Pharmacovigilance

SOPs and template for Pharmacovigilance are found below. This service is currently still being 
updated and expanded, so not all SOPs and their templates are available at this time. 

Further SOPs concerning Pharmacovigilance will continue to be added through 2011


Background

Pharmacovigilance is the ongoing and systematic monitoring of the safety of a product in the 
post marketing phase with the aim of discovering, evaluating and understanding its undesired 
effects, to take appropriate measures to minimize risks. The tasks and processes in 
pharmacovigilance are complex and highly regulated. Accordingly, it is important to hold SOPs that 
ensure that the appropriate processes in the company are performed in a consistent manner to 
meet the regulatory requirements.


Orders

You can order SOPs and associated Templates via the order form. After you placed your 
order, we will send a CD-ROM with the chosen documents. With opening the CD box, you agree 
on the purchase.

Please keep in mind that you can only order a Template if you also ordered the associated SOP.

The prices displayed below are applicable ONLY to marketing authorisation holders
and sponsors of clinical trials. Prices for service providers can be requested directly 
from BPI Service zu erfragen.


Description of SOPs and associated Templates
Pharmacovigilance (English)
Below you will find brief descriptions of all SOPs and Templates in English language that are currently offered by the BPI Service GmbH on the topic of 'Pharmacovigilance'. The document IDs correspond to the numbers in the order form. In parentheses you will find the prices of the documents.
 
PVSOP02EN - Case Management (250,-€)
This SOP describes the process of dealing with individual case reports: all process steps, i.e. receipt of notification, documentation, initial assessment, medical evaluation, follow-up practice, recording in the safety database, reporting and archiving, are described. This SOP and its templates are currently being updated to comply with the new Guidelines on Good Pharmacovigilance Practices. The new document versions will be available shortly.
 
 
PVTPL02EN - Form Initial Information non-PV-staff (90,- €)
Form for employees from a department other than the pharmacovigilance department for recording an incoming notification of a possible adverse reaction report.

Templates can only be ordered when ordering the associated SOP.
 
 
PVTPL03EN - List of Products and PV Characteristics (40,- €)
Template for creating a table on products and associated reporting obligations.

Templates can only be ordered when ordering the associated SOP.
 
 
PVTPL04EN - Master Sheet for PV Case File (40,- €)
Master sheet for creation of a case file in the pharmacovigilance department

Templates can only be ordered when ordering the associated SOP.
 
 
PVTPL05EN - Form Follow-up Information (HCP) (90,- €)
Questionnaire for follow-up information for health care professionals

Templates can only be ordered when ordering the associated SOP.
 
 
PVTPL08EN - Form Follow-up Information (non-HCP) (90,- €)
Questionnaire for follow-up information for non-health care professionals

Templates can only be ordered when ordering the associated SOP.
 
 
PVADD01EN - Archiving of Safety Relevant Documents (25,- €)
Addendum to the SOP PVSOP02DE with tabular presentation of proposals for archiving periods for different documents in the pharmacovigilance department

Templates can only be ordered when ordering the associated SOP.