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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
     

    Welcome
    Speaker:
    Barbara Kochanowski, M.S., Ph.D.
    Senior Vice President, Regulatory & Scientific Affairs
    CHPA

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

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

    Product Quality & Manufacturing Committee (PQMC) Chair Report
    Speaker:
    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.

    Moderators:
    Adi Dinge
    Process Development Scientist
    Bayer

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

    Speakers:
    Dave Fillar
    QC Services Associate Director
    Perrigo Company

    Desmond Hunt, Ph.D.
    Principal Scientific Liaison
    USP

    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.

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

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

    Marisa 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
    • Implications of state activities
    • Case study examples of conflicts between federal, state and local government as it pertains to OTC drugs

    Moderator:
    David Campbell
    Head of Regulatory Health, North America
    RB

    Speakers:
    Lawrence P. Halprin, Esq.
    Partner
    Keller and Heckman LLP 

    Paul Kim, Esq.
    Partner
    Foley Hoag

    David Spangler, Esq. 
    Senior Vice President, Policy, and General Counsel
    CHPA

    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.

    Moderator:
    Rose Mary Dollard
    Senior Director, Regulatory Compliance
    Johnson & Johnson

    Speakers:
    Jennifer Ahearn
    Director of Regulatory & Compliance
    Engineering Systems Inc.

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

    Telemedicine: The Implications for Self-Care

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

    Speakers:
    Elyse Altabet
    Marketing Director
    RB

    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.

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

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

    Carlos Gutierrez
    Vice President
    State & Local Government Affairs
    CHPA

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

    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)
    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 OTCs: 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.

    Moderator:
    Catherine Vicente, M.S.
    Enterprise Regulatory Outreach Manager
    Johnson & Johnson

    Speakers:
    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.

    Moderator:
    David Spangler, Esq. 
    Senior Vice President, Policy, and General Counsel
    CHPA

    Speakers:
    Carolyn Herrmann, Esq.
    Deputy General Counsel
    CHPA

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

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

    Communicating in Today’s Media Environment 
    This session will feature a conversation between communication and legal experts on the challenges and benefits of navigating today's media landscape. The speakers will consider the new realities facing the consumer healthcare industry, how to communicate in a crisis and dive into the best practices for communicating scientific and regulatory news to the public. Learn how to leverage your existing understanding of the media environment today, while getting prepared for all the changes ahead. 

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

    Cindy DiBiasi
    Co-Founder
    3D Communications

    Raqiyyah Pippins, Esq.
    Partner
    Arnold & Porter

    9:15 – 9:45 a.m.Refreshment Break
    Closing Session
    9:45 – 10:00 a.m.OTC Monograph Reform Update
    Barbara Kochanowski, M.S., Ph.D.
    Senior Vice President, Regulatory & Scientific Affairs
    CHPA
    10:00 – 10:30 a.m. The Value of OTC Medicines – New Research from CHPA
    Scott Melville
    President & CEO
    CHPA
    10:30 – 11:45 a.m.Closing Panel
    A distinguished panel of leaders from FDA and USP will close out the RSQ conference with an overview of their strategic priorities and an interactive dialogue exploring existing and potential opportunities for collaboration.

    Moderator:
    Peter Kratochvila
    Regional Vice President, Regulatory Affairs: The Americas and Global Lead Switch & Innovation
    GlaxoSmithKline Consumer Healthcare

    Panelists:
    Donald D. Ashley, J.D.
    Director, Office of Compliance
    Center for Drug Evaluation and Research, U.S. FDA

    Theresa M. Michele, M.D.
    Director, Division of Nonprescription Drug Product
    Office of Drug Evaluation IV, Center for Drug Evaluation and Research, U.S. FDA

    Elizabeth Miller, Pharm.D.
    Vice President, U.S. Regulatory Affairs
    U.S. Pharmacopeial Convention

     

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