies

Siegfried Schmitt, Ph.D
Principal Consultant
PAREXEL Consulting

Jacqueline Veivia-Panter
Director, Quality
Abbott Laboratories

PDA TRAINING AND RESEARCH LIAISON - USP PHARMACOPEIA LIAISON

Susan J. Schniepp
Vice President of Quality
Allergy Labs

Jacqueline Veivia-Panter
Director, Quality
Abbott Laboratories

ADVISORY BOARD LIAISONS

Biotechnology Advisory Board (BioAB)
Michael S. VanDerWerf
Associate Director, U.S. Regulatory Affairs, Vaccines
GlaxoSmithKline Biologicals

Scientific Advisory Board (SAB)
Don Elinski
Senior Associate
Lachman Consultants


PDA STAFF LIAISON

Denyse D. Baker
Senior Advisor, Science and Regulatory Affairs
Email: baker@pda.org

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