Specialist Support Outsourcing

Risk Management Plan in Pharmacovigilance

All applications for marketing authorisation in the EU must include a detailed and complex Risk Management Plan (RMP). In addition, renewals for older or generic products require an RMP.

A new or updated Risk Management Plan in Pharmacovigilance may be required where there are certain variations to the marketing authorization. This requirement depends on the nature of the variation and may not be necessary in all circumstances. Our expert medical writers and Pharmacovigilance risk benefit specialists can advise both on the need for an abbreviated RMP and on its content. PrimeVigilance can help our clients determine important identified and potential risks for both detailed and abbreviated risk management plans.

PrimeVigilance, has extensive experience in writing RMPs, assessing risk benefit analysis, RMP maintenance, and in line with GVP Module V can advise or perform analysis of the effectiveness of the risk minimisation activities.

Risk Management PlanS: Compliant and Proactive
Just one of the pharmacovigilance services from PrimeVigilance

For more information contact PrimeVigilance today

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

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.

These cookies are necessary for the website to function and cannot be switched off in our systems.

In order to use this website we use the following technically required cookies
  • wordpress_test_cookie
  • wordpress_logged_in_
  • wordpress_sec

  • __cfduid

Decline all Services
Accept all Services