The Future of OTC Drug Regulation and the Monograph Process 2015

Key Topics

• Distinguish between a potential Rx pharmaceutical product and an OTC drug
• A comprehensive understanding of how OTC drug products are regulated in the U.S
• How to identify and successfully navigate an OTC drug monograph
• The difference between the various pathways for commercializing an OTC drug product
• An update on FDAs March 25-26, 2014 public hearing that was organized to obtain industry input on methods for the ways that OTC drugs are regulated in the U.S. today
• When reliance on a proposed rule, final rule and/or drug monograph is appropriate
• The required elements of a compliant OTC drug label
• How FDA proposes to enhance the OTC Monograph Process
• The use of the Time and Extent Application (TEA) process, and learn about FDAs proposal to update the process allow for the acceptance of foreign data where OTC drug ingredients have been safely marketed outside the United States over a prolonged period
• Strategies for marketing and promoting OTC drug products, and for mitigating potential enforcement risks
• Several of FDAs current OTC monographs
• A working knowledge of the Rx-to-OTC switch process

Who should Attend

• Regulatory and compliance professionals
• Quality professionals
• Manufacturing engineers
• Production supervisors and engineers
• Labelers and private labelers
• Design engineers
• Importers and custom agents
• Contract manufacturers
• Process owners
• U.S. agents of foreign corporations
• Record retention specialists
• Document control specialists
• Legal professionals
• Medical affairs
• Consultants, inspectors and cGMP experts
• Financial advisors and institutional investors