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)
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)
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 TBASession level (beginner-intermediate)