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  • 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., Vice President, Regulatory & Scientific Affairs, Consumer Healthcare Products Association

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

    • 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, Regulatory Affairs, 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, 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, Ph.D., The Medical Futurist
    11:30 – 1:00 p.m.Joint Luncheon
    1:00 – 2:00 p.m.Joint Session
     
    • Science, Policy & Politics
      Susan WoodSpeaker: 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
     OTC Monograph Reform

    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: 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; other speakers TBA; Steven A. Greer, Corporate Quality Assurance External Engagement Leader, The Procter & Gamble Company, (Moderator)
    Session level (intermediate-expert)

    OTC Advertising Compliance: Past, Present & Future

    Speakers: Richard Cleland, Assistant Director, Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission; and Kathleen Dunnigan, Senior Staff Attorney, National Advertising Division, Council of Better Business Bureaus; TBA (Moderator)

    3:15 – 3:45 p.m.Joint Refreshment Break
    3:45 – 5:00 p.m.Regulatory/Scientific Track Product Quality Track Legal Track
     Regulatory/Scientific Session 2

    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, Director, Excipients, U.S. Pharmacopeial Convention; Steven Wolfgang, 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)
    Session level (beginner-intermediate)

    Using Technology to Increase Use of Consumer Healthcare Products without Increasing Legal Risk

    Speakers: Raqiyyah R. Pippins, Esq., Counsel, Arnold & Porter LLP; Mark Brian Levine, Associate General Counsel, RB; additional speaker TBA; and Renuka D. Singh, Senior Regulatory Counsel, RB (Moderator)

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

    Friday, May 12

    7:00 a.m. – 3:30 p.m.Registration
    7:00 – 8:00 a.m.Continental Breakfast
    8:00 – 9:15 a.m.Regulatory/Scientific Track Product 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 Analyst, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (Moderator)

    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: Alberto Cuitino, Ph.D., Department Chair and Professor, Mechanical & Aerospace Engineering, Rutgers University; Ding Ming, Ph.D., Vice President, Research & Innovation, U.S. Pharmacopeial Convention; additional speakers TBA
    Session 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
    • 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

     

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