American Conference Institute's 3rd Annual

Legal, Regulatory and Compliance forum on Over the Counter Drugs

A comprehensive guide to the latest developments affecting non-prescription drug products

Monday, October 27 to Tuesday, October 28, 2014
The Carlton Hotel, New York, NY


Earlier this year, the FDA announced that the OTC Drug Monograph System and OTC Drug Review Process will be overhauled to meet the current needs of OTC manufacturers. The modernization of the Monograph System will revolutionize the OTC drug industry and change the way that over the counter drugs and consumer healthcare products reach the shelves. Billions of dollars are at stake as the OTC drug industry anxiously awaits the FDA’s proposals and ponders how this will impact business practices and profits.

In addition to scrutinizing the current OTC Drug Monograph System, the FDA together with the Engelberg Center for Health Care Reform at the Brookings Institute, continues to explore the NSURE Initiative (Nonprescription Safe Use Regulatory Expansion) which seeks to bring certain nontraditional prescription drugs to patients and consumers as over the counter drug products. The NSURE Initiative still remains controversial with OTC manufacturers and other stakeholders, including pharmacists and physicians as there are questions and concerns over how NSURE may impact not only the industry and new stakeholder dynamics, but also interactions with the consumer-patient and potential liabilities which may result from this new juxtaposition.

Both Monograph Modernization and NSURE are industry game changers which while having potential for new business opportunities, also present new dilemmas and compound existing ones. In response to these new challenges, and existing ones, American Conference Institute’s (ACI’s) 3rd Annual Legal, Regulatory, and Compliance Forum on Over the Counter Drugs will help you thoroughly comprehend the evolving OTC paradigm and develop compliant strategies which will enable you to still thrive within such a tumultuous setting. By attending this exclusive event, you will hear the latest developments impacting the legal and regulatory framework for the industry from more than twenty-five distinguished speakers.

ACI has designed this unique program to address the needs of the OTC drug industry. Legal and regulatory experts in the OTC space will provide you with the critical information you now need to:

  • Predict how the FDA will implement significant changes to the Monograph System, thereby changing how OTC drugs get approved
  • Extract the fine points of the NSURE Initiative and track the results of increasing access to nonprescription drugs
  • Overcome legal and regulatory hurdles associated with novel Rx-to-OTC switches
  • Reposition your company in light of the recent M&A activity among OTC drug companies
  • Develop social media, advertising, and trademark strategies for OTC drugs while identifying the legal pitfalls
  • Comprehend the importance of patent strategies in the OTC space
  • Appreciate the unique challenges associated with the homeopathic pharmacopeia
  • Understand the implementation of more stringent regulations for pediatric OTCs
  • Develop a global strategy for over the counter drugs

This is the only event where industry insiders will meet to discuss the legal and regulatory policies specifically impacting enforcement activity and related civil class action litigation in the OTC space. Faculty members will help you design strategies for establishing recall protocols, developing AER and cGMP best practices, which will help you avoid enforcement actions and class action suits.

To enhance and complete your conference and networking experience, attend one or both of the following strategies sessions:

MONDAY, OCTOBER 27, 2014 | 9:00 am – 12:00 pm
A: Domestic and International OTC and Consumer Health Care Products 101: Understanding and Re-Evaluating the Essentials of OTC-Ness for an Evolving U.S. and Ex-U.S. Health Care Marketplace

WEDNESDAY, OCTOBER 29, 2014 | 9:00 am – 12:00 pm
B: Defining Rx-to-OTC Switch Strategies To Build Sales, Boost Profit Margins and Provide a Platform for Sustainable Differentiation Amid Regulatory Uncertainty

Register today by calling 888-224-2480 or visiting us online at www.AmericanConference.com/OTCDrugs.