PV Processes In International Trials

Good afternoon PV colleagues

 

I wondered if you would all be able to help me?

 

We are currently opening a number of international studies both in and out of the EEA and we wondered how everyone else is approaching pharmacovigilance internationally?

 

I wondered if through this forum or outside of it anyone would be happy to share their experiences and their procedures?

 

For example, how do you ensure that the other countries are doing what is required of them in terms of onward reporting? 

 

We do currently have a system whereby each country has a specific trial co-ordinator who helps ensure that reporting requirements are met. For example they would be sent a copy of the DSUR so they can submit to their own competent authority and SUSAR submissions so they can onward report to the required bodies.

 

Thanks

 

Kelly

[Author]

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