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Parenteral Drug Association Connecting People, Science and Regulation ®

Regulatory and 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 to 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 the current chair or Denyse Baker (baker@pda.org).

Regulatory Affairs and Quality Advisory Board Members

  • CHAIR
    Jeff Broadfoot
    Director, Corporate Quality Compliance 
    Emergent BioSystems
  • Vice-CHAIR
    Jacqueline Veivia-Panter
    Consultant
  • Immediate Past-CHAIR
    Ms. Susan J. Schniepp
    Sr. Consultant
    Regulatory Compliance Associates, Inc.

Advisory Board Members

  • Ruhi Ahmed, Ph.D., RAC
    Senior Director, Regulatory Affairs
    Ultragenyx Pharmaceutical, Inc.
  • Karin Baer
    VP Israel & Respiratory Quality Operations
    Teva Pharmaceutical
  • Cylia Chen-Ooi
    Senior Manager, International Quality
    Amgen
  • Veronique Davoust
    Senior Manager, Global Quality Strategy
    Pfizer
  • Mirko Gabriele
    Tech Transfer Manager
    Patheon Italia S.P.A.
  • Tor Graberg
    Head of External Advocacy
    AstraZeneca
  • Dipti Gulati
    Consultant
  • Frithjof Holtz
    Head of Advocacy and Surveillance Life Science | Regulatory Management
  • Karen Ginsbury
    CEO
    Pharmaceutical Consulting Israel, Ltd.
  • Jeffrey L. Hartman
    Senior Consultant
    Concordia Valsource
  • Hongyang Li
    Vice President, Quality
    Novartis
  • Steve Lynn
    VP, Global Head, Group Compliance and Audit
    Novartis
  • Demetra Macheras
    Director, Regulatory Policy and Intelligence
    AbbVie, Inc.
  • Elizabeth Meyers
    Senior Manager, International Quality
    Amgen
  • Shin-ichiro Mohri
    Director, Sakai Plant
    Kyowa Hakko Kirin Co., Ltd.
  • David Perkins
    Director, Quality and Compliance
    Abbvie, Inc.
  • Emma Ramnarine
    Head of Global Biologics
    Genentech
  • Anette Yan Marcussen
    Director, Quality Intelligence
    Novo Nordisk
  • Luciana Mansolleli
    Group Compliance and Audit Operations
    Novartis
  • Edwin Rivera Martinez
    Vice President, U.S. Quality Liaison, Global Quality
    Sanofi-Pasteur
  • Junko Sasaki
    Quality Principal, Investigational Drug Quality
    Dainippon Sumitomo Pharma.
  • Anil D. Sawant, Ph.D.
    Vice President, Regulatory Compliance
    Johnson & Johnson Consumer Companies
  • Janeen Skutnik-Wilkinson
    Staff Associate, Compliance & Standards 
    Biogen  
  • Jacqueline Veivia-Panter
    Consultant

Advisory Board Liaisons

  • Biotechnology Advisory Board (BioAB)
    Wendy Z. Lambert
    CMQ/OE, RAC Divisional Validation Lead
    Novartis Pharma AG
  • Scientific Advisory Board (SAB)
    Jeff Hartman
    Senior Consultant
    Concordia Valsource

PDA Staff Liaison

  • Denyse D. Baker
    Director, Science and Regulatory Affairs
    Email: baker@pda.org
  • Morgan Holland
    Coordinator, Science and Regulatory Affairs
    Email: holland@pda.org
  • Georg Roessling, PhD
    Senior Vice President, PDA Europe
    Email: roessling@pda.org