Overview

Quality of Periodic Safety Update Reports (PSURs) /Periodic Benefit Risk Evaluation Reports (PBRERs) became a major compliance issue globally, as the complexity of the documents increased hand in hand with unprecedented level of regulatory scrutiny and attention.
This practical training course will help industry professionals to keep up with the new demands. It introduces essential aspects of medical writing of aggregate safety reports (PSURs /PBRERs) in the context of current legal framework at the European and Global level.
Course participants will learn all they need to know about the requirements set out in the ICH E2C(R2) (plus Q&A Annex) guideline on the PBRER, EU Good Pharmacovigilance Practices (GVP) - Module VII, as well as global acceptability and local variability in the requirements.
This course will demonstrate best practices in source data collection, the essential role of quality checks (QC) during the process of report preparation, and the critical aspects of medical writing, including data selection and presentation.
Practical exercises involving key aspects of safety medical writing, based on real-life examples, will be included.
Participants will be provided with preparatory material to allow for maximum benefit from the team exercises.

Featured topics

Introduction to the PSUR/PBRER, general principles and structure
Planning process and interdepartmental responsibilities
Writing of PSUR/PBRER:

Introductory sections
Presentation of findings
Data evaluation
Benefit-Risk analysis
Critical parts

Who should attend?

This course is intended for professionals working within the pharmaceutical industry in pharmacovigilance, drug safety, regulatory, and medical writing positions. Professionals most likely to benefit from this training are newcomers to the medical writing and/or pharmacovigilance positions or writers/specialists with clinical medical writing experience who wish to extend their professional skills in aggregate reports.

Learning objectives

At the end of this virtual live training course, participants will be able to:

Understand interpretation and application of the ICH E2C (R2) guideline, including the associated Q&A
Understand and apply the EU GVP Module VII standards and templates
Learn how to overcome the most frequent challenges in managing a team of authors, getting the correct and complete source information, performing effective quality checks, editing and text vs. table presentation
Understand important legal and regulatory context of PBRER, including local regulatory intelligence tips
Understand key principles of safety medical writing

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 Requirement

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)

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Medical Writing of Periodic Safety Update Reports (PSUR/PBRER)