Legal, Regulatory and Compliance Forum on
Over the Counter Drugs
A comprehensive guide to the latest developments affecting non-prescription drug products
Tuesday, October 29 to Wednesday, October 30, 2013
The Carlton on Madison, New York, NY
Prepare to meet the challenges of the rapidly evolving legal and regulatory landscape of the non-prescription drug industry.A distinguished faculty will address the intricacies of this new proposal 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. They will provide you with the critical information that you need to:
FDA's proposed introduction of a new paradigm for 'OTC drugs with conditions of safe use' (which some industry observers have referred to as a third class of drug product or 'behind the counter'/ 'BTC' products ) has put a new twist on existing legal and regulatory protocols and product commercialization in the OTC space. Self-diagnosis and self-care, two basic tenants of the current OTC paradigm may be supplemented with the assistance of a pharmacist and rapid diagnosis testing, thus leading to a multitude of questions ranging from scope of FDA authority to potential liabilities.
Learn to Prevent and Defend Enforcement Actions in the OTC Space by Mastering Critical AER, GMP and Recall Competencies.
This is the only legal and regulatory gathering specifically designed for the OTC drug industry which will specifically address enforcement activity and preventative measures based on real world examples impacting non-prescription pharmaceutical products. Present and former FDA enforcers and industry experts will help you:
Sign up by June 14, and receive a special way in advance rate of $1895.
Register today for the industry’s premier and most comprehensive legal and regulatory forum on OTC pharmaceutical products by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563, or logging on to AmericanConference.com/OTCDrugs.
Hear what delegates had to say about last year’s event:
Full conference details are on the way shortly. If you are interested in speaking at this event, contact email@example.com. For information on sponsoring or exhibiting at this event, contact Wendy Tyler at firstname.lastname@example.org.
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Tue, Oct 29, 2013
Wed, Oct 30, 2013
The Carlton on Madison
New York, NY