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)
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)
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)
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
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)