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Ottawa Marriott Hotel

Oct 17, 2016 1:30 PM - Oct 17, 2016 5:00 PM

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

Course 2: Innovation in Rx-to-OTC Switch


Short Courses are not included in the conference registration
and require an additional fee.

Short Course Registration: 8:00AM-5:00PM

The nonprescription market is one that is attractive to companies due to perceptions that the regulatory requirements and timelines are more advantageous. With the ability to do direct-to-consumer advertising and limited price controls, the regulatory professional is often solicited to evaluate the potential applicability of the switch process to many drug candidates. As the switch process is one that involves regulators at both the federal and provincial level, a detailed understanding of the process is crucial. When asked to evaluate potential switch candidates, regulatory professionals need to be able to answer the following questions:

  • How long will the switch take and what will it cost?
  • Will competitors be able to use the switch to their advantage?
  • Will the labeling be similar? Are there any specific packaging requirements (such as tamper/child-resistant)? Can we add promotional claims to the packaging?
  • What data is needed to support the switch?
  • Will we be subject to PMORB rules regarding pricing?
  • How will this affect provincial reimbursement?
  • Will we be able to advertise and sample the product to the public?
  • What are the differences between the NDSAC schedules and what do they mean for our product?

Return to DIA Annual Canadian Meeting 2016

Learning objectives

At the conclusion of this short course, participants should be able to:

  • Review the process to switch a RX product to OTC status
  • Discuss the challenges and benefits in Rx-to-OTC switch for key stakeholders

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