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
Understand how the FDA’s NSURE Initiative Will Reshape the Tenants of the Current OTC Paradigm of Self Diagnosis and Self Care
FDA’s NSURE (Nonprescription Safe Use Regulatory Expansion) Initiative which seeks to establish a new paradigm for ‘OTC drugs with conditions of safe use’ will undoubtedly alter existing legal and regulatory protocols and product commercialization in the OTC space. Pharmacist assistance coupled with the use of new technologies and rapid diagnostic testing would in certain instances supplement the current OTC paradigm of self-diagnosis and self-care, thus leading to a multitude of controversies ranging from scope of FDA authority to potential liabilities. Additionally, the granting of OTC status to non-traditional switch candidates such as Oxytrol and the controversy over levonorgestrel also known as Plan B have led to new questions concerning how the NSURE Initiative may also impact the Rx-to- OTC switch mechanism.
Prepare to meet the challenges of the rapidly evolving legal and regulatory landscape of the non-prescription drug industry.
To help you make sense of the NSURE Initiative and in furthering the objectives of our inaugural OTC conference, ACI’s Second Annual Legal, Regulatory and Compliance Forum on Over the Counter Drugs will help you thoroughly comprehend the continuing evolution of the OTC landscape. By attending this event, you will understand how these latest developments will impact the existing legal and regulatory structures which frame the OTC environment.
A distinguished faculty of over two dozen leading legal and regulatory OTC experts — including current and former FDA representatives — 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 umbrella branding; and the modernization of the monograph system. They will provide you with the critical information that you now need to:
Prevent and Enforcement Actions and Civil Litigation 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 address enforcement activity and preventative measures based on real world examples impacting non-prescription pharmaceutical products. Present and former FDA and FTC enforcers, NAD representatives and industry experts will help you:
Benefit from Special Training and Strategy Sessions that will Address the Legal and Regulatory Essentials of OTCs and Intricacies of Commercialization.
To enhance and complete your conference and networking experience, attend one or both of the following strategy sessions:
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 www.AmericanConference.com/OTCDrugs.
- click image for pdf -
- Actions -
- Share -
Tue, Oct 29, 2013
Wed, Oct 30, 2013
The Carlton on Madison
New York, NY