Your Expert Partner

Pharmacovigilance

 

Clinagil provides a complete range  of  pharmacovigilance services both in the pre- and post marketing phase of product life cycle.

 

Literature surveillance. Clinagil offer subscription to weekly worldwide literature surveillance of your individual products or complete product portfolio. You will be alerted by email with full reference details within hours after any new hit relevant to your products has been identified.

 

Case management  of  individual adverse events and reactions including medical evaluation, coding and expedited electronic reporting to Eudravigilance and national authorities.

 

Periodic safety update reports (PSURs) can be prepared both if Clinagil acts as your pharmacovigilance unit or as an ad hoc   service. Bridging and addendum reports can also be prepared. The report will include medically supported conclusion and     specific suggestion to product summary changes if necessary.

 

Annual safety reports with identification of new safety information can be prepared for submission to health authorities, ethics committees and for internal use.

 

Risk management and pharmacovigilance system. Clinagil can  review and/or audit you current system and help you develop and improve standard operating    procedures in order to assure compliance according to global pharmacovigilance requirements.  Training can be provided, to assure the changes are effectively implemented in your organisation.

 

Regulatory inspections. Preparation for a pharmacovigilance  inspection can be a major task. Based on practical experience Clinagil can help you with preparation, training and  follow up.