Preparing and Managing Rx-To-OTC Switch

Venue: The Caribe Royale Resort & Villas

Location: Orlando, Florida, United States

Event Date/Time: Jan 15, 2004 End Date/Time: Jan 16, 2004
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Description

The Institute for International Research is proud to bring you the Preparing and Managing an Rx-To-OTC Switch industry gathering. The mission of this program, developed for pharmaceutical switch teams, is to present specific information on how to improve processes to respond to the OTC switch paradigm shift at the FDA, which is not only proactively reviewing switches, but also demonstrating the authority to force Rx-to-OTC switches. This paradigm shift makes it critical to strategically prepare for forced switches, and learn important lessons from intended switches to maximize your financial assets. This unique conference clarifies the FDA’s authority and policies surrounding forced switches, illustrates regulatory compliance challenges of switched products, weighs the economic advantages and disadvantages of intended switches, and provides examples of how drug manufacturers can strategically determine when a switch is advantageous.

We are proud to bring you Rx to OTC switch thought leaders from Covington and Burling, Front Line Strategic Consulting Inc., Kline & Company, Consumer Healthcare Products Association, GlaxoSmithKline, Healthcare Compliance Packaging Council (HCPC), National Consumers League, Schachtel Research Centers, Inc., University of Pittsburgh, Wiley Rein & Fielding, and more who are working with the industry and the FDA, for both forced and intended switches. This expert-lead speaking faculty shares their experiences through case studies that discuss WellPoint’s Citizen petition, packaging and labeling requirements and developing the regulatory considerations of switching big brand name drugs to OTC.

SHAPE OF THE PROGRAM AGENDA
Join us on January 14th for pre-conference workshops. The half-day morning workshop, Designing Switch Trials to Understand and Validate Consumer Behavior, led by Gerald Dunaway, PhD, President of AMERITRIAL OTC RESEARCH, INC, is an in-depth practical study of real life consumer behavior sciences, gained through specially designed clinical trials that determine the viability of a drug as an OTC consumer product. The afternoon workshop, Rx-to-OTC Switch Fundamentals: Lessons from the Past and Applications for the Future, led by Laura A. Mahecha, MBA the Industry Manager, Kline Research at KLINE & COMPANY, looks at several Rx-to-OTC switches and uncovers the relative success and/or failure of each.

January 15th kicks off the main conference by focusing on the theme of the FDA paradigm shift: demonstrating the authority to force OTC switches, concentrating on revealing the details surrounding the FDA authority as well as current policies with a history of switches and an evolution of switches by Randy Juhl, PhD, Chair, First FDA Advisory Committee on Nonprescription Drugs. The morning continues with a look at the intertwined relationship of the consumer, pharmaceutical companies, and the FDA, clarified by a presentation by Dolly A. Judge, Federal Relations, PFIZER on forced switches.

Step up to the front lines of forced switches including:

Understanding current FDA policies on switch and reasons behind the paradigm shift
A case study on the FDA initiative to force switches on second generation antihistamines
An interactive panel discussion on how to proactively prepare for future switches
Day Two of the main conference focuses on the theme of strategically maximizing your company’s assets with well-planned Rx-to-OTC switches whether voluntary or forced. Regulatory, marketing and economic solutions are addressed beginning with an in-depth look at how to strategically switch a well performing drug by addressing how and why to prepare for an intended switch. In addition, learn how to:

Leverage consumer relationships to maximize a drug’s OTC success
Identify how to comply with OTC packaging and labeling requirements
Understand what makes an acceptable switch application
The Preparing and Managing Rx-To-OTC Switch conference offers case studies that illustrate and clarify the specific challenges of intended or forced switches and how switch professionals are strategically marketing the products for maximum economic value. It is a conference designed for the range of professionals on a switch team, including marketing, legal and regulatory professionals.

KEY OPPORTUNITY FOR LEARNING AND NETWORKING
Join the Rx to OTC Switch conference that addresses the paradigm shift at the FDA for the future of many drug classes. Address the specific obstacles that challenge intended or forced switches and learn strategies for overcoming compliance, economic, marketing, and safety switch roadblocks. We have included Q & A sessions at critical points in the program to ensure that you have ample opportunity to voice your questions, clarify your interpretation of our faculty’s recommendations and openly exchange your experiences for maximum learning. In addition, refreshment breaks and round table luncheons are planned to enhance your networking opportunities. Don’t miss this unique opportunity to talk one-on-one with our experts and your industry colleagues to compare notes and establish contacts with others who are facing the similar challenges in deciphering the information about the FDA intentions for OTC switches.

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