The electronic reporting of suspected unexpected serious adverse reactions (SUSARs) and individual case safety reports (ICSR’s) to EMEA and National Competent Authorities represents a major task in pre- and post-authorisation of a medicinal product.

Based on the ICH initiative a standard called E2B has been implemented by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 according to the EudraVigilance project to provide a common format for an electronic and efficient adverse event reporting.

PcVmanager has been implemented from the perspective of the Pharmaceutical Industry to enable its users to classify, create, review, submit and maintain adverse event reports.
PcVmanager is supported by an embedded Workflow Management and Reporting Component.
EXTEDO’s PcVmanager

EXTEDO developed the PcVmanager as a standardised software solution, especially for the life cycle management of mandatory SUSAR and ICSR reports to the EMEA and the National Competent Authorities as well as all reported SAE’s for an overall safety re-evaluation. The PcVmanager has been designed to be fully functional with elementary hard- and software.

EXTEDO’s standardised software solution PcVmanager is a high-quality and functional product for the straightforward drug safety management based on the E2B and MedDRA standards.
The Concept of PcVmanager

The E2B Specification is an international standard for creating and submitting electronic case safety reports across the entire life cycle of associated drug products. The E2B specifies the format and the structure of an electronic case safety report. The benefits of the PcVmanager include:

• Runs on various types of IT-infrastructures (standalone, groupware, DMS based, via the web)
• Customizable validation requirements to import E2B-XML files
• Very fast and easy search functions based on case report data or MedDRA codes
• Easy to learn and easy to use application to improve business processes
PcVmanager is the implementation of the E2B specification and much more. It ensures the fast and smooth functioning of creating and assessing reported adverse events and to adequately cover the regulatory requested case safety report and drug safety management:

• Fully compliant with the regulations, directives and the general guidance related to electronic reporting of adverse event reporting
• Support of SUSAR, ICSR, CIOMS I Reports, CIOMS Line Listings and Tabulated Summaries as well as MedWatch Reports
• Adverse Event Management
• Availability of all E2B specified fields
• Case tracking / history comments
• Case validation check
• Additional attachments for cases like CIOMS I, email, etc.
• Versioning of cases
• Extensible Reporting Capabilities
• Integrated MedDRA Browser
• Integrated E2B gateway for direct Submission to the EudraVigilance Clinical Trial Module (EVCTM) , the EudraVigilance Post-Authorisation Module (EVPM), national regulatory authorities and global trading partners gateway
• Ability to work with standardised gateway supporting the required encryption protocols AS2/AS1, etc.
• Integrated Workflow Engine and Task View
• Full Scalability (start small in a local environment)
• 21 CFR 11 compliant
Adverse Event Reporting via E2B

Once an adverse event report has been created, verified and validated it can be submitted to any competent agency, and/or business partners via:

• An E2B compliant gateway [EudraVigilance Gateway]
• XML import to EVPOST
• An E-Mail system as XML-file or document attachment
• Paper based reports [electronically and/or printed]
• As CIOMS I Form
• As MedWatch Form

Drug-specific adverse events can be managed in a very accurate and efficient manner. The PcVmanager has been designed as a client/server architecture allowing multiple users to access one adverse event report simultaneously.

Case Reports can be reviewed at different sites and imported on a central site via a corporate network based on the E2B Specification. If wanted, PcVmanager can easily be integrated into state of the art document management systems such as:

• CSC (formerly FCG) First Doc, First Point
• EMC Documentum Content Manager
• IBM Score
• Lascom
• Microsoft Sharepoint
• NextDocs
• OpenText Livelink
• QUMAS DocCompliance
• and others and connected to company specific databases.