Overview

Download the justification letter and submit it to your manager for approval.

This virtual live training course is designed to provide a strong foundation in all important key aspects of European Clinical Pre- and Post-Marketing Safety regulatory requirements. This comprehensive and interactive five-day virtual live training course also includes highlights and updates on the pharmacovigilance legislation and the latest news on the international harmonisation and standardisation activities in pharmacovigilance.

It is also possible to register to each of the 4 course modules individually:

Module 1: Definitions and Methods in Pharmacovigilance
Module 2: Regulatory Aspects in Pharmacovigilance and Practical Examples
Module 3: Signal Detection and Management
Module 4: Risk Management

Participants said

"I would like to praise Jan Petracek and Gaby Danan for their knowledge and enthusiasm transformed in presentation."
Maja Vovk, PV coordinator, Medis d.o.o., Slovenia

"Very good course, a lot of materials with explanations and examples, the faculty members were excellent, the organisation was brilliant and the venue was very appropriate. Great! Thank you!"
Iliyana Mitova, Pharmacovigilance Assistant, Pharma Support Services Ltd., Bulgaria

"I really liked the presentation skills of Jan Petracek, even though I was less familiar with the topics presented by him, they were presented in a very clear, transparent manner. I did not get bored during the presentation and found the topics very interesting."

Who should attend?

This virtual live training course will benefit professionals with basic knowledge and experience in Pharmacovigilance or adjacent functions, for example, PV Officers, PV Specialists, PV Experts, PV Coordinators, Heads/Directors/Managers of Regulatory Compliance, Quality or Safety departments.

Level: Beginner/Intermediate

Learning objectives

Additionally to the five key topics, you should also be able to:

Understand basic definitions and methods in pharmacovigilance
Describe the expedited and periodic ICSRs reporting requirements in clinical trials and post-marketing including the medical evaluation
Understand the process of audits and inspections in pharmacovigilance
Understand the principles of signal management
Describe the components of the risk management

TECHNICAL REQUIREMENTS

To test your system compatibility, please click on the link: https://diaglobal.zoom.us/test

Operating Systems

Windows: XP 32-bit (SP3), 2003, Vista 32-bit/64-bit, Windows 7 32-bit/64-bit
Mac OS X: 10.5, 10.6, 10.7
Linux: 32-bit Ubuntu 10.x,11.x 32-bit Fedora 15/16, 32-bit Red Hat 5/6, 32-bit OpenSuSE 11.4

Minimum System Requirements

Windows: Processor – Requires Sun Java 5 or higher, Recommend ActiveX be enabled for Internet Explorer
Mac OS X: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access
Linux: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access

Browsers

Windows: Internet Explorer 6, 7, 8, 9, (Win7 Only), Firefox latest (32-bit), Chrome latest
Mac OS X: Safari 4-Mar; Firefox 2/3/3.5
Linux: Mozilla 1.7, Firefox 2/3/3.5

Internet Connection Speed

Windows: Intel or AMD processor (1GHz or faster), At least 512 MB RAM (at least 2 GB RAM for Vista)
Mac OS X: Intel processor, At least 512 MB RAM
Linux: At least 512 MB RAM

Display

800x600 pixel resolution or greater (1024x768 pixels recommended)

Program Committee

Wendy Huisman, PharmD Director
Vigifit, Netherlands
Fakhredin Sayed Tabatabaei, MD, PhD Senior Assessor
MEB, Netherlands

Digital Learning Catalog

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Have an account?

Joint DIA/MEB Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing Virtual Live Training Course