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Recorded Webinar
Assessing off-label drug use after approval : requirements, ethical considerations and methods
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
International regulatory authorities are very concerned about the potential for adverse medicine reactions caused by unapproved or off-label medicine use. Although off-label prescribing and medicine use is generally not illegal in any country, there is increasing evidence that certain off-label usages are not well supported by clinical trial evidence. In addition, it increasingly common for medicines to be approved with narrow defined indications to restrict use away from populations with increased risk. This approach is usually defined in a product-related post-marketing risk management plan and is usually accompanied by a requirement to assess medicine utilisation and describe the extent of off-label relative to off-label use. These requirements can present difficult challenges to medicine companies trying conduct these studies because they are asking physicians to report about unapproved usage of medicines.
In this webinar we will talk about how to perform medicine utilisation studies to meet regulatory requirements for post-approval data on off-label medicine use.
This webinar will teach you:
- Requirements for off-label medicine use assessments
- Ethical and legal challenges assessing off-label medicine use
- Methods and data sources for use in off-label medicine use assessment
Who should attend
Anyone who is interested to learn more on Ethical and legal challenges assessing off-label medicine
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