July 18, 2012
-- American Conference Institute (ACI) has announced that it will be holding its inaugural Legal, Regulatory and Compliance Forum in New York City at the Carlton Hotel on October 17-19, 2012. This unique program features a distinguished faculty of over two dozen leading legal and regulatory OTC experts - including FDA and USP representatives - who will address the intricacies of the FDA’s proposed new paradigm for ‘OTC drugs with conditions of safe use’ as well as existing challenges affecting such core OTC functions as advertising and promotion; labeling; trademarks, trade names and line extensions; and the modernization of the monograph system.
Also, in light of recent events concerning enforcement actions and recalls in the OTC industry, the conference will feature sessions on effective recall and remediation strategies, cGMPs, esnqv AER review protocols, and FDA, DOJ and FTC enforcement activities.
“The FDA’s proposed new paradigm for a third class of drug coupled with recent enforcement activity will change the OTC arena,” said Lisa J. Piccolo, Senior Industry Manager for Life Sciences and Health care at ACI. "We have designed this conference as a comprehensive forum where the latest legal and regulatory developments affecting non-prescription pharmaceutical products can be discussed. We are also delighted to give our delegates the opportunity to hear directly from the FDA and USP on the proposed new paradigm, potential changes to the OTC Review process, and enforcement.”
More information about this event, including a full agenda, faculty list, and brochure can be accessed at http://www.AmericanConference.com/OTCDrugs