Webinar on How to assure
Good Pharmacovigilance Practices (GVP)?
Takeaway #1
GVP Reporting fundamentals
Takeaway #2
Invalid/Non reportable cases
Takeaway #3
Submission pre-requisites
Takeaway #4
Widespread GVP implementation
Webinar overview
Good Pharmacovigilance practices is a vast term that holds ample information about ‘How well’ pharmacovigilance as a discipline can be conformed.
It delineates compliance in accordance to overall Pharmacovigilance operations. This covers documentation, reporting timelines, monitoring, worldwide safety etc., such that the Regulatory Agencies can continuously monitor risk-benefit ratio that might be altered in evidence of more data gathered on the drug and event.
Good Pharmacovigilance practices is a vast term that holds ample information about ‘How well’ pharmacovigilance as a discipline can be conformed.
It delineates compliance in accordance to overall Pharmacovigilance operations. This covers documentation, reporting timelines, monitoring, worldwide safety etc., such that the Regulatory Agencies can continuously monitor risk-benefit ratio that might be altered in evidence of more data gathered on the drug and event.
As a Manufacturer or a pharmacovigilance service provider, this is critical not only from the Regulations perspective but also as a Company’s moral obligation to be vigilant of the products under their purview.