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ACI : Over the Counter Drugs : Overview

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.

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.

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:
  • Understand the interplay between OTC drugs introduced under this proposed new paradigm and other Rx to OTC switches
  • Identify prescription products that are appropriate candidates for an Rx to OTC switch and proposed OTC drugs with conditions of safe use
  • Examine the label as a means of advertising and promotion
  • Analyze the use of social media in OTC advertising
  • Overcome challenges with line extensions for monograph and NDA OTCs
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:
  • Understand the scope of FDA and DOJ - as well as FTC - enforcement in the OTC space
  • Overcome challenges in forming effective recall execution strategies 
  • Explore the link between recent  GMP  violations and enforcement activity in the OTC space
  • Establish internal AER review protocols and record keeping systems in accordance with inspection requirements
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:
  • “Great speakers and good presentations.  Very helpful.”
  • “A lot of really good information was presented.  I really like the case studies.”
  • “Great conference!  Excellent speakers – some brilliant!  Superb conference co-chairs!”
  • “Very informative.  The material is detailed enough to provide information and guidance while still being presented so that a wide audience can understand.”
  • “Lots of new learning.  Overall good and informative.”
  • “Good conference.  It was useful to hear the FDA perspective, and esp. the speakers from industry.”

Full conference details are on the way shortly.  If you are interested in speaking at this event, contact l.piccolo@americanconference.com.  For information on sponsoring or exhibiting at this event, contact Wendy Tyler at w.tyler@americanconference.com.