[h3]Interactive Series of Four Webinars: Spring 2020[/h3]
The Rx-to-OTC Switch represents an important opportunity to extend product lifecycle and create a permanent annuity which helps consumers manage their own care and reduce burden on the healthcare system. There exists a legacy of essential OTC products which underwent this challenging process and are now mainstays of self-care. Learn from two of industry’s recognized experts providing an authoritative and insightful examination of the regulatory process and unique data requirements needed to support a switch application to the US FDA.
Topics include switch rationale and product assessment, special consumer studies required for label development, safety and efficacy expectations, cutting-edge digital innovations and collaboration with FDA. Participants from both prescription drug and consumer product organizations will benefit from understanding distinct commercial, regulatory and research perspectives.
The participant will gain a fundamental understanding of the OTC Switch process in the US, including product and therapeutic criteria, working with FDA, types of consumer behavior studies, and data analyses required for a successful development program.
Series Dates: February 27, March 12, March 26, April 9
Webinar Duration : 12 – 1:00 pm EST (60 minutes)
Cost: Register for the entire series for a bundled price of $600. Single sessions available for $250.
[button_large color=”orange” url=”/event-registration/?ee=226″]Register for Entire Series [/button_large]
[h3]Session 1: Evaluating a Switch Candidate and Creating a Strategy: Business, Regulatory and Scientific Considerations[/h3]
Thursday, February 27, 2020
Key Presentation Topics:
– Course introduction and overview
– The business case for switch
– Traditional switch criteria: Drug, indication and target population
– Data Gap Analysis
– Benefit/Risk assessment
– Public health rationale
– Determining the regulatory strategy and working with FDA (Meeting Types and Advisory Committee)
– Consumer Development Program and FDA interactions
Learning Objectives:
– The participant will comprehend the approach for evaluating a Switch opportunity.
– The participant will comprehend the most common elements of a Consumer Development Program.
– The participant will comprehend FDA’s expectations for a new Switch candidate.
[button_large color=”orange” url=”/event-registration/?ee=227″] Register for SESSION 1 [/button_large]
[h3]Session 2: Consumer Behavior Studies[/h3]
Thursday, March 12, 2020
Key Presentation Topics:
– Developing the labeling
– Stages of research (pre-tests, pilot, pivotal, formative, summative)
– Sequencing and conduct of studies
* Label Comprehension
* Self-Selection
* Human Factors
* Actual Use
– Available FDA Guidance documents
– Variants, hybrids, and customized studies
Learning Objectives:
– The participant will comprehend the key aspects of a Drug Facts Label and other associated labeling that may be incorporated into the Switch.
– The participant will be able to compare and contrast key types of consumer behavior studies.
[button_large color=”orange” url=”/event-registration/?ee=228″] Register for SESSION 2[/button_large]
[h3]Session 3: Establishing Safety and Efficacy in the OTC Environment[/h3]
Thursday, March 26, 2020
Key Presentation Topics:
– Changes in indication or dose from Rx product
– Consequences of misuse, misdiagnosis or undertreatment
– Rx label as driver for safety topics of interest
– Pharmacokinetics and drug metabolism
– Worldwide post-marketing experience
– Special safety studies and epidemiologic approaches
– Post-approval opportunities
– Leveraging Real-World Data
Learning Objectives:
– The participant will be able to describe the components of a safety program.
– The participant will be able to understand the key safety issues of concern for FDA.
[button_large color=”orange” url=”/event-registration/?ee=229″] Register for SESSION 3[/button_large]
[h3]Session 4: Innovative Approaches to a Switch Program[/h3]
Thursday, April 9, 2020
Key Presentation Topics:
– FDA Guidance for Innovative Approaches
– Labeling Innovations
* On/In package
* Digital
– Technology Innovations
* Controlled Access Modules
* Technology-enabled labeling
* Drug/device testing requirements
* Defining terms of approval for system, product, and category
– Overall course conclusions and key takeaways
Learning Objectives:
– The participant will understand the two main types of innovations mentioned by FDA in their Draft Guidance
– The participant will be able to describe the examples of these innovative approaches.
[button_large color=”orange” url=”/event-registration/?ee=230″] Register for SESSION 4[/button_large]