- This topic has 1 reply, 1 voice, and was last updated 1 year, 2 months ago by .
- You must be logged in to reply to this topic.
Relatively new to Pharmacovigilance and would be very grateful for some guidance please:
My scenario is a product approved in US and EU (but no clinical studies ongoing in either US or EU) and NDA holder/ MAH is Company#1, and the product is being studied in a clinical trial in Japan under a different Sponsor (Company#2, which has out licensed development rights from Company#1), I am trying to work out the cross-reporting requirements in US and EU from any SUSARs that might occur in the Japan clinical trial.
I think, for a Japanese SUSAR, we would need to cross report to both FDA and EMA. I get a bit confused whether the reports would be clinical trial 15-day reports (i.e. to IND rather than NDA and to EVCTM rather than EV postmarketing) even though there are no active clinical studies ongoing in US or EU, or if they are handled through post-marketing expedited safety reporting? I also think we would need to ask the Japanese Sponsor to unblind the SUSAR in order to be sure that it was related, before submitting to FDA and EMA (but the Japanese Sponsor is not happy with doing this). Is unblinding still essential in a scenario where the report is coming from a trial where we are not the direct Sponsor?
As a related question, if a clinical study with the same product were to be started in EU while the trial was ongoing in Japan, would this change reporting requirements in Europe?
Many, many thanks in advance.
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
|cookielawinfo-checkbox-analytics||11 months||This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".|
|cookielawinfo-checkbox-functional||11 months||The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".|
|cookielawinfo-checkbox-necessary||11 months||This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".|
|cookielawinfo-checkbox-others||11 months||This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.|
|cookielawinfo-checkbox-performance||11 months||This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".|
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.