EXTEDO Free Webinar: how EXTEDO's Pharmacovigilance Database and Reporting Solution can Simplify Drug Safety Management

Agenda for Webinar on November 7th

Speaker, Dr. Reinhard Nibler, will discuss drug safety issues and how EXTEDO's PcVmanager can help simplify the compliance process.

During the one hour webinar Dr. Nibler will cover the following topics:

PcVmanager - the All in One Pharmacovigilance Database System

Case creation, case import and follow-up: The basics of e-Pharmacovigilance Workflow: The different steps of case processing
Submission: Paper or electronic, U.S. or European Union - How to be prepared for all filing requirements
Search and Query: Get what you need quickly
Reports: Depict your results clearly

EXTEDO's PcVmanager is a drug safety management software solution based on the E2B and MedDRA standards that enables you to classify, create, review, submit, and maintain pharmacovigilance data and adverse event reports. PcVmanager helps you manage the life cycle of mandatory SUSAR and ICSR reports to the EMA (European Medicines Agency) and the NCAs via our integrated E2B gateway, as well as all reported Serious Adverse Events (SAE) for an overall safety re-evaluation.

PcVmanager fulfills the Adverse Events Reporting System (AERS) requirements of electronic submissions, streamlining the certificate controlled communication process using the FDA gateway and getting "real-time" acknowledgement of submissions.

A variety of regions are supported through different report formats, like MedWatch or CIOMS.

Duration - 60 minutes

Registration

Please note that there will be two presentation times on November 7th!

Starting Time for Session 1

3:00 p.m. European Time
2:00 p.m. UK Time
9:00 a.m. US East Coast Time (New York, EST)

Register for Session 1 please click here

EXTEDO Free Webinar: how EXTEDO's Pharmacovigilance Database and Reporting Solution can Simplify Drug Safety Management - Session 1


Starting Time for Session 2

8:30 p.m. European Time
7:30 p.m. UK Time
2:30 p.m. US East Coast Time (New York, EST)

Register for Session 2 please click here

EXTEDO Free Webinar: how EXTEDO's Pharmacovigilance Database and Reporting Solution can Simplify Drug Safety Management - Session 2