Expedited reports

One of the most common causes of critical findings in Pharmacovigilance Inspections is the non-compliance with the expedited reporting (15 day) of spontaneous adverse drug reactions. PrimeVigilance place particular emphasis on the timely reporting of post-authorisation case reports. With a fully validated E2B compliant safety database (ArisgTM),  highly effective SOPs and operating guidelines, thorough staff training and a constant quality management system 'on time' reporting is a major priority. Reports may be made electronically or by hard copy as required by local regulations. As with clinical trial reporting PrimeVigilance may register and run electronic reporting systems such as EUDRAVIGILANCE. EMEA trained staff ensure compliance with the rigorous requirements' of such a system.

 

 

 

 

PrimeVigilance - Trained and on Time

- just one of the pharmacovigilance services from PrimeVigilance


 

For more information contact PrimeVigilance today


 

PrimeVigilance

in conjunction with Elliot Brown Consulting and Ergomed


 
More information on: non-compliance , expedited reporting , spontaneous adverse drug reactions , validated , compliant safety database , quality management system , eudravigilance