Meeting Graphic Banner

  • Schedule

  • Thursday, May 11

    7:00 a.m. – 3:30 p.m.Registration
    7:00 – 8:00 a.m.Continental Breakfast
    8:00 – 10:00 a.m.Joint Opening Session
     
    • Welcome
      Speaker: Barbara A. Kochanowski, Ph.D., Senior Vice President, Regulatory & Scientific Affairs, Consumer Healthcare Products Association

    • Overview of Regulatory, Scientific & Quality Conference (RSQ)
      Speaker: David W. Grob, Vice President, Regulatory Affairs, Sanofi CHC/Chattem

    • Regulatory & Scientific Affairs Committee (RSAC) Chair Report
      Speaker: Greg Collier, Ph.D., Global Director, Healthcare Safety, Regulatory, and Analytical, The Procter & Gamble Company

    • Product Quality & Manufacturing Committee (PQMC) Chair Report
      Speaker: Ajay Chawla, Regional Audits Compliance Manager, RB

    • FDA Update with Dr. Janet Woodcock
      Join this session to hear Center Director Dr. Janet Woodcock’s insights and observations on the state of regulatory, scientific, and quality issues affecting OTC medicines. Additionally, she will share her perspective on OTC Monograph reform.
      Janet WoodcockSpeaker: Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, U.S. Food & Drug Administration
    • The Critical Value of Quality
      Dinesh Thakur shook up the pharma industry when he blew the whistle on quality issues at Ranbaxy Laboratories resulting in $500 million in fines and penalties against the company. Join this session to hear from Thakur about the importance of creating a culture of quality within your organization that focuses on medicine quality and supply chain integrity. Also, learn about the impact of poor quality medicines on public health and the importance of regulatory reform.
      Dinesh ThakurSpeaker: Dinesh Thakur, Public Health Activist and Chairman, Medassure Global Compliance Corporation
    10:00 – 10:30 a.m.Joint Refreshment Break
    10:30 – 11:30 a.m.Joint Session
     
    • Technology’s Impact on Advancing Consumer Self-Care
      As science and technology advance, the pharmaceutical industry is facing huge challenges and opportunities. Join this session to hear how disruptive technologies like 3D printed drugs, artificial intelligence guided therapies, and preventive medicine can help advance drug development and treatment. Learn what the future of medicine looks like and how the OTC medicine industry may be affected.
      Bertalan MeskoSpeaker: Bertalan Mesko, M.D., Ph.D., The Medical Futurist
    11:30 – 1:00 p.m.Joint Luncheon
    1:00 – 2:00 p.m.Joint Session
     
    • Science, Policy & Politics
      This session will focus on the impact of science, policy and politics on product approval and use, specifically oral contraceptives and naloxone. Speakers will focus on the feasibility of expanded access to these products and discuss other potential product categories for OTC access.
      Erin HassSusan WoodSpeakers (l-r): Erin Haas, Local Programs Manager, Overdose Prevention, Maryland Department of Health and Mental Hygiene; Susan F. Wood, Ph.D., Associate Professor of Health Policy and Management, George Washington University Milken Institute School of Public Health; and Director of the Jacobs Institute of Women’s Health Service
    2:00 – 3:15 p.m.Regulatory/Scientific TrackProduct Quality TrackLegal Track
     

    Update on OTC Monograph Reform
    What started as a concept is close to becoming reality! Hear about the progress industry and FDA have made to enact important regulatory reforms to the OTC Monograph System. During this session, attendees will learn about the benefits of reform, key reform concepts, and an update on translating policy into legislation.

    Speakers: Barbara A. Kochanowski, Ph.D., Senior Vice President, Regulatory & Scientific Affairs, Consumer Healthcare Products Association; David Spangler, Senior Vice President, Policy, and General Counsel & Secretary, Consumer Healthcare Products Association

    Panelists: Greg Collier, Ph.D., Global Director, Healthcare Safety, Regulatory, and Analytical, The Procter & Gamble Company; Theresa M. Michele, M.D., Director, Division of Nonprescription Drug Products, Office of Drug Evaluation IV, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

    Attendee level: Intermediate

    Quality Metrics Programs
    This session explores some benefits and challenges for implementing quality metrics programs. Speakers will focus on the specific challenges posed by the new reissued guidance for the OTC pharmaceutical industry and will propose solutions to these challenges.

    Speakers: Betsy Fritschel, Director, Johnson & Johnson Consumer, Inc., Steven A. Greer, Corporate Quality Assurance External Engagement Leader, The Procter & Gamble Company, (Moderator)

    Panelist: Tara Gooen Bizjak, Senior Science Policy Advisor for Pharmaceutical Quality, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

    Attendee level: Intermediate, Expert

    OTC Advertising Compliance: Past, Present & Future
    Hear from experts at the Federal Trade Commission and the National Advertising Division at the Council of Better Business Bureaus on OTC drug advertising compliance trends, including past and present cases and areas to watch out for in the future to avoid sanctions.

    Speakers: Richard Cleland, J.D., Assistant Director, Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission; and Kathleen Dunnigan, J.D., Senior Staff Attorney, National Advertising Division, Council of Better Business Bureaus; Todd H. Halpern, J.D., Assistant General Counsel, Regulatory Law, Pfizer Consumer Healthcare (Moderator)

    Attendee level: Intermediate

    3:15 – 3:45 p.m.Joint Refreshment Break
    3:45 – 5:00 p.m.Regulatory/Scientific Track Product Quality Track Legal Track
     

    Rx-to-OTC Switch: Translating Technology-Based Innovations into Product Approval and Competitive Differentiation
    Advances in app-enabled self-care and at-home diagnostics are creating new opportunities for Rx-to-OTC switches. Making successful switches that incorporate technology requires a science-based approach that applies innovations to key switch challenges, including self-selection and actual use in the real world. During this session, hear about specific examples of how technology-based innovations are being used by sponsors to facilitate product approval and create competitive differentiation for their products in the OTC marketplace, and what the future may hold.

    Speakers: Michael Benecky, Ph.D., Sr Dir, Regulatory Affairs, GSK Consumer Healthcare; Saul Shiffman, Ph.D., Senior Scientific Advisor, Behavioral Science, Study Design, and Analysis, Pinney Associates, Inc.; Michael Hufford, Ph.D., Vice President, Regulatory Affairs, Behavioral Science & Innovation, Pinney Associates, Inc. (Moderator)

    Attendee level: Beginner, Intermediate

    Atypical Actives/Inert Ingredients: Exploring the Current Situation
    This session explores the challenges for the unique regulatory and compendial issues of Atypical Actives. Many OTC drugs depend on Atypical Actives which may not have any suppliers of material made to ICH Q7 API GMPs. Speakers will focus on regulatory and compendial approaches that could be developed with the assistance of the newly created industry coalition.

    Speakers: Catherine Sheehan, Senior Director, Excipients, U.S. Pharmacopeial Convention; Steven Wolfgang, Ph.D., Acting Associate Director, Office of Drug Security, Integrity and Recalls, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Priscilla Zawislak, Chair, IPEC Americas (Moderator)

    Attendee level: Beginner, Intermediate

    Consumer Healthcare Initiatives in the Digital World
    Consumer healthcare product companies must balance integrating digital and social media into their promotional strategies for their products, without bringing undue legal and regulatory risk to their companies. This session will include both in-house and outside counsel perspectives on the current legal and regulatory landscape in this space. Attendees will hear about important legal and regulatory considerations that consumer healthcare product companies should keep in mind, including avoiding unwanted FDA regulatory classifications, managing data privacy and security obligations, reducing the risk of class action litigation, and mitigating exposure for expanded adverse event reporting obligations.

    Speakers: Mark Brian Levine, Esq., Associate General Counsel, RB; Raqiyyah R. Pippins, Esq., Counsel, Arnold & Porter Kaye Scholer LLP; Cara Taylor, Esq., Consumer Healthcare Industry Lead, Clarkston Consulting Group, Inc.; Renuka D. Singh, Senior Regulatory Counsel, RB (Moderator)

    Attendee level: Intermediate

    5:00 – 6:00 p.m.Joint Networking Reception

    Friday, May 12

    7:00 – 10:00 a.m.Registration
    7:00 – 8:00 a.m.Continental Breakfast
    8:00 – 9:15 a.m.
    Regulatory/Scientific TrackProduct Quality Track
     

    Considerations for Human Factors Validation Studies for OTC products
    Traditionally, consumer behavior studies for OTC products have included label comprehension, self-selection, and actual use. When developing an OTC combination product, human factors considerations and evaluations should be incorporated in the research and development programs. Join this session to hear from FDA and industry on the criteria for determining the appropriate application of human factors studies and the elements of human factors validation study design.

    Speakers: QuynhNhu Nguyen, Associate Director for Human Factors, Division of Medication Errors and Prevention Analysis, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Adam R. Shames, Founder and CEO, Core Human Factors, Inc.; and Barbara Cohen, Social Science Reviewer, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (Moderator)

    Panelist: Danielle Harris, Acting Deputy Director, Division of Medication Error Prevention and Analysis, Center Research, U.S. Food and Drug Administration

    Attendee level: Beginner, Intermediate

    Current Issues in Manufacturing: Opportunities & Challenges
    This session explores the unique technical issues of continuous manufacturing. Speakers will introduce this transformative production process and discuss aspects of integration of analytical tools, data management, sampling, enhanced process understanding, and implementation of multivariate analysis for determination of product quality.

    Speakers: Celia Cruz, Ph.D., Director, Division of Product Quality Research, U.S. Food and Drug Administration; Alberto Cuitino, Ph.D., Department Chair and Professor, Mechanical & Aerospace Engineering, Rutgers University; Robert Femia, Ph.D., Senior Vice President of Chemical Medicines and General Chapters, U.S. Pharmacopeial Convention; James Murphy, Executive Director - Regulatory CMC, Pfizer Consumer Healthcare (Moderator)

    Attendee level: Beginner, Intermediate

    9:15 – 9:45 a.m.Joint Refreshment Break
    9:45 – 11:45 a.m.Joint Closing Session
     
    • Update from the U.S. Centers for Disease Control and Prevention
      Join this session to hear Dr. Daniel Budnitz, director of the U.S. Center for Disease Control and Prevention (CDC) Medication Safety Program, give an update on the PROTECT (Protecting Overdoses and Treatment Errors in Children Taskforce) Initiative. Budnitz will also discuss the completion of the standard method for evaluating flow restrictors, and he will highlight potential product categories for broader use of unit dose packaging. Attendees will also hear about recent trends the CDC is observing on medication use in older children.
      Dan BudnitzSpeaker: Daniel S. Budnitz, M.D., Director, Medication Safety Program, Division of Healthcare Quality Promotion, U.S. Centers for Disease Control and Prevention
    • Update on CHPA Educational Foundation Programs
      Hear about new initiatives from CHPA’s Educational Foundation, the trusted source of information on how to safely use, store, and dispose of OTC medicines and dietary supplements.
      Anita BrikmanSpeaker: Anita Brikman, Senior Vice President, Communications & Public Affairs, and Executive Director, CHPA Educational Foundation
    • FDA Closing Panel
      Get an insider’s view from FDA on their achievements, future initiatives and issues affecting the OTC medicine industry
      Michael KopchaTheresa MicheleBrad Pace
      Speakers (l-r): Michael Kopcha, Ph.D., Director, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Theresa M. Michele, M.D., Director, Division of Nonprescription Drug Products, Office of Drug Evaluation IV, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; John Pace (Brad), J.D., Director, Division of Nonprescription Drugs and Health Fraud, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; additional speaker TBA

     

© 2017 Consumer Healthcare Products Association. All Rights Reserved.