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  • Schedule

  • Monday, May 20

    5:00 – 6:00 p.m.Early Arrivers Reception

    Tuesday, May 21

    7:00 – 8:30 a.m.Continental Breakfast
    8:30 – 10:00 a.m.Opening Session

    Barbara Kochanowski, M.S., Ph.D.
    Senior Vice President, Regulatory & Scientific Affairs

    Overview of Regulatory, Scientific & Quality Conference (RSQ)
    Peter Kratochvila
    Regional Vice President, Regulatory Affairs: The Americas and Global Lead Switch & Innovation
    GlaxoSmithKline Consumer Healthcare

    Regulatory & Scientific Affairs Committee (RSAC) Chair Report
    Valerie L. Gallagher
    Vice President, Consumer Healthcare Regulatory Affairs
    Perrigo Company

    Product Quality & Manufacturing Committee (PQMC) Chair Report
    Bart D. Shrode
    Vice President, Quality Operations
    Perrigo Company

    Opening Speaker:
    Lauren Silvis
    Chief of Staff
    Food and Drug Administration (FDA) 

    10:00 – 10:30 a.m.Refreshment Break
    10:30 – 11:30 a.m.General Session: The Science Behind Unconscious Bias
     Barbara B. Adams, PsyD
    Founder and Chief Learning Officer
    GAR (Gender, Age, Race) Diversity Consulting
    11:30 a.m. – 1:00 p.m.Luncheon
    1:00 – 2:15 p.m.Quality Session #1Regulatory/Science Session #1Legal Session

    How to Prepare for Changes to USP Packaging Chapters
    This session will outline the proposed changes to the USP Packaging Chapters to include a discussion on the testing requirements that are outlined in the revised chapters. It will also provide insight on the current strategies that should be in place for current approved products as well as products that are under development.

    Adi Dinge
    Process Development Scientist

    Vonnie Lewis
    Director, Regulatory Affairs, Lifecycle, Compliance, CMC and Systems
    Pfizer Consumer Healthcare

    Dave Fillar
    QC Services Associate Director
    Perrigo Company

    Desmond Hunt, Ph.D.
    Principal Scientific Liaison

    Looking Back to Look Ahead: Technology's Role in Self Care
    The Drug Facts Label (DFL) is now 20 years old! Join this session to hear lessons learned since the initial creation of DFL and to explore innovative ways to convey key information about OTC medicines to consumers. This session will also consider the realities faced as consumers turn to online means of communicating about OTCs, learning about treatment for their symptoms, and making their purchase discussions. Speakers will explore the current use of technology in the self-care environment and how emerging technologies, such as artificial intelligence and predictive analytics, influence online purchasing channels. Learn about digital labelling and tools to enhance consumer product information. Leveraging consumer understanding about OTC medicines in a world where digital influences are ubiquitous will be crucial in the future of self-care.

    Liz (Elizabeth) Khalil, B.S., M.S.
    Senior Associate, US Regulatory Affairs
    GSK Consumer Healthcare

    Eric P. Brass M.D., Ph.D. Professor Emeritus of Medicine, David Geffen School of Medicine at UCLA

    Maria Cruz, MD
    Senior Medical Advisor for Digital Health
    Food and Drug Administration (FDA) 

    Jesse Catlin, Ph.D.
    Associate Professor of Marketing College of Business Administration
    California State University, Sacramento

    Guliz Guler
    Associate Director, Regulatory Affairs
    GSK Consumer Healthcare

    Understanding the Relationship between Federal, State, and Local Governments
    In the United States, the three layers of government are at the national, state and local levels. When local governments try to assert control over policy decisions impacting their residents, there can be added complications with state governments. Similarly, states can pass their own laws, as long as they do not contradict with federal law. However, recent trends have shown a shift in the balance of power between states and the federal government. For consumer healthcare companies, understanding the relationship between federal, state and local governance is key to ensuring continued success. Hear from federal and state regulatory and legal experts directly on the following topics:

    • Federalism principles including preemption
    • Schematically, what states frequently do and why
    • Case study examples of conflicts between federal, state and local government as it pertains to OTC drugs

    David Campbell
    Head of Regulatory Health, North America

    Lawrence P. Halprin, Esq.
    Keller and Heckman LLP 

    Paul Kim, Esq.
    Foley Hoag

    David Spangler
    Senior Vice President, Policy, and General Counsel

    2:15 – 2:45 p.m.Refreshment Break
    2:45 – 4:00 p.m.Quality Session #2Regulatory Session #2Regulatory Session #3

    Recent Regulatory Inspection Findings and Trends
    This session will explore the latest inspection findings, trends, and enforcement actions in the OTC drug industry. Hear about top issues, priorities, and goals for 2019 directly from CDER’s Office of Manufacturing Quality and gain practical tips and best practices for responding to enforcement actions and learn how to comply with new and upcoming FDA rules and regulations.

    Rose Mary Dollard
    Senior Director, Regulatory Compliance
    Johnson & Johnson

    Jennifer Ahearn
    Director of Regulatory & Compliance
    Engineering Systems Inc.

    Francis Godwin
    Acting Director, Office of Manufacturing Quality (OMQ)
    Food and Drug Administration (FDA)

    Telemedicine: The Implications for Self-Care

    Greg Smith
    Senior Director, Global Regulatory Lead, Rx-to-OTC Switch

    Elyse Altabet
    Marketing Director

    Brandon Essink, MD, CPI
    Meridian Clinical Research

    Ann Mond Johnson
    Chief Executive Officer
    American Telemedicine Association

    Sunscreens: Interaction of Science and Policy
    In this session, attendees will hear an update from FDA on the proposed rule to finalize the sunscreen monograph. CHPA staff will also provide an overview of the environmental concerns that have led some states to propose to ban sales of certain sunscreen ingredients and legislative activities concerning sunscreens.

    Barbara Kochanowski, M.S., Ph.D.
    Senior Vice President, Regulatory & Scientific Affairs

    Steven Adah
    Lead Chemist
    Division of Nonprescription Drug Products (DNDP)
    Food and Drug Administration (FDA)

    Carlos Gutierrez
    Vice President
    State & Local Government Affairs

    Jay Sirois, Ph.D.
    Senior Director, Regulatory & Scientific Affairs

    4:00 – 4:15 p.m.Break
    4:15 – 5:15 p.m.General Session: Science and the FDA
     Rear Admiral Denise Hinton
    Chief Scientist
    Food and Drug Administration (FDA)
    5:15 – 6:15 p.m.Reception
     Featuring Full Switch
    Scott Abernethy, Frank Becker, Dan Brum – Food and Drug Administration (FDA)
    Saul Gylys – GPSC, LLC
    Greg Smith – Sanofi
    Tim (Major Mit) Greiner - USP

    Wednesday, May 22

    7:00 – 8:00 a.m.Continental Breakfast
    8:00 – 9:15 a.m.Quality Session #3Regulatory Session #4Regulatory Session #5

    Stability Programs for OTC’s: And You Thought This Was Easy?
    This session will give you an insight into some of the unique challenges OTC companies face in establishing the expiration for a product based on accelerated data. Participants in this session will also hear how the stability program requirements were developed and determined for the Neutrogena anti-acne light mask. This session will give participants insight on the unique considerations for OTC’s and innovative approaches for novel medical devices.

    Catherine Vicente
    Enterprise Regulatory Outreach Manager
    Johnson & Johnson

    Lisa Smith
    Principal Scientist, NA Consumer Stability Management
    Johnson & Johnson

    David Wiggins
    Analytical/Stability Consultant

    Cannabis: Separating Fact from Myth
    This session will help you understand the complexities of the science and regulatory considerations for marketing OTC products containing CBD. Hear from experts on the latest happenings in the cannabis industry, including FDA’s evolving policies, recent enforcement activities, and other issues that may help guide your company’s decision making.

    David Spangler
    Senior Vice President, Policy, and General Counsel

    Carolyn Herrmann, Esq.
    Deputy General Counsel

    Douglas "Duffy" MacKay
    Senior Vice President, Scientific and Regulatory Affairs
    CV Sciences

    Jessica P. O’Connell, Esq.
    Covington & Burling LLP

    Communicating in Today’s Media Environment

    Anita Brikman
    Senior Vice President, Communications & Public Affairs, and Executive Director
    CHPA Educational Foundation Communications, CHPA

    Cindy DiBiasi
    3D Communications

    Raqiyyah Pippins, Esq.
    Arnold & Porter

    9:15 – 9:45 a.m.Refreshment Break
    9:45 – 11:45 a.m.Closing Session: OTC Monograph Reform and Closing Panel Discussion


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