PrimeVigilance homepage
PHARMACOVIGILANCE

Pharmacovigilance Operations – Postmarketing

ICSR – individual case safety report

‘ICSR’ refers to an Individual Case Safety Reports which must be compiled for each instance of a suspected or confirmed adverse event and submission of such report to the Competent Authority (CA) of the Member State.

Read more

Expedited reports

Remaining compliant throughout all the changes to EU legislation can be a challenging endeavor for any company. This is particularly the case with Expedited Reporting – one of the pillars of all EU pharmacovigilance work.

Read more

Literature screening

Why is Screening of Literature Important?

Read more

PSUR / PBRER – Periodic Safety Update Report

Periodic safety update reports (PSUR) are required for all products that have marketing authorisation in the EU.

Read more

Safety signals

Business-Critical Responses – Your Processing of Safety Signals

Read more

  • Discover how we can help you

    CONTACT US

    • This site uses cookies to personalise and customise your experience. By clicking “I Accept", you consent to cookies in accordance with our privacy policy.

    I accept
    Cookie Settings
    Privacy Settings saved!
    Cookie Settings

    When you visit any web site, it may store or retrieve information on your browser, mostly in the form of cookies. Control your personal Cookie Services here.

    Necessary Preferences Analytics Marketing Privacy Policy
    These cookies are necessary for the website to function and cannot be switched off in our systems.
    Technical Cookies
    In order to use this website we use the following technically required cookies
    • wordpress_test_cookie
    • wordpress_logged_in_
    • wordpress_sec
    Cloudflare
    • __cfduid
    Decline all Services
    Accept all Services