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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
    Senior Director, Quality Assurance
    Emergent BioSystems
  • Vice-CHAIR
    Jacqueline Veivia-Panter
    GMP/GDP Global Compliance
  • Immediate Past-CHAIR
    Susan J. Schniepp
    Fellow
    Regulatory Compliance Associates, Inc.

Advisory Board Members

  • Karin Baer
    VP Israel & Respiratory Quality Operations
    Teva Pharmaceutical
  • Cylia Chen-Ooi
    Senior Manager, International Quality
    Amgen
  • Veronique Davoust
    Senior Manager, Global Quality Intelligence
    Pfizer
  • Mirko Gabriele
    Global Technology Transfer Sr Manager
    Patheon Italia S.P.A.
  • Dr. Aaron Goerke
    Head of Global Engagement and Deployment
    Roche
  • Tor Graberg
    Head of External Advocacy
    AstraZeneca
  • Dipti Gulati
    Consultant
  • Frithjof Holtz
    Head of Advocacy and Surveillance Life Science | Regulatory Management
    Merck
  • 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.
  • Catriona Murphy
    Consultant Qualified Person
    Eli Lilly and Company
  • Emma Ramnarine
    Director, Head Global Biologics QC
    Genentech
  • Anette Yan Marcussen
    Partner - Compliance and Quality
    NNE
  • Luciana Mansolleli
    Head Strategic Planning Compliance Audit
    Novartis
  • Junko Sasaki
    Sumika Chemical Analysis Service, Ltd
  • Anil D. Sawant, Ph.D.
    VP, Quality Mgmt Sys & External Affairs
    Merck
  • Janeen Skutnik-Wilkinson
    Staff Associate, Compliance & Standards 
    Biogen  
  • Gopi Vudathala
    Exec Director, Quality Advocacy
    GlaxoSmithKline

Advisory Board Liaisons

  • Scientific Advisory Board (SAB)
    Anette Marcussen
    Partner - Compliance and Quality
    NNE

PDA Staff Liaisons

  • Denyse D. Baker
    Director, Science and Regulatory Affairs
    Email: baker@pda.org
  • Dr. Kerstin Wilken
    Director Programs & Education
    Email: wilken@pda.org