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  • Schedule

  • Day 1

     
    10:00 a.m. – 12:00 p.m.Opening General Session

    Welcome
    Speaker:
    Barbara Kochanowski, M.S., Ph.D.
    Senior Vice President, Regulatory & Scientific Affairs
    Consumer Healthcare Products Association

    Overview of Regulatory, Scientific & Quality Conference (RSQ)
    Speaker:
    Greg Smith, M.P.H
    Senior Director, Global Regulatory Lead, Rx-to-OTC Switch
    Sanofi Consumer Healthcare

    Opening Speaker:
    Peter Stein, M.D.
    Director, Office of New Drugs
    Center for Drug Evaluation and Research (CDER)
    U.S. Food and Drug Administration (FDA)

    Science Miscommunication
    Speaker: Timothy Caulfield, LL.M.
    University of Alberta (Canada)

    Timothy Caulfield is a Canada Research Chair in Health Law and Policy, a Professor in the Faculty of Law and the School of Public Health, and Research Director of the Health Law Institute at the University of Alberta. His interdisciplinary research on topics like stem cells, genetics, research ethics, the public representations of science and health policy issues has allowed him to publish over 350 academic articles. He has won numerous academic and writing awards and is a Fellow of the Royal Society of Canada and the Canadian Academy of Health Sciences. He contributes frequently to the popular press and is the author of two national bestsellers: The Cure for Everything: Untangling the Twisted Messages about Health, Fitness and Happiness (Penguin 2012) and Is Gwyneth Paltrow Wrong About Everything?: When Celebrity Culture and Science Clash (Penguin 2015). His most recent book is The Vaccination Picture (Penguin, 2017). Caulfield is also the host and co-producer of the award-winning documentary TV show, A User’s Guide to Cheating Death, which has been shown in over 60 countries and is currently streaming on Netflix.
    9:00 a.m. – 5:00 p.m.Virtual Sponsor Area Hours
    2:00 p.m. – 3:00 p.m.

       

    Track 1 

     
    Customer Complaints: Best Practices from Case Studies

    This session provides a forum for discussions centered on consumer complaints and offers an opportunity to hear about the case studies and requirements that help assure the availability of high-quality OTC products to the consumer. Attendees will hear directly from industry leaders about how to meet the challenges of responding to consumer complaints and the learnings to improve quality systems.

    Moderator and Speaker:
    Nelson Webb
    QA- Data Integrity Leader
    The Procter & Gamble Company

    Speakers:
    John Lovro
    Senior Director, Quality
    Combe Incorporated

    Stacey Platzer
    Senior Director, Quality Technical Support and Central Labs
    Bausch Health Companies
    2:00 p.m. – 3:00 p.m.

    Track 2 

     
    Curent Topics in Sustainability

    This session provides a forum for discussions centered on sustanability and offers an opportunity to hear about the latest issues in the science communication of emerging issues, microplastics and innovative packaging solutions. Attendees will hear from researchers and industry about how to meet the challenges of communicating, studying and manufacturing for the current landscape. Colgate Palmolive Company will share the development of their new fully-recyclable toothpaste tube. The tube, which was made public in June, and is set to go into stores in the U.S., took five years to develop. Colgate is now adapting its factories to manufacture the tube to meet its goal of selling only recyclable, reusable or compostable packaging by 2025. 

    Moderator: 
    Aditya Dinge, Ph.D.
    Process Development Scientist
    Bayer Healthcare LLC

    Speakers:
    Jennifer Boada Rodriguez
    Senior Technical Associate Global Packaging, Oral Care
    Colgate-Palmolive Company

    Brianne Della Savia, Doctoral Student
    Institute for Resources, Environment and Sustainability
    The University of British Columbia
    2:00 p.m. – 3:00 p.m.
     

    Track 3 

    A Regulatory Perspective on Consumer Preferences and Perceptions

    The consumer desire for natural, free-of, organic and botanical ingredients and products is growing. Panelists will highlight real-life examples to address current and future regulatory expectations of these consumers. During this session, participants will be provided with an overview of the Botanical Safety Consortium and will learn more about ways to maneuver through definitions and successfully meet regulatory requirements and launch innovative products. Attendees will also hear from the FDA CFSAN Office of Cosmetics and Colors about its role in regulating consumer products including OTC/cosmetic drugs. Learn how CFSAN certifies colors used in these consumer products and its interaction with other FDA Centers and governmental agencies to provide regulatory oversight.

    Moderator
    Angela Clarke-Sheehan
    Section Head, Personal Health Care US Regulatory
    The Procter & Gamble Company

    Speakers:
    Linda M. Katz, M.D., M.P.H. (invited)
    Director, Office of Cosmetics and Colors
    Center for Food Safety & Applied Nutrition (CFSAN)
    U.S. Food and Drug Administration (FDA)

    Daniel S. Marsman, Ph.D.
    Head, Personal Health Care Safety
    The Procter & Gamble Company

    Jessica O'Connell, J.D.
    Partner
    Covington & Burling
    3:00 p.m. – 4:00 p.m.     Small Group Networking
    5:00 p.m. – 6:00 p.m.  Networking - "Full Switch" Band Opening

    Day 1-3

     
    Available on DemandRegulatory & 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:
    Catherine Vicente
    Manager, ERO-Enterprise Regulatory Outreach
    Johnson & Johnson Consumer, Inc.

    Consumer Medical Devices Committee (CMD Committee) Chair Report
    Speaker:
    Kathleen Blieszner, Ph.D.,
    Global Product Stewardship, Regulatory Affairs, FemCare
    The Procter & Gamble Company

    CDRH’s Deputy Center Director Medical Device Policy Update
    Ellen Flannery, J.D.
    Deputy Center Director for Policy
    Center for Devices and Radiological Health (CDRH)
    U.S. Food and Drug Administration

    Dietary Supplement Committee (DSC) Chair Report
    Speaker:
    Kathy Kramp
    Senior Scientist - Regulatory Affairs
    Procter & Gamble

    Hot Topics and Trends in Nutrition and Dietary Supplements

    Join leading experts from industry, academia and NGOs who will discuss ongoing and emerging regulatory, scientific, legislative and business development topics of importance to the dietary supplements and nutrition industry and stakeholders. Our speakers will examine a number of different topics including:

    • Dietary Supplement Use in the United States 
      Speaker:
      Jaime Gahche, Ph.D., MPH, Nutritional Epidemiologist, National Institutes of Health Office of Dietary Supplements 
    • Regulatory update on Natural Health Products in Canada 
      Speaker:
      Kristin Willemsen, Director, Scientific & Regulatory Affairs, Consumer Health Products Canada
    • Cannabis Inflorescence for Medical Purposes: USP Considerations for Quality Attributes 
      Speaker:
      Nandakumara Sarma, Ph.D., Director, Dietary Supplements and Herbal Medicines, United State Pharmacopeia
    • Advancing the Quality of Dietary Supplements 
      Speakers:
      Joe Nadglowski, President and CEO, Obesity Action Coalition
      Christine Burdick-Bell, Executive Vice President, General Counsel & Corporate Secretary, Pharmavite, LLC
    • Overview of the NDI and GRAS Processes for the Supplement Industry 
      Speaker:
      Diane McEnroe, Partner, Sidley Austin LLP
    • Role of Anthocyanins in Oxidative Stress and Cancer in the Digestive System
      Speaker:
      Elvira de Mejia, Ph. D., Professor and Director, Division of Nutritional Sciences, University Scholar, Department of Food Science and Human Nutrition University of Illinois
    • The Need for Dietary Recommendations for Bioactive Food Components
      Speaker:
      John W. Erdman, Ph.D., Professor Emeritus, Nutritional Sciences, University of Illinois

    Endocannabinoid System: Product Profiles and Outcomes We need to Know
    Speaker:
    Slavko Komarnytsky, Ph.D. Associate Professor
    NC State University. Head of Phytonutrient Research Lab
    Plants for Human Health Institute.

    HEMP/CBD Oils – Product Profiling and Market Launch Requirements
    Speaker:
    Carl Germano, CNS, CDS, Vice President and Chief Science Officer
    Verdant Oasis

    Panel Discussion - The Dietary Supplements Category: The Next Generation

    A panel discussion on the future of the category with expert panelists from key disciplines. Each expert will help build a 360 degree view and provide insight on how the category can continue to grow and impact consumer health practices supported by a strengthened regulatory framework . Expert panelists will provide unique perspectives on the state of the supplement industry including:

    DSHEA: The First 25 Years, Now What?
    Speaker:
    Scott Bass
    Partner and Life Sciences Lead
    Sidley Austin

    Regulatory Oversight: How the Process Works
    Speaker:
    Steven Tave, J.D.
    Director
    Office of Dietary Supplements
    U.S. Food and Drug Administration

    Business Expectations: New Opportunities & Responsibilities
    Speaker:
    Greg Horn
    President and CEO , Specialty Nutrition Consulting, Inc and Managing Director and Senior Advisor, William Hood and Company

    The Clinical Perspective: What We Need to Know
    Speaker:
    Pieter Cohen, MD
    Harvard Medical School, Assistant Professor of Medicine,
    Harvard Medical School and General Internist, Cambridge Health Alliance

    The Media: Information that Affects the Dietary Supplements Category
    Speaker:
    Hank Schultz
    Deputy Editor
    Nutra Ingredients USA

    Enabling Brand Positioning
    Speaker:
    Kyle Garner
    Chief Executive Officer
    Maty’s Health Products (Division of Bayer Consumer Health Care)
    Bayer Consumer Health Care

    Empowered Consumer Practices in Health Management
    Speaker:
    Marsha McGraw
    Senior Vice President, US Sales, Catalina USA
    Catalina


     

    Day 2

     
    8:00 a.m. – 5:00 p.m.Virtual Sponsor Area Hours
    10:00 a.m. – 11:30 a.m.

    Track 1 

     

    Creating Value Through Quality Metrics

    Join this session to learn through an interactive forum for learning and discussion centered on quality metrics. You will hear first-hand from FDA and industry leaders, through case studies on leveraging quality metrics as a tool for business growth in addition to meeting GMP compliance requirements along with a question and answer period.

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

    Speakers:
    Lucinda Buhse, Ph.D.
    Director, Office of Quality Surveillance
    Center for Drug Evaluation and Research
    U.S. Food and Drug Administration (FDA)

    Steve Greer
    Corporate Quality Assurance External Engagement Leader
    The Procter & Gamble Company
    10:00 a.m. – 11:30 a.m.

    Track 2

    Alternatives to Animal Testing

    The product safety evaluation process is often divided into at least two sections: preclinical safety studies which were traditionally performed with animals, and clinical safety to evaluate the product under use conditions in humans. The scientific and regulatory communities face growing pressure to move away from using traditional animal toxicity studies to address the preclinical safety endpoints. Numerous ethical, scientific, business, and legislative incentives and consumer demands continue to drive this shift. Protocols for assessing topical toxicity, sensitization potential, skin penetration, phototoxicity, and genetic toxicity are now the subject of OECD Test Guidelines to promote international mutual acceptable of data. This session provides a forum for discussions centered on progress towards animal alternative methods for toxicity testing of chemicals and mixtures.

    Moderator:
    Jennifer Palmer
    Associate Director, Quality Assurance/RSO
    Sanofi Consumer Healthcare

    Speakers:
    John Harbell, Ph.D.
    Independent Consultant
    EAS Consulting Group, LLC

    Amy Roe, Ph.D.,DABT
    Principal Toxicologist, Product Safety & Regulatory Affairs
    The Procter & Gamble Company


    10:00 a.m. – 11:30 a.m.

    Track 3 

    Staying Smart in a Smart World

    With the evolution of artificial intelligence and devices everything is getting smarter. Nearly everyone knows that following FDA regulations and guidance is critical but what about the other key regulator - the Federal Trade Commission (FTC) - that plays a key role in oversight for this emerging and evolving category? In this session attendees will hear about research, regulatory, and legal insights on how to effectively manage the benefits and risks of emerging digital technologies in this increasingly smart world while modernizing substantiation development and consumer engagement strategies related to consumer health. Additionally, two speakers from the Better Business Bureau (BBB) and a DC-based law firm will bring their legal expertise and experience to the conversation.

    Moderator:
    Raqiyyah Pippins, J.D.
    Partner
    Arnold & Porter Kaye Scholer LLP

    Mary K. Engle, J.D.
    Executive Vice President, Policy
    BBB National Programs, Inc.

    Richard Cleland, J.D.
    Assistant Director, Advertising Practices
    U.S. Federal Trade Commission (FTC)
    2:00 p.m. - 3:30 p.m.

    Track 1

    COVID-19 Impact on OTC Industry – Live Discussion Forum

    The purpose of this Interactive Session is to SHARE & DISCUSS professional experiences and Lessons Learned while we are navigating through the new world as a result of the COVID-19 pandemic. How have you and your staff been impacted by regulations, flexible guidance, and/or remote audits? How did you mitigate the impact on your manufacturing or stability programs? How are you managing remote work environments? What does the New Normal look like for your company? Continued remote working, social distancing, relying on technology, new ways of connecting with your teams?

    Facilitators:
    Jing Capucao, Ph.D.
    Stability Manager
    Johnson & Johnson Consumer Inc. 

    Catherine Vicente
    Manager, ERO-Enterprise Regulatory Outreach
    Johnson & Johnson Consumer, Inc.

    2:00 p.m. - 3:30 p.m.

    Track 2 

    OTC Technology and Emerging Policies (CMD Advances)

    This session is designed help inform the development of a more streamlined regulatory approach to provide oversight of software-based medical devices and the role technology can play in selfcare. Hear from the Agency’s Center of Devices and Radiological Health (CDRH) about its Fall 2019 Guidance on Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act. This guidance addresses general wellness products verses OTC medical devices. Additionally, FDA will provide an overview of key elements of the FDA Precertification (Pre-Cert) Pilot program. Attendees will also hear from the Heart Rhythm Society about its joint publication with the Consumer Technology Association (CTA) (released in January 2020) which gives advice to consumers about wearable health solutions. RSQ participants will also learn about Johnson & Johnson’s first-in-kind virtual research program designed to study if using an iPhone application and an Apple Watch can reduce the risk of stroke. If your organization is interested in consumer medical devices or digital technology, you won’t want to miss this session.

    Moderator:
    Verna Macedon
    Regulatory Affairs
    Bayer Consumer Health

    Sonja B. Fulmer, Ph.D.
    Assistant Director for Digital Health Policy
    Center for Devices and Radiological Health (CDRH)
    U.S. Food and Drug Administration

    John Whang, M.D.
    Sr Director, Integrated Evidence Team
    Janssen Pharmaceuticals

    Christina J. Wurster, M.B.A.
    Chief Strategy Officer
    Heart Rhythm Society
     
    2:00 p.m. - 3:30 p.m.

    Track 3 

    Enabling Consumer Decision Making in the Self-Care Environment

    Research has repeatedly demonstrated that consumers have difficulties understanding the essential information from the drug facts label and principle display panel to select and use their OTC products. The general lack of knowledge and understanding has been frequently cited as a leading root cause of the many cases of unintentional misuse/abuse of OTC products that have translated to ‘therapeutic misadventures. This session will describe the role of behavioral sciences in informing more effective product communication to consumers through a discussion of concepts related to decision-making and health literacy to ensure the information provided is understandable, actionable and motivational.

    Panelists:
    Julie Aker (ASCP)
    President & Chief Executive Officer
    Concentrics Research LLC

    Laura Bix, Ph.D.
    Professor, School of Packaging
    Michigan State University

    Michael S. Wolf, M.A., M.P.H, Ph.D.
    Associate Vice Chair for Research, Department of Medicine
    Director, Institute for Public Health and Medicine (IPHAM) - Center for Applied Health Research on Aging

    James R. Webster, Jr., Professor of Medicine
    Northwestern University Feinberg School of Medicine

    Amanda H. Pike-McCrudden
    Social Science Analyst
    Division of Nonprescription Drug Products I
    Office of Drug Evaluation IV/Office of Nonprescription Drug Products
    Center for Drug Evaluation and Research
    U.S. Food and Drug Administration
    4:00 p.m. - 5:00 p.m. Small Group Networking

    Day 3

     
    9:00 a.m. – 2:00 p.m.Virtual Sponsor Area Hours
    10:00 a.m. – 11:00 a.m.Rosemary Gibson
    Author of China Rx: Exposing the Risks of America’s Dependence on China for Medicine

    The presentation will highlight increasing U.S. dependence on China for medicinal products and the key ingredients to make generic drugs such as antibiotics and over-the-counter products. The implications of the growing concentration of medicine-making in a single country and the challenges it poses to quality and health security will also be discussed.
    11:00 a.m. – 12:00 p.m.FDA/USP Leadership Panel Discussion

    Moderator:
    Barbara Kochanowski, M.S., Ph.D.
    Senior Vice President, Regulatory & Scientific Affairs
    Consumer Healthcare Products Association (CHPA)

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

    Theresa M. Michele, M.D.
    Director, Office of Nonprescription Drug Products
    Office of Drug Evaluation IV, Center for Drug Evaluation and Research
    U.S. Food and Drug Administration (FDA)

    Ronald T. Piervincenzi, Ph.D.,
    Chief Executive Officer
    United States Pharmacopeia (USP)
    12:00 p.m. – 1:00 p.m.OTC Monograph Reform and Hot Topics

    Moderator:
    Greg Smith, M.P.H.
    Senior Director, Global Regulatory Lead, Rx-to-OTC Switch
    Sanofi Consumer Healthcare

    Panelists:
    Barbara Kochanowski, M.S., Ph.D.
    Senior Vice President, Regulatory & Scientific Affairs
    Consumer Healthcare Products Association (CHPA)

    Theresa M. Michele, M.D.
    Director, Office of Nonprescription Drug Products
    Office of Drug Evaluation IV, Center for Drug Evaluation and Research
    U.S. Food and Drug Administration (FDA)

    Karen M. Mahoney. M.D.
    Deputy Director, Office of Nonprescription Drug Products
    Acting Director, Division of Nonprescription Drug Products I
    Office of Nonprescription Drugs (ONPD)
    U.S. Food and Drug Administration (FDA)

    Francis Becker, M.D.
    Acting Director, Division of Nonprescription Drug Products II
    Office of Nonprescription Drugs (ONPD)
    Office of Drug Evaluation IV, Center for Drug Evaluation and Research
    U.S. Food and Drug Administration (FDA)

     

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