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Hello PIPA
Can someone elaborate on what PV quality oversights are needed in an out licensing model ? When products are out licensed to a partner what minimal PV quality oversight is required?
Many thanksPV oversight depends upon the type of partner (e.g., Sponsor, Agent, Distributor etc.), product, territory covered, and the local regulations. It can also be influenced by where the MAHs HQ is as they will need to follow the local regulations.
There should be a PV agreement (also called a Safety Data Exchange Agreement (SDEA)) in place that defines how PV data will be manged and negotiating this can be a time consuming and challenging activity.
In terms of oversight, the expectation in the EU and UK is that all partners should be risk assessed (we use a questionnaire and consider the products involved, the volume of sales, reconciliation records etc.) and included in the MAHs audit schedule (we audit low risk partners every 5 years, but higher risk ones more frequently).
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